Case 1:15-cv-12298-NMG Document 1 Filed 06/10/15 Page 1 of 17

UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS

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EMILIAN PASZKO and JEFFREY FOWLER, )

on behalf of themselves and all others similarly

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situated,

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Plaintiffs,

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v.

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CAROL HIGGINS O’BRIEN, Commissioner of )

Massachusetts Department of Correction, in her )

official capacity, and MASSACHUSETTS

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PARTNERSHIP FOR CORRECTIONAL

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HEALTHCARE, LLC,

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Defendants.

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CIVIL ACTION NO.

CLASS ACTION COMPLAINT

Introduction

1. This is a class action that seeks declaratory and injunctive relief under 42 U.S.C.

§1983 for violation of the Eighth Amendment as a result of the deliberate indifference of

defendants, the Commissioner of the Massachusetts Department of Correction and the

Massachusetts Partnership for Correctional Healthcare, LLC (“MPCH”), to the serious medical

needs of plaintiffs and the members of the class, who are infected with the Hepatitis C virus.

Over 1,500 state prisoners in Massachusetts have Hepatitis C, but as of the present time only

three are being treated for it. For many of them, including plaintiffs and the members of their

class, the illness may progress toward end stage liver disease and death. A major advance in

treatment was made in 2014, with the introduction of medication regimens that have near-

perfect success rates, far fewer side effects, and a much shorter duration. Despite these

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advances, defendants have failed and refused to provide this new treatment to plaintiffs and the members of their class.
The DOC and MPCH have instead continued a years-long reduction in the number of patients treated for Hepatitis C; they have knowingly delayed evaluating prisoners, and they have consciously avoided knowledge of their treatment needs. Prisoners who ought to receive the new medications are not receiving them, and a vast number of prisoners with Hepatitis C are not being afforded the necessary testing to determine whether they too should receive treatment.
Plaintiffs Emilian Paszko and Jeffrey Fowler are two such prisoners. They bring this action on behalf of themselves and all other state prisoners with Hepatitis C to remedy defendants’ deliberate indifference to their serious medical need for treatment for their Hepatitis C. By not assuming the financial cost of Hepatitis C treatment, defendants are imposing a human cost on the prisoners in their care as well as on the population which will be at risk when these prisoners are released.
JURISDICTION AND VENUE 2. The Court has subject matter jurisdiction over plaintiffs’ claims pursuant to 28 U.S.C. §§1331 (federal question jurisdiction) and 1343 (civil rights jurisdiction). 3. Venue is proper pursuant to 28 U.S.C. §1391(b).
PARTIES 4. Plaintiff Emilian Paszko is currently incarcerated at MCI-Shirley Medium in Shirley, Massachusetts, a penal institution operated by the Massachusetts Department of Correction (“DOC”). Mr. Paszko has Hepatitis C, and without treatment, he will suffer from the complications of this disease, up to and including death. He brings this action on his own behalf and on behalf of all prisoners in DOC custody who have Hepatitis C.
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5. Mr. Paszko suffers from serious complications from Hepatitis C that have required multiple hospitalizations in the last two years. A gastroenterologist has noted that Mr. Paszko “would certainly be a candidate” for treatment with the newest Hepatitis C medications, if they were available within the DOC.
6. Plaintiff Jeffrey Fowler is currently incarcerated at Old Colony Correctional Center in Bridgewater, Massachusetts, a penal institution operated by the DOC. Mr. Fowler has Hepatitis C and, without treatment, he will suffer from the complications of this disease, up to and including death. He brings this action on his own behalf and on behalf of all prisoners in DOC custody who have Hepatitis C.
7. Non-invasive testing has confirmed that Mr. Fowler has significant liver fibrosis (scarring). In 2014, Mr. Fowler was treated with triple therapy, a medication regimen that preceded today’s medication regimens, but that treatment was unsuccessful.
8. Defendant Carol Higgins O’Brien is the Commissioner of the Massachusetts DOC, and she is being sued in her official capacity. The DOC is an agency of the Commonwealth of Massachusetts that is charged with the care and custody of state prisoners and has a constitutional obligation to attend to the serious medical needs of the prisoners in its custody. Defendant O’Brien is aware of the facts alleged below, and she has acted, and continues to act, under color of law, custom and policy with respect to her failure and refusal to provide constitutionally adequate care and treatment to plaintiffs and the members of their class.
9. Defendant Massachusetts Partnership for Correctional HealthCare, LLC (“MPCH”) is a Massachusetts corporate entity with a principal place of business in Westborough, Massachusetts. MPCH is the health care provider for the DOC, pursuant to a contract between the two parties. Since July 1, 2013, MPCH has been responsible for providing adequate medical
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care to all prisoners in DOC custody. MPCH is aware of the facts alleged below, and has been acting, and continues to act, under color of law, custom and policy with respect to its failure and refusal to provide constitutionally adequate medical care and treatment to plaintiffs and the members of their class.
CLASS ACTION ALLEGATIONS 10. This is a class action under Rule 23(a) and (b) of the Federal Rules of Civil Procedure. 11. Plaintiffs are representatives of a class composed of all prisoners in the custody of the DOC who have Hepatitis C. 12. Membership in the class is so numerous that joinder of all members is impracticable. Over 1,500 DOC prisoners have Hepatitis C at any given time, and the population changes as persons are admitted and released. 13. Plaintiffs’ claims involve common questions of law and fact that are typical of the claims of the class as a whole. The claims concern defendants’ protocol and practice for treating Hepatitis C, which is applicable to all prisoners with Hepatitis C. Common questions include (1) whether treatment for Hepatitis C is a serious medical need; (2) whether defendants have been deliberately indifferent to the serious medical needs of plaintiffs and the members of their class; (3) whether defendants have failed and refused to provide the necessary staging of Hepatitis C patients in accordance with the prevailing standard of care, including the pretreatment testing and specialist consults that are needed to determine the severity of the disease and the need for treatment; (4) whether defendants have failed and refused to provide treatment for plaintiffs and the members of their class with the newest, most effective medications for Hepatitis C in accordance with the prevailing standard of care; and (5) whether
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defendants’ failure to provide treatment to plaintiffs and the member of their class in accordance with the prevailing standard of care for treatment of Hepatitis C has put plaintiffs and the members of their class at risk of serious harm.
14. These common questions predominate over any questions affecting only individual class members. Defendants have acted and refused to act on grounds generally applicable to the class so that final declaratory and injunctive relief would be appropriate to the class as a whole.
15. Plaintiffs have a strong personal interest in the outcome of this litigation, and they are represented by competent counsel who will adequately and fairly protect the interests of the class.
16. A class action is superior to any other available method for a fair and efficient adjudication of this controversy. Separate actions by individual members of the class would create a risk of inconsistent or differing adjudications and delay the ultimate resolution of the issues at stake.
FACTS Hepatitis C Defined 17. Hepatitis C is a blood borne disease caused by the Hepatitis C virus (“HCV”). The virus brings about inflammation that damages liver cells. It is a leading cause of liver disease and liver transplants. 18. There are several different genotypes of Hepatitis C, with subtypes. Genotype 1 is the most common type of Hepatitis C in the United States. 19. Approximately eighty percent of people who become infected with the Hepatitis C virus will develop chronic Hepatitis C.
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20. Chronic Hepatitis C patients develop fibrosis (liver scarring), which can worsen liver function until the patient develops cirrhosis. Ultimately, patients may end up with end stage liver disease, cancer, or other serious illnesses. Some patients will need a liver transplant, and others will die.
21. Hepatitis C is transmitted by infected blood. Methods of transmission include intravenous drug use (via shared equipment), tattooing (same), blood transfusions (with infected blood, largely before regular screening of donated blood began), and sex. Intravenous drug use is the most common means of transmission in the U.S.
22. It is widely accepted that the number of reported cases of Hepatitis C nationwide understates its actual prevalence. In 2000, the United States Surgeon General called Hepatitis C a “silent epidemic,” and estimated that as much as two percent of the adult U.S. population had Hepatitis C.
23. The last decade has seen a spike in reported cases of Hepatitis C among young people. This increase in new cases of Hepatitis C is largely attributable to the increase in opioid addiction and the resulting use of intravenous drugs.
24. The incidence of Hepatitis C is not diminishing, and its effects are worsening. In 2011, the CDC reported that Hepatitis C had overtaken HIV as a cause of death.
Hepatitis C in Prison 25. The prevalence of Hepatitis C in prison is higher than in the general population. It is estimated to be anywhere from 9.6% to 41.1% of the prison population nationally. As many as half a million people in prison at any given time have Hepatitis C. 26. In 1997, according to one study, 29% to 43% of all people infected with Hepatitis C in the United States passed through a correctional facility.
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27. In the Massachusetts Department of Correction, over 1,500 of the ten thousand prisoners are known to have Hepatitis C.
History of Hepatitis C Treatment 28. Treatment exists for chronic Hepatitis C. The available treatments have changed over time. 29. In 1991, a drug called Interferon was approved to be used alone. Seven years later, the FDA approved the use of Ribavirin alongside Interferon, and in 2001, Ribavirin was paired with Pegylated Interferon. This regimen was referred to as combination therapy. 30. Combination therapy was marked by a long duration of treatment – 48 weeks. The medications had significant side effects. Interferon in particular was troublesome, causing such side effects as depression, thrombocytopenia, and loss of bone marrow. While research had shown that combination therapy was very effective against Genotypes 2 and 3, only around 60% of patients with Genotype 1 taking combination therapy achieved a Sustained Viral Response (“SVR”) – an undetectable viral load six months after completing treatment, which is considered a cure. 31. The standard of care after 2001 was to treat Genotypes 2 or 3 with combination therapy, and to treat Genotype 1 with combination therapy if the patient had reached a certain stage of liver damage, typically measured by a liver biopsy. If after treatment the virus was not suppressed, or if it was suppressed during treatment but later returned, there was no other treatment available for the so-called nonresponder or relapser. 32. 2011 saw the FDA approval of two protease inhibitors that produced better results when either one was taken with combination therapy, especially for Genotype 1 (SVR of 6080%).
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33. The standard of care evolved to include so-called triple therapy – one of the two protease inhibitors, taken with Interferon and Ribavirin – for Genotype 1 patients. Triple therapy was effective on nonresponders and relapsers, giving them a new option and potential cure.
34. The duration of treatment with triple therapy remained the same as with combination therapy, as did the side effects. The expense increased because of the additional medication.
35. In 2013 and 2014, the FDA approved more new antiviral medications. These medications can now be taken as part of an Interferon-free regimen. The change is dramatic; the worst side effects are avoided. The regimen is a much shorter duration – 12 weeks for some, 24 weeks for others. Best of all, the success rate for these regimens is better than combination or triple therapy – well over 90%, including for nonresponders and relapsers.
36. There have also been changes in how the disease is monitored. To measure fibrosis, providers now generally forego a liver biopsy in favor of non-invasive tests. Blood tests can offer an accurate assessment of liver fibrosis, and these tests can be coupled with certain types of scanning if desired.
37. These new developments in staging the disease, and treating it, have eliminated the barriers to a cure.
History of Hepatitis C Treatment in the DOC 38. The DOC has treated some prisoners for Hepatitis C since approximately 2000, with combination therapy the treatment of choice since 2002. 39. In about 2002, the DOC implemented a Hepatitis C treatment protocol, with input from its health care contractor and the Department of Public Health.
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40. The treatment protocol contained directions for screening of prisoners. Those prisoners considered at high risk would be given an HCV antibody test (detecting whether HCV antibodies are present in the blood).
41. If a prisoner tested positive for HCV antibodies, confirmatory testing would be done, including liver function tests and measurement of the viral load (the amount of virus in the blood).
42. Laboratory testing and a medical assessment would be done to determine whether the prisoner should receive a liver biopsy. A biopsy provided the best evidence of whether there was fibrosis of the liver.
43. If the biopsy resulted in a recommendation for treatment, the prisoner did not necessarily receive treatment right away. He or she was instead placed on a wait list. The DOC and its healthcare contractor rationed treatment, authorizing a certain number of “treatment slots” – a maximum number of prisoners who could receive treatment at one time. Prisoners were selected from the wait list for treatment based on the severity of their disease, and other factors.
44. The DOC and its health care contractor paid close attention to the number of prisoners receiving combination therapy and to how much money had been spent on Pegylated Interferon and Ribavirin. Monthly reports calculated both numbers.
45. The DOC’s health care contractor had a Hepatitis C program manager – a staff member dedicated to overseeing Hepatitis C treatment in the DOC. The manager followed the number of Hepatitis C cases, managed a database of Hepatitis C prisoners, maintained the wait list, and participated in the determination of who received treatment and when.
46. The treatment protocol contained several exclusions, some of which were tied to
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prison issues rather than medical issues. For example, prisoners who were too close to their release date would not receive treatment, the stated concern being that the prisoner would not complete the treatment after release. Moreover, prisoners who received certain types of disciplinary reports would be rendered ineligible for treatment.
47. By 2011, when triple therapy arrived nationally, the DOC and its health care contractor had been convening a Hepatitis C Task Force for two years. The Task Force was comprised of representatives from the DOC, its health care contractor, and the Department of Public Health.
48. The Task Force and its members were well aware of the two new protease inhibitors before their approval by the FDA. Nevertheless, the treatment protocol was not amended in a timely way when triple therapy became available.
49. A sizable number of prisoners in the DOC were nonresponders or relapsers. These patients in particular had had little hope of cure, until the arrival of triple therapy. Most or all of them had not been staged (evaluated) in a long time, and did not know how much farther their liver fibrosis had progressed.
50. New prisoners were also entering DOC custody with Hepatitis C, specifically with Genotype 1, for which triple therapy was superior to combination therapy.
51. Many of these prisoners sought staging and a determination of their eligibility for treatment. Prisoner advocates inquired about how the DOC and its health care contractor planned to implement triple therapy, and especially how it planned to conduct the necessary testing for nonresponders and relapsers – patients who needed to be brought back into the treatment pipeline.
52. For nearly two years, prisoners and their advocates were told only that the treatment
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protocol was “under review.” Heavy emphasis was placed on the fact that the medications were “new,” even though their arrival had been anticipated for years, and even as months passed without a single DOC prisoner receiving triple therapy.
53. In July of 2012, the DOC advised that its task force continued to meet, that its health care contractor was still working on a revised protocol, and that after the protocol was submitted, the DOC would then review it further. There was no timetable for implementation of the new protocol.
54. On October 3, 2012, the DOC issued a Request for Response – a call for bids on a new health care contract. In its Request, the DOC advised that it was still “in the process of implementing a new Hepatitis C protocol.”
55. Finally, in 2013, a few DOC prisoners began to receive triple therapy. Very few prisoners were treated.
56. The DOC has for years reduced Hepatitis C treatment, as has MPCH since its arrival in 2013 as Doc’s health care contractor. In Fiscal Year 2009 (July 2008 – June 2009), an average of 81 prisoners were taking Hepatitis C medications in any given month. In Fiscal Year 2014, that number had dropped to 16.
57. This dramatic reduction in the number of treatment slots was coupled with a failure to stage Hepatitis C patients. With nonresponders and relapsers joining the treatment-naïve Hepatitis C patients, the situation called for a rigorous, speedy process of conducting the necessary tests. This task should have been made easier since the standard of care permitted non-invasive tests, rather than liver biopsies, to measure liver fibrosis. But such a process never emerged.
58. In late 2013, the FDA approved Sovaldi and Olysio, which brought an even higher
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cure rate for Genotype 1 (when taken with Interferon and Ribavirin). 59. Within their joint Pharmacy & Therapeutics Committee, defendants first discussed
Sovaldi in April of 2014. In the months leading up to that meeting, defendants had reduced the number of prisoners on triple therapy or combination therapy.
60. By the time of the August 2014 Pharmacy & Therapeutics Committee meeting, defendants reported having an interim guideline for use of Sovaldi, and three prisoners were said to have been evaluated and cleared to begin therapy that month.
61. However, at the September 2014 meeting, it was reported that in all DOC facilities there were only six prisoners taking combination therapy, six prisoners taking triple therapy, and no prisoners taking Sovaldi. The three prisoners referred to in paragraph 60, above, were now said to be ready for treatment “once operational processes are put into place.”
62. By October of 2014, there were only five prisoners cleared to start treatment with Sovaldi “once operational processes are put into place.” Meanwhile, the number of prisoners receiving combination or triple therapy dropped to six.
63. The FDA approved Harvoni (in October 2014) and Viekira Pak (in December 2014), marking the arrival of the first Interferon-free treatment regimens. These regimens also enjoy near-perfect cure rates.
64. Nevertheless, only two or three prisoners have been treated with one of the new regimens. As of February 2015, there were only three prisoners taking Hepatitis C medications of any kind. Defendants have not changed their protocol to recognize the new reality in Hepatitis C treatment, and they have done nothing to conduct the necessary pre-treatment testing of the many prisoners – the nonresponders, relapsers, and treatment-naïve – who may benefit from treatment now or in the future.
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65. Moreover, defendants have not addressed their protocol’s outdated treatment exclusions. For example, disqualifying prisoners based on an upcoming release date made some sense under a 48-week combination therapy regimen, but today the standard treatment time is 12 weeks. Prisoners with decompensated cirrhosis of the liver used to be excluded, but the new regimens are effective in these cases. Excluding prisoners who have contraindications to taking Interferon or Ribavirin is no longer necessary or appropriate.
Conscious Disregard of Serious Needs by Delay and Denial 66. In years past using combination therapy, the DOC rationed treatment, delaying care for many prisoners. However, they at least treated eighty or more Hepatitis C prisoners at a time. The DOC provided combination therapy despite its challenges, which included a long duration of treatment, significant side effects (some of which would require abandoning treatment, and some of which could only be treated at further expense), only a moderate chance of success (for Genotype 1), and high-priced medications. 67. Today, the standard of care includes Interferon-free regimens. These regimens are of much shorter duration, lack the worst side effects, and offer a near-certain cure. Defendants, however, are only treating three prisoners with Hepatitis C, and they have treated almost no one with the newest regimens. 68. The high cost of Hepatitis C medication encourages systemic delay – delay in the defendants’ approval of new medications, delay in amendments to the treatment protocol, delay in the staging of the many prisoners who need to know whether they should receive treatment, and delay in treatment itself. 69. When prisoners inquire about Hepatitis C treatment, defendants respond vaguely. They indicate that the prisoner will have a chronic disease appointment soon, or that the
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Hepatitis C protocol is under review. 70. There is no legitimate excuse for delay in amending the treatment protocol, in
staging, or in prescribing treatment. Defendants knew that the Interferon-free regimens were coming long before they were approved by the FDA.
71. In fact, defendants denied triple therapy to many prisoners by pointing to the imminent arrival of Interferon-free regimens. They have saved money by deferring treatment and reducing the number of treatment slots, in anticipation of this time.
72. The DOC and its health care contractor knew before 2011, when triple therapy arrived, that they needed to bring a large number of prisoners who were previously ineligible for treatment – particularly nonresponders and relapsers – back into the treatment protocol, by ordering pre-treatment tests and staging them. They failed to do so then, and defendants are failing to do so now.
73. Defendants’ now-outdated treatment protocol contemplated a staging process of twelve months. It is taking far longer than that to work up most prisoners, with some not being ordered the necessary tests or consults at all, despite the staging process being easier and less invasive than ever before.
74. The result of this foot-dragging is that defendants do not know who needs Hepatitis C treatment now, or which prisoners need treatment the most. By their actions, defendants have made a conscious choice not to know.
75. Moreover, to treat only the most severe cases of Hepatitis C is no longer the standard of care. At a minimum, prisoners with a moderate stage of liver fibrosis (including Stage 2 of the Metavir scale, or Stage 3 of the Ishak scale) should be treated. In the past, prisoners with moderate fibrosis might be encouraged to wait for the arrival of new regimens.
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Those regimens are now here. 76. Having chosen to delay treatment for so many prisoners from 2011 to 2015, and
having saved a significant amount of money in so doing, defendants cannot now be heard to complain about cost, or to delay treatment any longer under the guise of further deliberation.
77. Defendants should be adhering to specific guidelines and deadlines for follow-up testing and evaluation of prisoners who, for whatever reason, have been deemed ineligible for treatment.
Risk of Serious Harm That Results 78. Some 20% of people with Hepatitis C will progress toward cirrhosis, putting them at risk of end stage liver disease, cancer, and death. 79. Hundreds of DOC prisoners are at risk of serious harm, including cirrhosis, end stage liver disease, cancer, and death, if they do not receive timely and adequate monitoring, testing, and treatment. 80. The risk of serious harm and death is not hypothetical. Other prisoners were forced to wait while their untreated Hepatitis C led to their deaths.
CLAIM FOR RELIEF CRUEL AND UNUSUAL PUNISHMENT IN VIOLATION OF THE EIGHTH AND
FOURTEENTH AMENDMENTS TO THE UNITED STATES CONSTITUTION 81. Plaintiffs restate and reallege paragraphs 1-80 as if fully set forth herein. 82. In all relevant aspects, defendants have acted, and are acting, under color of law,
custom and policy. 83. By their policies, practices, and acts, defendants are violating the rights of plaintiffs
and the members of their class to be free from cruel and unusual punishment guaranteed by the Eighth and Fourteenth Amendments to the United States Constitution and 42 U.S.C. § 1983 as a
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result of their deliberate indifference to the serious medical needs of plaintiffs and the members of their class for immediate and effective treatment for Hepatitis C.
PRAYER FOR RELIEF 84. WHEREFORE, plaintiffs request that this Court grant them the following relief: a. Certify that this action be maintained as a class action of all prisoners in Department of Correction custody who have Hepatitis C; b. Issue a judgment against defendants, declaring that their acts, omissions, policies, and practices with regard to the treatment of Hepatitis C are cruel and unusual punishment in violation of the Eighth and Fourteenth Amendments to the United States Constitution and 42 U.S.C. § 1983;
c. Issue preliminary and permanent injunctions ordering defendants to implement and adhere to a comprehensive treatment protocol that includes timely and adequate screening of DOC prisoners, timely evaluation, staging, and monitoring of Hepatitis C prisoners, timely treatment with the most effective medications, timely and adequate treatment of side effects to ensure that the Hepatitis C treatment is successful, and elimination of unjustified exclusions from or denials of treatment;
d. Enjoin defendants from taking any action to interfere with plaintiffs’ right to maintain this action, or from retaliating in any way against plaintiffs for bringing this action;
e. Award plaintiffs their reasonable attorneys’ fees and costs, in accordance with 42 U.S.C. § 1988 and other applicable law;
f. Grant such other and further relief as this Court considers just and proper.
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Dated: June 10, 2015

Respectfully submitted,
Plaintiffs Emilian Paszko and Jeffrey Fowler, on behalf of themselves and all others similarly situated,
By their Attorneys,
/s/ Jonathan Shapiro Jonathan Shapiro, BBO #454220 jshapiro@swglegal.com David Kelston, BBO #267310 dkelston@swglegal.com Shapiro Weissberg & Garin LLP 90 Canal Street Boston, MA 02114 (617) 742-5800, ext. 115
Cooperating Attorneys National Lawyers Guild Massachusetts Chapter, Inc.
/s/ Joel H. Thompson Joel H. Thompson, BBO #662164 jthompson@plsma.org Prisoners’ Legal Services 10 Winthrop Square, 3rd Flr. Boston, MA 02110 (617) 482-2773, ext. 102

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 Case 1:15-cv-12298-NMG Document 34 Filed 05/16/16 Page 1 of 2

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

JEFFREY FOWLER, PAUL WHOOTEN, MICHAEL TURNER, and MICHAEL FITZPATRICK, on behalf of themselves and all others similarly situated,
Plaintiffs,
v.
THOMAS TURCO, Commissioner of Massachusetts Department of Correction, in his official capacity, and MASSACHUSETTS PARTNERSHIP FOR CORRECTIONAL HEALTHCARE, INC.,
Defendants.

C.A. NO. 1:15CV12298

PLAINTIFFS’ MOTION FOR CLASS CERTIFICATION Now come Plaintiffs Jeffrey Fowler, Paul Whooten, Michael Turner, and Michael Fitzpatrick, through undersigned counsel, and seek certification pursuant to Fed. R. Civ. P. 23 of a class of all people who are or will be prisoners in the custody of the Massachusetts Department of Correction (“DOC”), and who have or will have Hepatitis C while in custody and have not yet been cured. The proposed class, in this action seeking declaratory and injunctive relief, satisfies the prerequisites of Rule 23(a) and (b). For the reasons stated in the memorandum and exhibits accompanying this motion, Plaintiffs respectfully request that the Court grant this motion and certify the proposed class, appointing the undersigned counsel as class counsel under Fed. R.

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Civ. P. 23(g). If the Court does not now certify a class, Plaintiffs request that it order class
discovery.
Plaintiffs, by their attorneys,
/s/ Joel H. Thompson Jonathan Shapiro, BBO #454220 jshapiro@swglegal.com David Kelston, BBO #267310 dkelston@swglegal.com Shapiro Weissberg & Garin 90 Canal Street Boston, MA 02114 (617) 742-5800, ext. 115
Joel H. Thompson, BBO #662164 jthompson@plsma.org Prisoners’ Legal Services 10 Winthrop Square, 3rd Flr. Boston, MA 02110 (617) 482-2773, ext. 102
CERTIFICATE OF SERVICE I hereby certify that this document filed through the ECF system will be sent
electronically to the registered participants as identified on the Notice of Electronic Filing (NEF)
and paper copies will be sent to those indicated as non-registered participants on May 16, 2016.
/s/ Joel H. Thompson Joel H. Thompson
CERTIFICATE OF COMPLIANCE WITH LOCAL RULE 7.1 I hereby certify that I have conferred with counsel for the Defendants in a good-faith
attempt to resolve this issue.
/s/ Joel H. Thompson Joel H. Thompson
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UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

JEFFREY FOWLER, PAUL WHOOTEN, MICHAEL TURNER, and MICHAEL FITZPATRICK, on behalf of themselves and all others similarly situated,
Plaintiffs,
v.
THOMAS TURCO, Commissioner of Massachusetts Department of Correction, in his official capacity, and MASSACHUSETTS PARTNERSHIP FOR CORRECTIONAL HEALTHCARE, INC.,
Defendants.

C.A. NO. 1:15CV12298

MEMORANDUM IN SUPPORT OF PLAINTIFFS¶ MOTION FOR CLASS CERTIFICATION INTRODUCTION
Plaintiffs Jeffrey Fowler, Paul Whooten, Michael Turner, and Michael Fitzpatrick seek certification of a class of all people who are or will be prisoners in the custody of the Massachusetts Department of Correction (! DOC" ), and who have or will have Hepatitis C while in custody and have not yet been cured. Through their policies and practices, the DOC and its medical contractor, Massachusetts Partnership for Correctional HealthCare, Inc., (! MPCH" ), are depriving prisoners with Hepatitis C of a cure for this virus that kills more people annually in the United States than the next sixty infectious diseases combined. Liver disease and its complications, up to and including death, can be avoided with timely treatment. The cost of surveilling for and treating complications from liver disease can also be avoided. Treatment with the current generation of Hepatitis C medications is simpler, shorter, and generates fewer side

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effects than ever before, with near perfect cure rates. Nevertheless, Defendants deny and delay treatment, putting these prisoners at substantial risk of harm.
The acts and omissions of Defendants with respect to Hepatitis C violate the Plaintiffs# and putative class members# rights under the Eighth Amendment to the United States Constitution. To remedy this violation, Plaintiffs seek a declaration that Defendants# policies and practices with regard to Hepatitis C are unlawful, and a permanent injunction requiring Defendants to implement and adhere to a timely and effective treatment protocol for Hepatitis C. As the central issue presented by Plaintiffs is common to all putative class members, who number over 1,500, and cannot practicably be addressed through piecemeal litigation, this Court should certify a class pursuant to Federal Rule of Civil Procedure 23(a) and 23(b)(2), of all current and future DOC prisoners who have or will have Hepatitis C and have not yet been cured.
BACKGROUND I. Hepatitis C in the Community.
Hepatitis C is a blood borne disease caused by a virus that brings about inflammation that damages the liver. It is a leading cause of liver disease and liver transplants. Hepatitis C is responsible for more deaths in the United States than the next sixty most common infectious diseases combined.1 In Massachusetts, Hepatitis C was once most prevalent among baby boomers. In recent years, however, a second peak has emerged with young adults.2 This new
1 Centers for Disease Control and Prevention, Hepatitis C Kills More Americans Than Any Other Infectious Disease, available at http://www.cdc.gov/media/releases/2016/p0504-hepc-mortality.html (last visited May 14, 2016). 2 Bureau of Infectious Disease, Mass. Dep# t of Public Health, Hepatitis C Virus Infection 2015 Surveillance Report, available at http://www.mass.gov/eohhs/docs/dph/cdc/reporting/surveillance-report-hepatitis-c.pdf (last visited May 14, 2016) at p. 13 (displaying age breakdown of new Hepatitis C cases in 2014, compared to 2007).
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spike has been fueled in large part by the state# s opioid crisis, since the virus is most commonly spread by intravenous drug use.3
Treatment for Hepatitis C has evolved over time. For years, the standard treatment was a combination of two drugs: Pegylated Interferon and Ribavirin. This combination therapy took 48 weeks to administer, it had the potential for serious side effects (including thrombocytopenia and depression), and it was not guaranteed to work, particularly for patients with Genotype 1, the most common genotype of Hepatitis C in the United States. See Ex. 1 (MPCH Clinical Guidelines: Evaluation and Treatment of Hepatitis C and Cirrhosis (July 1, 2013)) at 6 (combination therapy had 40-45% response rate for Genotype 1).
In 2011, the FDA approved two new protease inhibitors which, when either one was taken alongside combination therapy, produced better results $ an up to 80% cure rate for Genotype 1. Id. This ! triple therapy" became the new standard of care. Moreover, triple therapy even cured many of the patients who had previously tried combination therapy and were unsuccessful. Until the advent of triple therapy, these nonresponders or relapsers had no further treatment options.4
In November and December 2013, the FDA approved two new direct-acting antiviral medications, Sovaldi and Olysio.5 Either medication could be taken with combination therapy, and they could also be used together without combination therapy. The direct-acting antivirals
3 Bureau of Infectious Disease, Mass. Dep# t of Public Health, Shifting Epidemics: HIV and Hepatitis C Infection among Injection Drug Users in Massachusetts, available at http://www.mass.gov/eohhs/docs/dph/aids/shiftingepidemics-report.pdf (last visited May 14, 2016) at p. 1. 4 See, e.g., Gara, Naveen and Marc Ghany, ! The New Standard of HCV Therapy: Retreatment in Experienced Patients," Clinical Liver Disease, Vol. 1, No. 1 (AASLD February 2012), available at http://onlinelibrary.wiley.com/store/10.1002/cld.4/asset/4_ftp.pdf;jsessionid=C23561D420F9C28CAA3445886B6B 9DA8.f03t04?v=1&t=io9db8xl&s=8d6299e4b407cbfea6f210f31e5ab13e886a8167) (last visited May 15, 2016), at 16-19. 5 See U.S. Food and Drug Administration, ! FDA approves Sovaldi for chronic Hepatitis C," available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377888.htm (last visited May 15, 2016).
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improved outcomes considerably.6 On October 10, 2014, the FDA approved Harvoni, a one-pill regimen that combined Sovaldi with another medication to create an Interferon-free regimen, one with a cure rate well over ninety percent.7 On December 19, 2014, the FDA approved Viekira Pak, a multiple-pill regimen that was also Interferon-free and highly effective.8
These Interferon-free regimens9 marked a major advance in Hepatitis C treatment. They have an outstanding cure rate for every genotype, especially Genotype 1. They work on patients who had failed previous treatments. See Ex. 2 (AASLD and IDSA, ! Retreatment of persons in whom prior therapy has failed," in HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C (last modified April 25, 2016)). They pose far less risk of significant side effects, and the standard duration of treatment has dropped from 48 weeks under combination or triple therapy, to twelve weeks with the new regimens. Id.
With this significant advance came significant changes in the standard of care for Hepatitis C. Previously, both patient and provider weighed the possible benefits of treatment against potential drawbacks, including the possibility of treatment failure or relapse, and the potential for bad side effects. It was standard practice for providers to try to assess patients# fibrosis level $ the amount of scarring in their liver $ before deciding whether to recommend treatment. The assessment was typically made by liver biopsy, and the results of that biopsy, along with the patient# s other symptoms or complicating conditions, would inform the decision
6 Centers for Disease Control and Prevention, ! What is the treatment for chronic Hepatitis C?" HCV FAQs for Health Professionals, available at http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm#d3 (last visited May 15, 2016) (8095% cure rate). 7 U.S. Food & Drug Administration, FDA approves first combination pill to treat hepatitis C, available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418365.htm (last visited May 15, 2016). 8 U.S. Food & Drug Administration, FDA approves Viekira Pak to treat hepatitis C, available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427530.htm (last visited May 15, 2016). 9 They now also include Zepatier, a drug approved by the FDA in early 2016. U.S. Food & Drug Administration, FDA approves Zepatier for treatment of chronic Hepatitis C genotypes 1 and 4, available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm483828.htm (last visited May 15, 2016).
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of whether to undergo treatment. That decision was also informed by the possibility of new
medications emerging $ medications that would offer improved cure rates and fewer burdens.
Those new medications are here, with near-perfect cure rates, minimal side effects, and
shorter treatment durations. The American Association for the Study of Liver Diseases
(AASLD) and the Infectious Diseases Society of America (IDSA) have issued guidelines for the
treatment of Hepatitis C, modifying those guidelines in real time as new information becomes
available. See www.hcvguidelines.org. The guidelines now call for the treatment of everyone
with chronic Hepatitis C. See Ex. 3 (AASLD and IDSA, ! When and in whom to initiate HCV
therapy," in HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis
C (last updated February 24, 2016)) (! Treatment is recommended for all patients with chronic
HCV infection, except those with short life expectancies that cannot be remediated by treating HCV, by transplantation, or by other directed therapy" ).10
II. Hepatitis C Treatment in the DOC
Hepatitis C is highly prevalent in prisons. As combination therapy emerged in the early
2000s, the Massachusetts Department of Correction convened a task force to address diagnosis,
evaluation and treatment of Hepatitis C within the state prison system. Ultimately, the DOC and
10 The guidelines initially distinguished between patients based on their severity of disease, but the expert panel removed that provision, writing:
When the US Food and Drug Administration (FDA) approved the first IFN-sparing treatment for HCV infection, many patients who had previously been ! warehoused" sought treatment, and the infrastructure (experienced practitioners, budgeted health-care dollars, etc.) did not yet exist to treat all patients immediately. Thus, the panel offered guidance for prioritizing treatment first to those with the greatest need. Since that time, there have been opportunities to treat many of the highest-risk patients and to accumulate real-world experience of the tolerability and safety of newer HCV medications. More importantly, from a medical standpoint, data continue to accumulate that demonstrate the many benefits, within the liver and extrahepatic, that accompany HCV eradication. Therefore, the panel continues to recommend treatment for all patients with chronic HCV infection, except those with short life expectancies that cannot be remediated by treating HCV, by transplantation, or by other directed therapy. Id.
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its then-medical contractor implemented a protocol in which treatment was rationed. Ex. 4 (Carpenter, Kathyrn and Danielle Sorenson, The Management of Hepatitis C Treatment in Massachusetts State Correctional Facilities (Worcester Polytechnic Institute April 26, 2007)) at 11-12. Prisoners with Hepatitis C were deemed eligible for treatment based on their liver fibrosis stage, and other complications of the illness or other co-morbidities (such as HIV). Id. A prisoner deemed eligible for treatment was then placed on a wait list. The DOC and its contractor then treated prisoners with combination therapy, in batches of ten. Id.
The DOC set a maximum number of treatment slots, id., and closely monitored spending on Hepatitis C treatment, with combination therapy having a stand-alone line item in monthly pharmacy spending reports. See Ex. 5 (DOC pharmacy summary reports for FY09 $ FY15). At its most recent high point there were 95 or 96 treatment slots, see Ex. 4 at 11, Ex. 6 (2010 DOC contract amendment) at Attachment C, though on average only 81 patients were being treated at any given time. Ex. 5 at p. 1 (FY09 average of 81 ! Inmates on Rebetron/Pegintron" ). The number of prisoners receiving combination therapy subsequently declined steadily, over a period of years. Ex. 5 (FY10 $ FY14 pharmacy reports); Ex. 6 at Attachment C (reducing ! treatment cap" to 70). By Fiscal Year 2014, the average number of prisoners being treated in a given month was sixteen, out of a prison population of over 10,000. Ex. 5 at 6.
Well before triple therapy supplanted combination therapy as the new standard of care, the Hepatitis C task force was reconvened. Ex. 7 (February 11, 2009 email from Patti Onorato). The imminent arrival of triple therapy, and of the direct-acting antivirals beyond that, were known and contemplated well before their FDA approval. See Ex. 8 (March 3, 2011 DOC Pharmacy & Therapeutics Committee minutes) at 5 (presentation made regarding medications ! in late-phase development for use in Hepatitis C" ). The then-medical contractor for DOC had
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proposed a significant increase in commitment to treatment, Ex. 9 (excerpt from MGT of America, Inc., Analysis of Health Care Costs in the DOC (December 2011)) at 80, but when triple therapy arrived it was not made available in the DOC. See Ex. 10 (April 13, 2012 letter from Joel Thompson to Gov. Deval Patrick et al.); Ex. 11 (July 2, 2012 letter from Lawrence Weiner to Joel Thompson). It was not introduced into the DOC until 2013, see Ex. 12 (excerpt of June 2013 nonformulary medication report, reflecting orders for Boceprevir), by which time the DOC was treating fewer and fewer prisoners, and the direct-acting antivirals were approved by the FDA shortly thereafter, rendering triple therapy obsolete. See Ex. 5 at 5-6 (declining number of inmates on Hepatitis C medications through FY13 and FY14).
Treatment has remained out of reach for almost all DOC prisoners with Hepatitis C. The Pharmacy & Therapeutics Committee acknowledged the arrival of new medications, but for months it postponed any rollout. Compare Ex. 13 (April 2014 P&T minutes: ! guidelines are under development) with Ex. 14 (August 2014: ! 3 patients have been evaluated and cleared to start [Sovaldi] therapy in August" ) and Ex. 15 (October 2014: five patients evaluated and cleared to begin ! once operational processes are put into place" ). It was October 2014 when the first DOC prisoner received one of the new medicines, Sovaldi, which he took with the old combination therapy. Ex. 16 (December 2014 P&T Committee minutes) at 2. As of February 2015, only three prisoners were receiving Hepatitis C treatment. Ex. 5 at 7.
The available treatment for Hepatitis C has become almost 100% effective, requires no Interferon, can be taken orally for a much shorter duration, and involves no major side effects, but Defendants are delaying and denying treatment for virtually everyone. This practice contrasts sharply with the AASLD/IDSA guidelines, which call for the treatment of virtually everyone with Hepatitis C.
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III. Emilian Paszko. Originally a Plaintiff in this action, Emilian Paszko died of complications from Hepatitis
C on December 14, 2015. In late 2013, as Sovaldi and Olysio were obtaining FDA approval, Mr. Paszko was suffering from decompensated cirrhosis, portal hypertension, esophageal varices, and ascites. See Ex. 17 (selected medical records of Emilian Paszko). In the two years that followed, Mr. Paszko required multiple hospitalizations. The gastroenterologists who treated him discussed Hepatitis C treatment. As early as April 2014, a specialist noted that ! at this time he is not a good candidate for the antiviral therapy that is currently available." Id. at 6 (emphasis added). In June, another hospital provider stated that ! given his advanced liver disease, he is a good candidate at this time for direct-acting antivirals." Id. at 8. In November of 2014, after the arrival of Harvoni, the gastroenterology service noted that ! the newest therapies are not approved in the DOC system at this point in time; although, the patient would certainly be a candidate for consideration of therapy once these are approved." Id. at 12. In the ensuing months, Mr. Paszko saw the gastroenterology service several more times and was hospitalized again, but there was no movement toward Hepatitis C treatment. Id. at 14-47. Finally, at an August 3, 2015 video appointment, a gastroenterologist concluded that Mr. Paszko was too sick for treatment and that a liver transplant was the primary treatment. Id. at 49.
Mr. Paszko was exceedingly well known to Defendants and to the specialists at Lemuel Shattuck Hospital who treated him. He should have been evaluated for Hepatitis C treatment as soon as the direct-acting antivirals became available; his specialist providers confirmed that he was a good candidate for such treatment. Instead, Defendants allowed 20 months to pass before having him evaluated for treatment, at which point it was thought to be too late.
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IV. Jeffrey Fowler. Plaintiff Jeffrey Fowler has had Hepatitis C, genotype 1a, for over 25 years. Ex. 18
(Fowler Affidavit) at ¶ 1. A nonresponder to combination therapy, Mr. Fowler was approved by MPCH for triple therapy in 2014. Unfortunately, he was a nonresponder to triple therapy also, and he suffered from serious side effects during the treatment. Id. ¶¶ 3-8. Mr. Fowler believed and was told that given his history and the previously approved attempts to treat him, he would be a high priority for treatment with one of the Interferon-free regimens. Id. ¶ 9. For almost two years, however, he has been waiting, with MPCH refusing to consider him for treatment based in part on a prior liver biopsy $ a biopsy that preceded his triple therapy treatment. Id. ¶ 10. Mr. Fowler now has abdominal pain, and lab tests suggesting that his condition has become markedly worse; he was told that he is now recommended for treatment. But Mr. Fowler has no idea whether MPCH has or will approve treatment, or when. Id. at ¶ 14. V. Paul Whooten.
Plaintiff Paul Whooten has Hepatitis C and failed combination therapy treatment in the 2000s. Ex. 19 (Whooten Affidavit) at ¶¶ 2-4. He has sought to be treated again since entering DOC custody in 2011. He has been deemed ineligible for treatment first because of his pretrial status, then because he had spent less than a year as a sentenced prisoner in DOC (despite the fact that he had spent the previous two years in DOC custody as a pretrial detainee). Id. at ¶¶ 57. Mr. Whooten has now been a sentenced prisoner for more than a year, but he has not been considered for treatment nor even had a gastroenterology consult. Id. ¶ 8. VI. Michael Turner.
Plaintiff Michael Turner has Hepatitis C, is in DOC custody, and will remain so until he is released in 2021 or 2022, unless he is paroled before then. Ex. 20 at ¶¶ 1-2. Mr. Turner was
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treated with combination therapy while in the DOC, in 2012, but the treatment was stopped as it was not working and was causing serious side effects. Id. ¶ 5. Mr. Turner sought retreatment and spoke with MPCH providers about seeking triple therapy or waiting for Interferon-free regimens to arrive. He agreed to wait. Id. at ¶ 6.
Accordingly, in November of 2014 (after FDA approval of Harvoni) Mr. Turner sought treatment. At that point, MPCH deemed him ineligible for treatment, suggesting that his liver function was normal, notwithstanding his previous evaluation and treatment approval years before. Id. at ¶ 7. Mr. Turner continued to be found ineligible until September 2015, when he saw a gastroenterologist. Id. at ¶ 9. That specialist told Mr. Turner that he was approved for treatment and would start medications in the following week. Id. Nevertheless, Mr. Turner has not begun Hepatitis C treatment; MPCH has told him that he is on a waiting list and is a ! lower priority" patient. Id. at ¶ 10. Blood tests taken in January 2016 suggest that Mr. Turner now has stage F4 liver fibrosis. Id. at ¶ 11. VII. Michael Fitzpatrick.
Plaintiff Michael Fitzpatrick is a DOC prisoner who is due to be released in September of this year. Ex. 21 at ¶ 1. He has Hepatitis C, genotype 1a, which has brought about cirrhosis of the liver, GAVE disease, and esophageal varices. Id. at ¶ 3. As early as April 2012, testing indicated cirrhosis, and a specialist recommended putting Mr. Fitzpatrick ! at the top of the list" for treatment. Id. at ¶ 5. A year later, Mr. Fitzpatrick was started on triple therapy, but he suffered from severe side effects that forced MPCH to discontinue treatment in July 2013. Id. at ¶¶ 6-7.
Unsurprisingly, as early as April 2014 a specialist recommended retreatment with directacting antivirals. The gastroenterologist recommended treatment with Sovaldi and Olysio (the
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only available Interferon-free regimen at that time, as Harvoni was not yet available). Id. at ¶ 8. Mr. Turner was not treated then. He was hospitalized on several occasions, where doctors found evidence of portal hypertension, splenomegaly, esophageal varices, and GAVE disease. Mr. Fitzpatrick frequently found himself coughing up blood and/or with blood in his stool. Id. at ¶¶ 9-10, 12-14.
MPCH declared Mr. Fitzpatrick ineligible for treatment in April 2015, for twelve months, because he had been issued a disciplinary report for possession of homebrew. Id. at ¶ 11. Notwithstanding the fact that he was previously recognized as a high-priority patient, and that he has suffered from serious complications of his Hepatitis C, he still awaits treatment. Id. at ¶ 15. Although MPCH# s period of ineligibility should have lifted, he apparently falls within MPCH# s exclusion of treatment for prisoners too close to their release date. See Ex. 1 at 4-5.
PROPOSED CLASS DEFINITION All people who are or will be prisoners in the custody of the Massachusetts Department of Correction (! DOC" ), who have or will have Hepatitis C and have not yet been cured.
ARGUMENT Federal Rule of Civil Procedure 23(a) contains four ! prerequisites" for class certification. If those prerequisites are met, and if the case also falls within one of the ! types" of class actions described in Rule 23(b), then the plaintiffs ! are entitl[ed]% to pursue [their] claim as a class action." Shady Grove Orthopedic Assocs., P.A. v. Allstate Ins. Co., 559 U.S. 393, 398 (2010). In the present case, those conditions are satisfied. I. The Proposed Class Satisfies the Four Prerequisites of Fed. R. Civ. P. 23(a). The four prerequisites required under Fed. R. Civ. P. 23(a) are known as numerosity, commonality, typicality, and adequacy. First, the class must be ! so numerous that joinder of all
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members is impracticable." Fed. R. Civ. P. 23(a)(1). Second, there must be ! questions of law or
fact common to the class." Fed. R. Civ. P. 23(a)(2). Third, the claims of the representative
plaintiffs must be ! typical of the claims or defenses of the class." Fed. R. Civ. P. 23(a)(3).
Finally, the representative plaintiffs must ! fairly and adequately protect the interests of the
class." Fed. R. Civ. P. 23(a)(4).
A. Numerosity. The proposed class is so numerous that joinder of all members is impracticable. See Fed.
R. Civ. P. 23(a)(1). According to information obtained via a public records request, as of
January 2015, there were 1,560 prisoners in its custody known to have Hepatitis C, out of 10,379
total prisoners. Exhibit 22 (March 5, 2015 P&T Committee minutes) at 2, 1. A high enough
number is itself sufficient to render joinder impracticable, and in the First Circuit, the number is
generally forty. Reid v. Donelan, 297 F. R. D. 185 (D. Mass 2014); George v. Nat’l Water Main
Cleaning Co., 286 F.R.D. 168, 173 (D. Mass. 2012). See also Scott v. Clarke, 61 F.Supp.3d 569,
584 (W.D.Va. 2014) (certifying class s of 1,200 prisoners claiming inadequate medical care).
The acknowledged number of DOC prisoners with Hepatitis C more than suffices to establish numerosity.11
11 Sheer numbers aside, the turnover in the DOC prison population also satisfies Rule 23(a)(1). Courts consider the transient membership in the proposed class to determine ! the difficulty or inconvenience of joining all members of the class." George, 286 F.R.D. at 173 (quoting Advertising Specialty Nat’l Ass’n v. Fed. Trade Comm’n, 238 F.R.D. 108, 119 (1st Cir. 1956)). Here, the transient nature of the DOC population makes joinder impracticable: ! [u]nforeseen members will join the class at indeterminate points in the future, making joinder impossible." Reid, 297 F.R.D. at 189. Cases involving transient commitment or incarcerated populations are particularly well-suited to class certification because ! the inmate population % is constantly revolving." Green v. Johnson, 513 F.Supp. 965, 975 (D.Mass. 1981). See also J.D. v. Nagin, 255 F.R.D. 406, 414 (E.D.La. 2009) (! [t]he mere fact that the population of the [detention center] is constantly revolving during the pendency of litigation renders any joinder impracticable" ); Gordon v. Johnson, 300 F.R.D. 31, 36 (D.Mass. 2014); Hawker v. Consovoy, 198 F.R.D. 619, 625 (D.N.J. 2001); Williams v. Conway, No. 9:15-cv-427, 2016 WL 65064, at *3 (N.D.N.Y. Jan. 4, 2016) (! the class action device is particularly well-suited in actions brought by prisoners due to the & fluid# composition of the prison population% [and] generally tend[s] to be the norm in actions such as this" (internal quotation marks and citation omitted)) (quoting Clarkson v. Coughlin, 783 F. Supp. 789, 797 (S.D.N.Y. 1992)); Scott, 61 F.Supp.3d at 584.
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B. Commonality. There are clearly ! questions of law or fact common to the class." Fed. R. Civ. P. 23(a)(2). Commonality exists when plaintiffs ! demonstrate that the class claims & depend upon a common contention# and that determining the truth or falsity of that contention & will resolve an issue that is central to the validity of each one of the claims in one stroke.# " Connor B., ex rel. Vigurs v. Patrick, 278 F.R.D. 30, 32 (D. Mass. 2011) (quoting Wal-Mart Stores, Inc. v. Dukes, 131 S.Ct. 2541, 2551 (2011)). ! Even a single common question" is sufficient to satisfy Rule 23(a)(2). Wal-Mart, 131 S.Ct. at 2556 (internal quotations and citations omitted). This case presents common questions central to the validity of the putative class# claims, which include, but are not limited to: a. whether treatment for Hepatitis C is a serious medical need; b. whether Defendants have knowingly failed to provide the necessary staging $ the
testing needed to determine the severity of the disease $ of Hepatitis C-positive prisoners; c. whether Defendants have knowingly failed to provide the most effective and appropriate treatment for Hepatitis C; d. whether Defendants have knowingly employed policies and practices that unjustifiably delay or deny treatment for Hepatitis C; e. whether Defendants# failures have placed Hepatitis C-positive prisoners at risk of suffering a deterioration in health, new ailments, worsening of existing ailments, and the prospect of premature or unnecessary disability or death; and
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f. whether Defendants# policies and practices reflect deliberate indifference to the serious medical needs of the class members, in violation of their right to be free from cruel and unusual punishment.
The central issues presented by this case are ! capable of class-wide resolution" in ! one stroke." Wal-Mart, 131 S.Ct. at 2551. The proposed class thus ! ha[s] common interest in the disposition of the disputed questions of law," Banner v. Smolenski, 315 F.Supp. 1076, 1080 (D. Mass. 1970), and this class action will generate common answers. See Wal-mart, 131 S.Ct. at 2551 (citations omitted). Additionally, the central legal issues arise from facts common to all class members. Every class member has been subjected to or is at imminent risk of suffering the same rights violations by the Defendants, as a result of the same policies and practices.
Any factual differences that may exist among class members in terms of their individual medical condition cannot defeat this commonality. The key questions do not revolve around each prisoner# s particular plight, but the Defendants# systemic deficiencies in treating Hepatitis C. ! Plaintiffs have alleged specific and overarching systemic deficiencies" on the part of the DOC and its medical contractor; ! [t]hese systemic shortcomings provide the & glue# that unites Plaintiffs# claims." Connor B., 278 F.R.D. at 34. Courts elsewhere have similarly found the commonality requirement satisfied in claims regarding inadequate prison health care. See, e.g., Scott, 61 F.Supp.3d at 584-87 (whether defendants# policies and practices place current and future prisoners at substantial risk of serious harm, to which defendants are deliberately indifferent, implicates common questions of fact and law), 587-88 (citing other post-Wal-Mart decisions finding commonality in prisoner class actions challenging unconstitutional conditions of confinement); Parsons v. Ryan, 754 F.3d 657, 675-85 (9th Cir. 2014). Plaintiffs, therefore, satisfy the commonality requirement.
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C. Typicality. Plaintiffs# claims are typical of those of the proposed class. See Fed. R. Civ. P. 23(a)(3). Although the ! claims of the entire class need not be identical," the class representatives ! must generally & possess the same interests and suffer the same injury# as the unnamed class members." Gen. Tel. Co. of Sw. v. Falcon, 457 U.S. 147, at 156 (1982) (citations omitted). Representative plaintiffs can show typicality by ! demonstrating that [their] injuries arise from the same course of conduct as the rest of the class, and that [their] claims are based on the same legal theory as those of the class." Glass Dimensions, Inc. v. State St. Bank & Trust Co., 285 F.R.D. 169, 178 (D. Mass. 2012). ! Typicality & is designed to align the interests of the class and the class representatives so that the latter will work to benefit the entire class through the pursuit of their own goals." Glass Dimensions, 285 F.R.D. at 178 (citation omitted). Plaintiffs and members of the proposed class are, or will be, subjected to the same challenged policies, practices, and harms by the Defendants. Like all other members of the class, Plaintiffs have Hepatitis C. They have not been treated with the available medication that is nearly one hundred percent curative, with minimal side effects. They are being subjected to the same policies and practices surrounding Hepatitis C treatment, policies and practices that place them at risk of serious harm from untreated Hepatitis C, including cirrhosis, liver cancer, and other complications from end stage liver disease.12 In addition, as specified in the Complaint, Plaintiffs seek declaratory and injunctive relief based on the same legal theories that would provide relief to the rest of the proposed class.
12 It does not matter that they may have suffered different complications or symptoms, or that they are at different stages of their disease progression. The fact that Plaintiffs# harm ! may differ in some respects from those suffered by unnamed Plaintiffs does not undermine typicality." Connor B. ex rel. Vigurs v. Patrick, 272 F.R.D. 288, 296-97 (D. Mass. 2011) (citations omitted). Indeed, as with commonality, it is ! [b]ecause Plaintiffs have identified specific systemic failures that expose the entire Plaintiff class" to rights violations and an unreasonable risk of additional harms that ! the typicality requirement is satisfied." Connor B., 272 F.R.D. at 297; Williams, 2016 WL 65064, at *5. Other courts have found likewise in cases challenging the adequacy of prison health care. See Parsons, 754 F.3d at 685-86; Scott, 61 F.Supp.3d at 589-90.
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Accordingly, ! no possibility exists that an individual claim or factual difference will & consume the merits# of this class action." Reid v. Donelan, 297 F.R.D. 185, 191 (D. Mass. 2014). Plaintiffs, therefore, satisfy the typicality requirement.
D. Adequacy. Finally, Plaintiffs will ! fairly and adequately protect the interests of the class." Fed. R. Civ. P. 23(a)(4). To satisfy this requirement, Plaintiffs must ! & first show that the interests of the representative party will not conflict with the interests of any of the class members, and second, that counsel chosen by the representative party is qualified, experienced, and able to vigorously conduct the proposed litigation." Reid, 297 F.R.D. at 191 (quoting Andrews v. Bechtel Power Corp., 780 F.2d 124, 130 (1st Cir. 1985)). With respect to class counsel, courts must consider ! (i) the work counsel has done in identifying or investigating potential claims in the action; (ii) counsel# s experience in handling class actions, other complex litigation, and the types of claims asserted in the action; (iii) counsel# s knowledge of the applicable law; and (iv) the resources that counsel will commit to representing the class." Fed. R. Civ. P. 23(g). Courts can also consider ! any other matter pertinent to counsel# s ability to fairly and adequately represent the interests of the class." Id. Plaintiffs# interests are consistent with, and are ! not antagonistic to or in conflict with" the interests of the proposed class as a whole. Connor B., 272 F.R.D. at 297. The requested declaratory and injunctive relief will apply equally to and benefit all class members. Plaintiffs are not seeking damages or any other limited resource that could yield conflicts. Because ! every member is seeking the same remedy% based on an identical theory% Plaintiffs# interests are coextensive with the class." Reid, 297 F.R.D. at 191.
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Moreover, Plaintiffs have retained experienced and competent counsel who will fairly and adequately protect the interests of the proposed class. Plaintiffs are represented by Prisoners# Legal Services (! PLS" ) and the law firm Shapiro, Weissberg & Garin (! SWG" ), on behalf of the National Lawyers Guild.
PLS is a not-for-profit legal services corporation established in 1972 to promote the safe, humane and lawful treatment of Massachusetts prisoners. It has litigated numerous complex civil rights class actions, and civil rights actions addressing prison health care, and is experienced in the protection of the statutory and constitutional rights of prisoners. See, e.g., Souza v. Sheriff of Bristol County, 455 Mass. 573 (2010); Haverty v. Comm’r of Correction, 440 Mass. 1 (2003); Nunes v. Mass. Dep’t of Correction, 766 F.3d 136 (1st Cir. 2014). SWG has substantial experience litigating class actions and civil rights actions, including prison cases. See, e.g., Ponte v. Real, 471 U.S. 491 (1985); Furtado v. Bishop, 604 F.2d 80 (1st Cir. 1979); Bl(a)ck Tea Society v. City of Boston, 378 F.3d 8 (1st Cir. 2004); Jews for Jesus, Inc. v. Mass. Bay Transportation Authority, 783 F.Supp. 1500 (D. Mass. 1991); Bentley v. Essex County, Essex Superior Court, Civ. No. 2011-1907.
Plaintiffs# counsel have already invested substantial time and resources in this case. Before filing suit, Plaintiffs# counsel communicated with, visited, reviewed records for, and advocated for multiple DOC prisoners with Hepatitis C; investigated the Defendants# policies and practices around Hepatitis C treatment; and researched potential claims. For over a decade, PLS has advocated for prisoners about Hepatitis C specifically, and it has investigated the DOC# s practices in treating this disease. See, e.g., Ex. 10. These efforts and others, together with the willingness of Plaintiffs# counsel ! to fund all costs of this litigation through trial,"
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ensure that members of the proposed class will be adequately represented. Connor B., 272 F.R.D. at 297. II. The Proposed Class Meets the Requirements of Fed. R. Civ. P. 23(b).
Plaintiffs also meet at least one of the requirements of Fed. R. Civ. P. 23(b). Specifically, Plaintiffs meet the requirements of Rule 23(b)(2), which permits class certification when the adverse party ! has acted or refused to act on grounds that apply generally to the class, so that the final injunctive relief or corresponding declaratory relief is appropriate respecting the class as a whole."
! The key to the (b)(2) class is the indivisible nature of the injunctive or declaratory remedy warranted $ the notion that the conduct is such that it can be enjoined or declared unlawful as to all of the class members or as to none of them." Wal-Mart, 131 S.Ct. at 2557 (internal quotations omitted); see also Yaffe v. Powers, 454 F.2d 1362, 1366 (1st Cir. 1972). This feature of Rule 23(b)(2) certification makes it ! uniquely suited to civil rights actions," Connor B., 272 F.R.D. at 297 (quoting Yaffe, 454 F.2d at 1366). ! [C]lass actions certified pursuant to Rule 23(b)(2) are particularly important in cases involving civil rights actions, specifically those related to hospital or prison reform," as class certification in such cases is ! crucial to ensure that the granted relief benefits all members of the class." Rolland v. Patrick, 2008 WL 4104488, at *6 (D. Mass. Aug. 19, 2008) (citations omitted). Courts routinely certify Rule 23(b)(2) class actions within these contexts, including claims for inadequate prison health care. See Smith v. Ashe, 106 F.R.D. 353, 354-55 (D. Mass. 1985) (certifying a 23(b)(2) class challenging conditions of confinement and medical treatment for prisoners segregated from general population); Parsons, 754 F.3d at 686-87 (certifying 23(b)(2) class challenging adequacy of all health care in state prison system); Scott, 61 F.Supp.3d 569 (certifying 23(b)(2) class
18

Case 1:15-cv-12298-NMG Document 35 Filed 05/16/16 Page 19 of 21
challenging adequacy of all health care in women# s prison); id. at 583 (citing other similar cases).
Rule 23(b)(2) certification is appropriate in this matter. Defendants have acted on grounds that generally apply to the entire class. The unlawful policies and practices of the Defendants, as well as the constitutional rights violations suffered by Plaintiffs as a result of Defendants# policies and practices, are substantially similar, if not identical, among members of the class. Furthermore, Plaintiffs seek declaratory and injunctive relief that ! would benefit the entire class." Connor B., 272 F.R.D. at 297; see Gordon, 300 F.R.D. at 38.
Additionally, cases brought by prisoners, like Plaintiffs, are well-suited to class action treatment, ! due to the & fluid composition# of the prison population." Clarkson v. Coughlin, 783 F. Supp. 789, 797 (S.D.N.Y. 1992) (quoting Dean v. Coughlin, 107 F.R.D. 331, 332 (S.D.N.Y. 1985)). Prisoners are released or transferred and new prisoners arrive every day, while the underlying claims tend to remain. Dean, 107 F.R.D. at 323-33; see also Henderson v. Thomas, 289 F.R.D. 506 (M.D. Ala. 2012) (certifying class of HIV-positive prisoners who alleged discrimination based on disability); Hernandez v. County of Monterey, 305 F.R.D. 132 (N.D. Cal. 2015) (certifying class of jail inmates who challenged health care and disability policies and practices).
Here, there is a danger of mootness based on the nature of the prison population and the risk that the Defendants may provide treatment to the named Plaintiffs in order to seek to resolve their individual issues, which will fail to resolve the systemic problems alleged. Similarly, there is a risk that a declaration of the rights of each named Plaintiff would not resolve the problems of the other class members because requiring the Defendants to fulfill their statutory and
19

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constitutional obligations as to several individuals will not provide a resolution for the alleged
systemic problems. Accordingly, Rule 23(b)(2) certification is proper.
III. In the Alternative, the Court Should Order Class Discovery. If, despite the above showing regarding the appropriateness of class certification, the
Court finds that the present record is not adequate to determine whether a class should be certified, Plaintiffs respectfully request that the Court order class discovery. See Yaffe, 454 F.2d
at 1367. Defendants are in possession of extensive information about members of the proposed
class, limited discovery of which would further demonstrate that class certification is proper.
CONCLUSION The proposed class satisfies the prerequisites of Fed. R. Civ. P. 23(a) and (b). Plaintiffs
respectfully request that this Court certify the proposed class of DOC prisoners with Hepatitis C
and appoint the undersigned counsel as class counsel under Fed. R. Civ. P. 23(g). If the Court
does not now certify a class, Plaintiffs request that it order class discovery.
Plaintiffs, by their attorneys, /s/ Joel H. Thompson Jonathan Shapiro, BBO #454220 jshapiro@swglegal.com David Kelston, BBO #267310 dkelston@swglegal.com Shapiro Weissberg & Garin 90 Canal Street Boston, MA 02114 (617) 742-5800, ext. 115
Joel H. Thompson, BBO #662164 jthompson@plsma.org Prisoners# Legal Services 10 Winthrop Square, 3rd Flr. Boston, MA 02110 (617) 482-2773, ext. 102
20

Case 1:15-cv-12298-NMG Document 35 Filed 05/16/16 Page 21 of 21 CERTIFICATE OF SERVICE
I hereby certify that this document filed through the ECF system will be sent electronically to the registered participants as identified on the Notice of Electronic Filing (NEF) and paper copies will be sent to those indicated as non-registered participants on May 16, 2016.
/s/ Joel H. Thompson Joel H. Thompson
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Date of MPCH Approval: Date of DOC Acknowledgment Effective Date:
Title & Date of Replaced Guideline:

7/1/13 7/1/13 7/1/13
N/A

MPCH Clinical Guidelines
Evaluation and Treatment of Hepatitis C and Cirrhosis 1. Introduction & Purpose
The Massachusetts Partnership for Health (MPCH) has adapted this guideline from the Federal Bureau of Prisons. The clinical practice guideline for Evaluation and Treatment of Hepatitis C and Cirrhosis provides recommendations for the medical management of Massachusetts Department of Correction inmates with Hepatitis C.
2. Transmission of Hepatitis C Virus
Hepatitis C virus (HCV) is a single-stranded, enveloped, RNA virus with multiple genotypes and subtypes. Genotype 1 is predominant in the United States. HCV is transmitted primarily by direct percutaneous exposures to infectious blood. Modes of transmission are summarized below in Table I.
Table 1. Modes of Transmission of Hepatitis C Virus
Percutaneous exposure to infectious blood (primary mode):
- Injection drug use - Transmission of contaminated blood products (prior to July 1992) - Tattooing with shared sharps in jails or prisons (potential mode)
Other modes of transmission (inefficient): - Sexual contact (increased risk for inmates with history of STD or multiple sexual partners) - Fighting, biting - Congenital transmission (risk of 5-6%)
Ways HCV is NOT transmitted: - Breast feeding - Kissing, sneezing, hugging, coughing - Food or water - Casual contact, including sharing eating utensils or drinking glasses
NOTE: Most inmates diagnosed with HCV infection have behavioral risk factors fin. acquiring HCV and were infected prior to incarceration. Low levels of HCV transmission between inmates have been documented via seroincidence studies and contact investigations. However, large HCV outbreaks have not been reported in the correctional setting.

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3. Acute Hepatitis C Infection
Diagnosis of Acute HCV Infection Acute HCV infection is diagnosed when there is circumstantial evidence of new infection (such as recent exposure to a known HCV-infected inmate) or the presence of clinical features of acute Hepatitis (jaundice, nausea, anorexia, and malaise), and where the other causes of Hepatitis have been excluded. Acute Hepatitis C rarely causes fulminant hepatic failure.
The mean incubation period, from transmission of HCV infection to the onset of symptoms, is 6-7 weeks (range: 2-26 weeks); however, only 20-30% of newly infected persons are actually symptomatic. Serum ALT levels increase 4-12 weeks after acute HCV infection. HCV RNA is detectable in serum within days to 8 weeks following infection. Antibodies to HCV (anti-HCV) are detectable 3 months after infection in 90% of inmates. A subset of those with acute HCV infection spontaneously clear the virus. Laboratory criteria for diagnosis of acute Hepatitis C are summarized below in Table 2.
Table 2. Laboratory Criteria forͻ Diagnosis ofAcute Hepatitis C Confirmation of acute Hepatitis C is confirmed by all of the following:
1. Marked elevation in ALT (>7 times the upper limit of normal, with or without symptoms of acute Hepatitis); and
2. Negative tests for acute Hepatitis A (IgM anti-HAV) and acute Hepatitis B (1gM anti-HBc); and
3. A positive anti-HCV screening immunoassay (enzyme immunoassay, EIA, or chemoluminescence immunoassay, CIA) that is confirmed with one of the following: - An immunoassay with a signal to cut-off ratio predictive of a true positive for that assay; or - An HCV RNA assay. (HCV RNA may be detected 1-3 weeks after exposure. However, viremia may be transient post-exposure, i.e., a negative HCV RNA does not rule out acute HCV infection.)
Treatment of Acute HCV Infection Inmates diagnosed with acute Hepatitis C should be considered for antiviral therapy, in consultation with a physician who has expertise in managing Hepatitis C. Treatment can be delayed for 8 to 12 weeks after acute onset of Hepatitis to allow for spontaneous resolution of the infection. The optimal duration of a treatment regimen for acute infection is unknown. It is reasonable to treat for at least 12 weeks; however, up to a total of 24 weeks may be considered. At treatment weeks 4 and 12, an HCV RNA assay should be obtained to assess the response to treatment. The components of treatment of Acute HCV infection are presented in Appendix I.
4. Chronic Hepatitis C Infection
Natural History of Chronic HCV Infection Most persons infected with HCV develop chronic infection; however, a small subset of newly infected persons are able to clear the virus spontaneously. Chronic HCV infection frequently results in high levels of HCV RNA in the blood, ranging from 105 to 107 international units (1U)/mL, despite the presence of HCV antibodies. The majority of persons with chronic HCV infection are asymptomatic. Chronic HCV infection has an unpredictable course, frequently characterized by fluctuations in ALT levels that may or may not be associated with significant liver disease. Approximately one-third of persons with chronic HCV infection have no laboratory or biopsy evidence of liver disease.
A small, but significant subset of persons with chronic HOT infection develop progressive fibrosis of the liver that leads to cirrhosis. Transfusion-acquired HCV, high levels of alcohol consumption, older age at the time of infection, HIV infection, chronic HBV infection, and male gender are associated with an increased risk of disease progression. However, neither the degree of viremia ("viral load") nor the HCV genotype affect the progression of liver disease. Other factors that
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appear to increase the risk of cirrhosis, and decrease the response to antiviral therapy, include: hepatic steatosis, marked necroinflammation on biopsy, and certain host immunologic characteristics. Once cirrhosis develops in persons with chronic HCV infection, the risk of hepatocellular carcinoma (FICC) is about 1-4% per year. HCV accounts for one-third of the cases of HCC in the U.S. each year.
Stepwise Approach for Detecting, Evaluating, and Treating Chronic Hepatitis C Current antiviral treatment for Hepatitis C has some limitations in terms of both efficacy and toxicity. With this in mind, MPCH has adopted a stepwise, systematic approach to Hepatitis C detection, evaluation, and treatment. Table 3 lists the ten steps in this process.

Table 3. Steps for Detecting, Evaluating, and Treating Chronic Hepatitis C

Step 1. Step 2. Step 3a.

Appropriately screen inmates for Hepatitis C. Provide initial medical follow-up for anti-HCV positive inmates. Determine if Hepatitis C treatment is not recommended.

Step 3b.

Monitor HCV-infected inmates who are not on treatment.

Step 4. Step 5. Step 6. Step 7.

For inmates who may be eligible for Hepatitis C treatment, proceed as follows: Obtain HCV RNA assay and HCV genotype. Assess liver fibrosis and need for a liver biopsy. Determine if treatment should be initiated. Conduct a pre-treatment evaluation.

Step 8. Step 9a.

Determine appropriate treatment and obtain informed consent. Manage side effects.

Step 9b.

Monitor treatment response.

Step 10.

Assess for sustained viral load (SVR).

Following is a discussion of steps 1 through 10 for detecting, evaluating and treating chronic HCV. The components of the steps are presented in Appendix 2.

Step 1. Appropriately screen inmates for Hepatitis C.
Inmate Education Appropriately trained personnel should provide newly incarcerated inmates with educational information on the transmission, natural history, and medical management of HCV infection, in accordance with MPCH policy. Available educational tools are referenced in Appendix 7.
Screening Criteria For sentenced inmates with Hepatitis C risk factors, screening is recommended at the initial health assessment. In addition, all inmates with certain clinical conditions should be screened for Hepatitis C, regardless of sentencing status. Appendix 2, Step 1 lists the risk factors and clinical indications that should trigger screening for Hepatitis C viral infection. Unless clinically indicated, screening should ordinarily not be pursued for asymptomatic, highly mobile, non-sentenced inmates. However, non-sentenced inmates who have a history of injection dnig use or other high-risk behaviors for HCV should be provided with counseling. Education should cover the risks for HCV infection, as well as behaviors that would reduce transmission of HCV infection during incarceration and upon release.
Screening Method The preferred screening test for HCV infection is an immunoassay (e.g., EIA or CIA) that measures antibodies to HCV antigens.

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Refusal of Testing
Sentenced inmates who have HCV risk factors Ͷ and refuse testing at the baseline visit Ͷ should be counseled about HCV testing during periodic preventive health visits.
Step 2. Provide initial medical follow-up for anti-HCV positive inmates.
Baseline Evaluation A baseline clinician evaluation should be conducted for all inmates who are anti-HCV positive. At minimum, this evaluation should include the following:
Targeted history and physical examination: Evaluate for signs and symptoms of liver disease, quantify prior alcohol consumption, and determine risk behaviors for acquiring HCV infection. Attempt to estimate and document the earliest possible date of infection, including when risk factors for exposures started and stopped, e.g., the time period in which the inmate engaged in injection drug use, Evaluate for other possible causes of liver disease, especially alcoholism, nonalcoholic steatohepatitis (NASH), iron overload, and autoimmune Hepatitis. Inquire about prior treatment for HCV infection, specific medications used, dosages and duration of treatment, and outcomes, if known.
Laboratory tests: Recommended baseline laboratory tests are listed in Appendix 3. However, until it is determined that an inmate is a potential candidate for treatment (see Steps 3a and 3b, below), do not obtain an HCV RNA, an HCV genotype, or a liver biopsy.
Inmate Education Inmates diagnosed with chronic HCV infection should be counseled by a health care provider regarding the natural history of the infection, potential treatment options, and specific measures to prevent transmitting HCV infection to others (both during incarceration and upon release). Sources for Hepatitis C educational materials are listed in Appendix 7.
Preventive Health Measures All inmates who are anti-HCV positive should be evaluated to assess the need for the preventive health interventions outlined in Appendix 2, Step 2.
Step 3a. Determine if Hepatitis C treatment is not recommended.
Next, determine if treatment for Hepatitis C is not recommended based on the following criteria:
I. Pegylated interferon is contraindicated. Inmates with chronic HCV infection who are being considered for antiviral therapy should first be assessed for contraindications to interferon, as listed in Appendix 2, Step 3a. Inmates with contraindications to interferon cannot be treated for Hepatitis C.
2. Ribavirin is contraindicated. Inmates with chronic HCV infection who are being considered for antiviral therapy should be assessed for contraindications to ribavirin, as listed in Appendix 2, Step 3a. Inmates with contraindications to ribavirin may not be treated for Hepatitis C.
3. Inmate will be incarcerated for an insufficient period of time to complete treatment. Inmates who are candidates for Hepatitis C treatment but whose anticipated length of stay will not allow sufficient time to complete therapy, should ordinarily not be started on antiviral therapy. This includes pre-trial and nonsentenced inmates, or inmates whose anticipated release date will not allow sufficient time to complete treatment.
The potential for interruption of antiviral therapy for Hepatitis C places an inmate at risk for a number of adverse outcomes, including treatment failure if the course of treatment is not completed and adverse effects from medications if the inmate does not receive the required laboratory and clinical monitoring upon release or transfer.
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MPCH anticipates the course of therapy to be 3.5 years for Genotype 1, 4, 5, 6. For Genotype 2 and 3, the anticipated course of therapy is 2.5 years.

Observation Evaluation
Treatment Follow-Up

Minimum of 12 Months Up To 12 Months
Up To 12 Months 6 Months

PCP to identify the inmate's social, medical and mental health concerns/issues, develop necessary treatment plans, and monitor compliance.
Initial specialty consult and labs to begin work-up. In-hospital liver biopsy procedure (if indicated). Follow-up specialty consultation to review results and outline treatment plan and dosage recommendations.
Up to 48 weeks of prescribed therapy.
Obtain SVR blood test which determines the "virologic cure" of the treatment 24 weeks after end of therapy, and provide appropriate follow-up (current practice).

NOTE: Inmates entering custody who are currently being treatedfbr Hepatitis C should be maintained on antiviral therapy (unless medically contraindicated). The process is outlined in Hepatitis C Medication Therapy Intake Worksheet (Form 8102).
In the event that an inmate is scheduled for release, a referral should be directed to MPCH Chief Coordinator of Reentry and Aftercare Services 90 days prior to release. A Discharge Planner will meet with the inmate, review the chart, and consult with HSU staff as needed. The Discharge Planner will then work with community health agencies, as well as obtain necessary releases and appropriate referrals will be made to provide continuity of care.
4. The inmate has an unstable medical or mental health condition which precludes Hepatitis C treatment, e.g., refractory HIV-infection with AIDS, uncontrolled diabetes mellitus, life-threatening COPD or CHF, or uncontrolled depression,
5. The inmate refuses treatment. Inmates should initially be provided with counseling about Hepatitis C treatment. If an inmate then refuses the possibility of treatment, the refusal should be documented in the medical record.
If any one of the above criteria are present, Hepatitis C treatment should not be pursued. Document in the medical record the reason Hepatitis C treatment is not currently recommended. No further Hepatitis C testing is indicated at this time, including HCV RNA testing, HCV genotyping, or liver biopsy. However, continue to monitor the inmate, as discussed in Step 3b.

Step 3b. Monitor HCV-infected inmates who are not on treatment.
HCV-infected inmates for whom treatment is not recommended should continue to be followed in chronic care clinic, and evaluated periodically to determine if Hepatitis C treatment should be reconsidered. Monitoring recommendations are outlined in Appendix 2, Step 3b.
For inmates who may be eligible for Hepatitis C treatment, proceed as follows:

Step 4. Obtain HCV RNA assay and HCV genotype.
HCV RNA The detection of anti-HCV by immunoassay in a person who has risk factors for acquiring HCV infection strongly suggests prior infection. However, before initiating antiviral therapy, an HCV RNA level (viral load) is required in order to confirm chronic infection and guide therapy. If the HCV RNA level is undetectable, the individual can be considered uninfected. Possible explanations include either host clearance of viremia or a "false-positive" immunoassay result.

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NOTES: 1. Strict adherence to current reference laboratory test processing guidelines for HCV RNA test samples is
essential; viral RNA is unstable, and false negative tests may result from inadequate or inappropriate processing.
2. For monitoring purposes, it is important to use the same laboratory test before and during therapy.
3. When treating with an HCV PI-based regimen, the HCV RNA test should have a lower limit of quantitation of at least 43 IU/m1 and a lower limit of detection of at least 10 Whirl. If the HCV RNA result is below the lower limit of detection, the report should indicate further if the HCV RNA is detectable or undetectable.
4. The RIBA supplemental test is no longer recommended for diagnosing chronic HCV infection.
HCV Genotype
An HCV genotype must be obtained prior to treatment initiation. The HCV genotype significantly influences the evaluation strategy, inmate counseling messages, the decision to treat, the specific medications and regimens, and the duration of therapy. Treatment response varies markedly by HCV genotype and medication regimen. Those with genotypes 2 or 3 have a 70-80% sustained viral response rate to pegylated interferon/ribavirin therapy, compared to a 4045% response rate for genotype 1. The addition of an HCV Protease Inhibitor to pegylated interferon and ribavirin increases the sustained viral response rate in genotype 1 to 60-80%. Repeat genotype testing is not indicated, except in the rare instance when re-infection is suspected.
Upon receipt of laboratory results, submit an HCV Specialty Referral to MPCH Referral Management.

Step 5. Assess liver fibrosis and need for a liver biopsy.
In inmates with chronic Hepatitis C, liver biopsy has been the primary means for determining the stage of the liver disease and the need for treatment. In general, inmates treated for HCV should have "more than portal fibrosis." General criteria for liver biopsy are outlined in Appendix 2, Step 5. Those with genotype 1 will ordinarily require a biopsy. Inmates with genotype 2 or 3 usually do not need a biopsy unless they are HIV-infected or another source of liver disease is suspected.
Calculation of APRI Recent data indicate that the degree of liver fibrosis is correlated with the AST/Platelet Ratio Index (APRI), a simple ratio of two common lab values. Higher APRI values have been associated with higher stages of liver fibrosis on biopsy. Therefore, MPCH should utilize APRI values when prioritizing referral of inmates with genotype I, 4, 5, orb for liver biopsies. Inmates who have an APRI of <0.5 are lower priority for biopsy; inmates who have an APRI of >0.5 are higher priority for biopsy - with the higher the APRI, the higher the priority for biopsy. The APRI calculation is provided below in Table 4.

Table 4. AST/Platelet Ratio Index (APRI) Calculation

Formula:

{AST / lab upper limit of normal (ULN)* for AST x 100) / (platelet count / 1000)

Example:

AST = 80, AST laboratory ULN = 40, Platelet count = 100,000 (80 / 40 x 100) / (100,000 / 1000) = 2.0 APRI

* Use "upper limit of normal (U1,1͚)" value that is used by the laboratory that ran the AST test.

Interpretation of Liver Biopsy Results
Histologically, fibrosis progresses along a continuum, with portal fibrosis representing an earlier stage of fibrosis and cirrhosis representing a late (or advanced) stage of fibrosis. The intermediate stages of fibrosis - periportal fibrosis and bridging fibrosis - as determined histologically are generally recognized as the most appropriate stage for initiating treatment. These intermediate stages of fibrosis correlate with the IASL, Ludwig and Metavir Stages "2" and "3," and the Ishak stages "3" and "4." Regardless of genotype, treatment should be considered with liver biopsy results as follows: IASL, Batts & Ludwig, or Metavir > Stage 2; or Ishak > Stage 3.

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The primary scoring systems for staging hepatic fibrosis on liver biopsy are compared in Table 5.

Table 5. Scoring Systems for Hepatic Fibrosis (IASL Ishak, Metavir, and Batts & Ludwig)

Score

IASL

Batts & Ludwig

Metavir

Ishak

0 No fibrosis

No fibrosis

No fibrosis

No fibrosis

I Mild fibrosis

Fibrous portal expansion

Periportal fibrotic Fibrosis expansion of some

expansion

portal areas, with or without

short fibrous septa

2 Moderate fibrosis
3 Severe fibrosis

Rare bridges or septae
Numerous bridges or septae

Periportal septae (>1 sPeoprttaulm-c)entral septae .

Fibrous expansion of most portal areas, with or without short fibrous septa
Fibrous expansion of most portal areas, with occasional portal-portal bridging

4 Cirrhosis

Cirrhosis

Cirrhosis

Fibrous expansion of most portal areas, with marked bridging (portal-portal and portal-central)

5

Marked bridging (portal-portal,

and portal-central) with

occasional nodules (incomplete

cirrhosis) .:

6

Cirrhosis, probable or definite

Note: The shaded area with the bolded text indicate a significant liver biopsy result with a degree of fibrosis for which antiviral therapy should be considered
Reference: Ghany, et al. AASLD practice guidelines. Diagnosis, management and treatment of Hepatitis C; an update. Hepatology, 2009; 49:1356-1358.

Step 6. Determine if treatment should be initiated.
Current HCV treatment options have some limitations in terms of both efficacy and toxicity. Each inmate with chronic Hepatitis C should be evaluated carefully to assess the relative risks and benefits of the following: beginning therapy immediately, delaying therapy, or deferring treatment indefinitely. Prior to initiating treatment, inmates should be counseled about the potential benefits of treatment Ͷ the likelihood of achieving a sustained viral response (SVR) Ͷ as well as the potential side effects. The rationale for treatment decisions should be documented in the medical record.
Indications for Antiviral Therapy Antiviral therapy is generally indicated for inmates with chronic Hepatitis C if they have no contraindications to treatment and present with at least one of the following:
- Genotype 1 and liver biopsy result with evidence of progressive fibrosis (either IASL, Batts & Ludwig, or Metavir > Stage 2; or Ishak > Stage 3)
- Genotype 2 or 3 (with no biopsy performed)

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Genotypes 4, 5, or 6, or untypeable: The best approach to management of these cases is not clearly defined by the medical literature. Until further data become available, the indication (but not necessarily the regimen) for treatment of genotypes 4, 5, or 6, or untypeable HCV should be the same as for genotype I as noted above.
Various co-infections or co-morbidities, such as cirrhosis and renal disease, may affect treatment decisions and are discussed later in the document.
Special Considerations Related to Initiating Antiviral Therapy The following co-morbidities, while not absolute contraindications, should be carefully assessed when considering whether or not to initiate antiviral treatment.
Mental illness: Interferon can cause or exacerbate depression, and causes mood changes in virtually all inmates. Therefore, inmates who have a history of major depression should be screened by a psychologist or a psychiatrist, and receive counseling on the risk of relapse of their depression posed by interferon treatment. For these inmates, careful consideration should be given to prophylactic treatment of depression. Utilize an SSRI (or the antidepressant that was most successful in treating the inmate's prior episodes of depression) for a period of three-to-six months prior to initiating interferon therapy. Similarly, other major psychiatric illnesses such as bipolar disorder, schizophrenia, and schizoaffective disorder should be well-controlled with stable doses of medication for at least six months prior to initiating interferon. Inmates with severe axis H diagnoses should be assessed by a mental health professional for their ability to comply with the frequent clinical and laboratory monitoring that is required for the safe administration of pegylated interferon and ribavirin.
Alcohol: HCV-infected inmates with significant alcohol abuse histories should receive specific counseling messages. Heavy and prolonged alcohol use is an independent risk factor for the development of cirrhosis, and alcohol accelerates the progression of HCV-related fibrosis. Hepatitis C treatment without abstinence from alcohol is unlikely to be of benefit. The treatment response to peginterferon plus ribavirin is significantly reduced in individuals who drink more than 30 grams of alcohol per day, and perhaps with lower levels of consumption, as well. An inmate's unwillingness to abstain from alcohol intake while incarcerated is a potential indicator of alcoholism and should be evaluated. Effective treatment for alcoholism should be offered in prison to as many HCV-infected inmates as possible, whether or not they have been administered Hepatitis C treatment or have responded to such treatment.
Substance abuse: Inmates who are significant abusers of substances other than alcohol may have a number of medical issues that can affect or be affected by Hepatitis C treatment. Injection drug users are at risk for HIV, HBV, endocarditis, and possible re-infection with HCV. Amphetamine and cocaine abuse may result in cardiovascular complications. Ongoing substance use in the controlled environment of prison or jail is, at best, an indicator that the inmate is not taking adequate responsibility for his or her overall health. Treatment decisions must be individualized where these issues are present,
Inmate Counseling In weighing treatment options, the following factors should be considered and discussed with the inmate:
- For those with chronic Hepatitis C infection, the risk of developing cirrhosis ranges from 5% to 25%, and usually occurs over a period of 25-30 years after initial infection.
It is difficult to predict which HCV-infected persons will develop cirrhosis or who will respond to treatment.
- The rate of sustained viral response (SVR) varies significantly by genotype and the medication used. Dual therapy (DT) with pegylated interferon and ribavirin achieves an SVR of 70-80% for genotypes 2 and 3, compared to only 40-45% for genotype 1. However, triple therapy for genotype 1 that uses one of the newly approved HCV Protease Inhibitors (P1) Ͷ either boceprevir or telaprevirͶin addition to pegylated interferon and ribavirin achieves SVR rates of 60-80%.
- Although current antiviral therapy is usually well-tolerated, there are many Ͷ and sometimes serious Ͷ side effects to antiviral therapy.
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- Close adherence to the drug regimen is essential to increasing the likelihood of "cure," as well as decreasing the risk
of virologic resistance in the case of triple therapy. - Future Hepatitis C treatments may be more effective and better tolerated than those currently available. At
this time, triple therapy is considered optimal for the treatment of HCV genotype I. However, this treatment can be complex and is associated with a higher rate of side effects than treatment with pegylated interferon and ribavirin alone; newer therapies that are projected to become available within a few years could simplify the regimen and decrease the risk of virologic resistance. For these reasons, the decision to treat HCV genotype 1 infection with stage 2 fibrosis should be made on a case-by-case basis after discussion with each inmate.
Inmates must be willing to be treated and willing to conform to the treatment requirements, including abstinence from alcohol, illicit drugs, and tattooing.
Treatment during pregnancy is generally contraindicated. Because treatment with ribavirin is known to be teratogenic, pregnancy must be avoided during treatment and for the six months after treatment is completed Ͷ in both female inmates and the female partners of male inmates.
Step 7. Conduct a pre-treatment evaluation.
Inmates should be evaluated by a provider and screened for other medical conditions that may complicate antiviral therapy. Lab work and tests should be obtained in accordance with the time frames enumerated in the HCV Referral Form.
Laboratory tests: See Appendix 3 for list of recommended baseline laboratory tests.
Baseline assessment of visual acuity, including fundoscopy for inmates with diabetes or other ophthalmologic disorders.
Pregnancy test for all female inmates: Ribavirin may cause fetal abnormalities. All female inmates of childbearing potential must have a pregnancy test immediately prior to initiating therapy and monthly thereafter up to at least 6 months post-treatment.
Cardiac risk assessment: A basic cardiac risk assessment, performed by a clinician prior to treatment initiation, is critical because the hemolysis associated with ribavirin may precipitate angina pectoris. An electrocardiogram should be obtained in inmates with preexisting cardiac disease. Symptomatic inmates should be carefully evaluated for cardiac disease prior to initiating treatment, as recommended by specialist.
Other inmate-specific diagnostic tests as medically indicated.
Mental health evaluation: Before prescribing medication therapy, a psychiatrist or psychologist should perform a mental health evaluation: to determine if mental health treatment is warranted prior to antiviral therapy and whether ongoing mental health assessments are needed during treatment.
- The evaluation should include an assessment of axis I and axis II diagnoses, including a comprehensive alcohol and substance abuse history and a suicide risk assessment. Interferon therapy has been associated with changes in mood and affect in most individuals. In a small percentage of inmates undergoing interferon therapy, significant depression, suicide attempts, and completed suicides have resulted. An inmate's history of depression or suicide attempts should prompt heightened vigilance on the part of the treating providers; however, since the absence of such a history does not appear to lessen the risk of these side effects from interferon, all inmates should be carefully monitored for changes in mood.
- Other mental illnesses or conditions, if not treated or not in remission, may adversely affect the inmate's ability to successfully complete a course of antiviral treatment, due to issues of compliance or to an inability to tolerate even mild side effects.
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Evaluation of inmates with compensated cirrhosis: Prior to treatment initiation, inmates with suspected or biopsyconfirmed, compensated cirrhosis should have a liver-spleen ultrasound or abdominal CT scan, and measurements of alpha-fetoprotein. If the ultrasound result points to the possibility of portal hypertension (marked splenomegaly, ascites, retrograde flow through the portal vein), then an upper endoscopy screening for esophageal varices should be performed. CT often reveals esophageal varices, which must then be endoscopically visualized to determine size and extent. If hepatocellular carcinoma (HCC) or decompensated cirrhosis is diagnosed, antiviral therapy is contraindicated. (See compensated cirrhosis and decompensated cirrhosis in Definitions section.)
Step 8. Determine appropriate treatment and obtain informed consent.
Treatment of chronic HCV is complex and may require expert consultation. If consultants from the local community are utilized, it is important to familiarize them with the MPCH's approach to this condition.
Triple Therapy Triple therapy with an HCV Protease Inhibitor (PI) such as boceprevir (VictrelisTM) or telaprevir (IncivekTm), in combination with pegylated interferon and ribavirin, is the preferred treatment for genotype 1 only. It is not indicated for the treatment of any other HCV genotype. HCV PIs are either contraindicated or not recommended in a number of other situations, as described below. In such cases, dual therapy for genotype 1 should be considered, unless it is contraindicated.
Indications for Triple Therapy HCV genotype only aml liver biopsy evidence of progressive fibrosis, Le., stage 2 (Batts and Ludwicr, periportal) or higher, including compensated cirrhosis.
Treatment-naive as well as relapsers or partial responders to prior therapy with pegylated interferon and ribavirin, may be considered.
Contraindications and Exclusions for HCV PIs for Genotype 1 Contraindications to pegylated interferon and ribavirin, including decompensated cirrhosis and pregnancy (HCV PIs should never be used as monotherapy).
- Co-infection with HBV or IJW
- Solid organ transplant - Medications that are inducers of or metabolized by CYP3A. Examples of medications that are either
contraindicated, not recommended, or require dosage adjustment or close monitoring when used in combination with HCV PIs include: Certain antiarrhythmics (amiodaronc, bepredil, digoxin, flecainide, lidocaine, propafenone, quinidine), macrolide antibiotics (clarithromycin, erythromycin, telithromycin), anticonvulsants (carbamazepine, phenobarbital, phenytoin), antidepressants (desipramine, trazadone), antifiingal (itraconazole, ketoconazole, posaconazole, voriconazole), calcium channel blockers (dihydropyridine and non-dihydropyridine), ergots (ergotamine, dihydroergotamine, ergonovine, methylergonovine), immunosuppressants (cyclosporine, simlimus, tacrolimus, and some inhaled or systemic steroids), PDE5 inhibitors (sildenafil, tadalafil, vardenafil), HIV protease inhibitors, sedative/hypnotics (alprazolam, midazolam, triazolam), statins (atorvastatin, lovastatin, simvastatin), alfuzosin, bosentan, colchieine, drospirenone, pimozide, rifabutin/rifampin, salmeterol, St. John's wort, warfarin.
NOTE: Inmates on medications that are either contraMdicated or not recommended should be assessed to determine the medical necessity of the medications they are taking, and should be considered for alternative medications in the same or a different class, as clinically appropriate. - Inability to adhere to a complex medication regimen, as demonstrated by past history of non-adherence to treatment plans or call outs, or unwillingness to consent to treatment
- Hypersensitivity to the specific HCV PI being considered, or any of its components.
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- Prior treatment failure with either a boceprevir- or telaprevir-based regimen.
Selecting the Most Appropriate WV PI for Genotype 1 Boceprevir (BCV) is the MPCH formulary agent. Telaprevir (TLV) may be considered where boceprevir is contraindicated and will be subject to non-formulary review.
Dosing of HCV Pis for Genotype 1 Boceprevir is 800 mg (four 200 mg capsules) by mouth every 8 hours (+1- 1 hour) with a snack. Telaprevir is 750 mg (two 375 mg tablets) by mouth every 8 hours (+1- 1 hour) with a 20-gram fat snack. Refer to Appendix 2, Step 8 and Appendix 6 for more information on dosing of HCV Pis.
Dosing of pegylated interferon and ribavirin is the same when used as dual therapy or as triple therapy in combination with an HCV PI. Detailed drug dosages and potential side effects of pegylated interferon and ribavirin are outlined in Appendix 2, Step 8, and Appendix 5. See Appendix 3, Hepatitis C Treatment Monitoring Schedule for information on monitoring parameters.
Notes on dosing of HCV PIs for genotype 1: I. HCV PIs should be prescribed and taken every 8 hours, not TID.
2. Boceprevir or telaprevir should always be prescribed at full doses or not at all. The doses should not be increased or decreased for any reason. They should be prescribed as noted above, or either discontinued or not prescribed at all, as determined by the clinical situation.
3. Each dose must be taken with food. For boceprevir, a light snack is sufficient. Telaprevir must be taken with a snack that has at least 20 grams offat.
4. These medications must be prescribed and taken eve)), 8 hours, +/- one hour. Adherence to this regimen is necessary to achieve safe and effective outcomes. However, the inmate should be counseled on management of missed doses. For either HCV PI, ifa dose is missed, the next dose should NOT be doubled. If a boceprevir dose is missed, the missed dose may be taken with food so long as it is remembered more than 2 hours before the next dose; it should be skipped if there are 2 hours or less before the next dose. If a telaprevir dose is missed, the missed dose may he taken with a 20-gram fat snack if it is remembered more than 4 hours before the next dose, but should be skipped if there are 4 hours or less before the next dose.
Dual Therapy Dual therapy with once-weekly pegylated interferon (pegylated interferon, alpha 2B is the formulary) injections and twice-daily oral ribavirin is the standard treatment for all HCV genotypes except genotype 1. Dual therapy may also be appropriate for treatment of genotype I when there are contraindications or exclusions to using HCV PIs, e.g., coinfection with HBV or HIV, or use of certain medications. (Refer to the section on Triple Therapy above, under Step 8 in Section 4.)
Standard dosing is detailed in Appendix 2, Step 8. See Appendix 5, Interferon/Ribavirin Drug Information for more detailed information on dosing in certain clinical circumstances, contraindications, and side effects. See Appendix 3, Hepatitis C Treatment Monitoring Schedule for information on monitoring parameters. Pretreatment Consent The medications used to treat HCV have significant potential side effects; these side effects for dual and triple therapy are outlined in Appendix 5 and Appendix 6, and should be discussed with the inmate prior to treatment initiation. Issues unique to the HCV Pis (compared to dual therapy) should also be discussed, including: the potential for development of resistance in the event of treatment failure, and the likelihood of new medications in the near future that might entail an all-oral regimen or have fewer side effects. In cases of mono-infection with HCV genotype 1 and a lower stage of fibrosis (e.g., stage 2, predominantly periportal fibrosis), the option of postponing treatment should be presented to the inmate and discussed. The MPCH Consent to Hepatitis C Treatment Form must be reviewed with and signed by the inmate and the primary care provider, prior to starting treatment.
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Step 9a. Manage side effects.
Recommended baseline, pre-treatment and ongoing clinical evaluations and laboratory studies are summarized in Appendix 3, Hepatitis C Treatment Monitoring Schedule. At a minimum, inmates receiving antiviral treatment should be clinically evaluated at weeks 1, 2, and 4, and then monthly thereafter. At each visit, inmates should be assessed for medication adherence, side effects and potential complications. Those with compensated cirrhosis (see compensated cirrhosis in Definitions section), HIV infection, or other co-morbid conditions will require more frequent monitoring, as will those who develop significant side effects or complications during therapy. While inmates are taking interferon, psychiatry and psychology consultations should be provided, as clinically indicated.
Throughout the inmate's treatment for Hepatitis C, the clinician's evaluations should be directed at inquiring about the common side effects of interferon and ribavirin in order to make decisions about dose adjustments; investigate new symptoms such as chest pain, dyspnea, or visual changes; or reassure the inmate that he or she is experiencing "normal" side effects of treatment.
Assessment and management of the more frequently occurring side effects from HCV treatment are discussed below:
- Flu-like symptoms: Muscle aches, headaches, and low-grade fevers are experienced by over 80% of inmates taking interferon. Inmates should be counseled to expect these symptoms, usually about 48 hours after the weekly injection, and resolving 24-48 hours before the next injection. These symptoms usually appear after the third or fourth dose of pegylated interferon, and tend to subside after about 3 months of treatment. Acetaminophen, up to 2 grams per day, and increased fluid intake may be recommended to manage these symptoms. Flu-like symptoms can be treated prophylactically by administering I gram of acetaminophen 30 minutes prior to peginterferon injection. Nonsteroidal anti-inflammatory agents (NSA1Ds) ordinarily should not be prescribed because of hepatotoxicity and the underlying liver disease.
- Mood changes: Virtually all inmates on interferon will experience at least some irritability. This should be discussed at each visit to determine if other symptoms of depression are developing. A low threshold for initiating an SSRI should be maintained while inmates are taking interferon.
- Rashes: A variety of deimatologic conditions are associated with both the HCV infection and the medications used to treat the HCV infection, including interferon/ribavirin and the HCV Pis. New rashes during treatment are usually mild and self-limited, or respond to topical low-potency corticosteroids.
There is an increased incidence of rash with those inmates on triple therapy that includes telaprevir. Incidence of rash occurs in approximately 50% of inmates using telaprevir in triple therapy, as opposed to approximately 30% in dual therapy. The rash usually develops in the first 4 weeks of triple therapy, but may occur any time during treatment. In general, the rash improves after the discontinuation of the medication, but may take weeks to fully clear. The rash may occur with or without pruritus and may range from mild to moderate to severe; however, severe or serious rashes are rare. Mild to moderate rash is defined as involving less than 50% of the body surface area. Severe rash is generalized, covers 50% or greater of the body surface, or includes the presence of vesicles, bullae, or ulcerations. Management of mild to moderate rash includes monitoring for progression/systemic symptoms and maintaining general skin care practices; oral antihistamines and/or topical steroids may be considered. Systemic corticosteroids are NOT recommended. Do not reduce the dose of HCV PI. Discontinue telaprevir if the rash progresses or becomes severe, or if systemic symptoms emerge. In this setting, pegylated interferon/ribavirin may be continued following discontinuation of telaprevir, but should be discontinued if the rash shows no improvement in 7 days. Consider oral antihistamines and/or topical steroids. Do not restart treatment.
- Chest pain: New onset of chest pain during HCV treatment should be presumed to be angina pectoris until proven otherwise. The development of anemia during treatment can precipitate angina in individuals with occult coronary artery stenosis.
- Visual disturbances: Ischemic retinopathy and retinal or vitreous hemorrhages can occur during interferon therapy, though rarely. The risk may be greater in diabetic inmates. These inmates should be counseled to
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immediately report any changes in vision. A baseline retinal examination prior to treatment is recommended for diabetics and those with preexisting ophthalmologic disorders, with fimdoscopie examinations performed periodically and as clinically indicated during treatment.
- Hair loss: Alopecia areata occurs in approximately 20% of inmates on HCV treatment. Inmates should be advised of this possibility, but also informed that this is self-limited after completion of treatment.
- Thyroid dysfunction: Approximately 4% of persons treated with interferon develop thyroid dysfunctions that may result in irreversible thyroid dysfunction Ͷ even with cessation of drug therapy, The occurrence of hypothyroidism usually can be managed with hormone replacement therapy while continuing interferon, on a case-by-case basis. Occurrence of hyperthyroidism usually necessitates discontinuation of interferon. If interferon must be discontinued due to thyroid dysfunction, the entire HCV treatment regimen must be discontinued as well.
- Anemia: A common complication of antiviral therapy is anemia. Ribavirin causes a dose-related hemolysis; whereas, interferon can suppress red blood cell production. The rates of anemia nearly double when one of the HCV PIs is added to pegylated interferon and ribavirin. Inmates who develop refractory anemia, progressive anemia beyond 8 weeks of treatment, or develop anemia late in the course of therapy should have a thorough evaluation for other treatable causes of anemia, such as iron deficiency anemia, gastrointestinal blood loss, and excessive menstrual blood loss. Specific strategies for managing drug-induced anemia are dependent on the degree of anemia, the presence of complicating co-morbidities such as heart disease, and the inmate-inmate's virologic response to antiviral therapy. Guidance regarding drug dosage adjustments, and criteria for the use of recombinant erythropoietin, are outlined in Appendix 2, Step 9b. If ribavirin must be discontinued due to anemia, the entire HCV treatment regimen must be discontinued as well.
Neutropenia: Interferon-induced bone marrow suppression may cause neutropenia. The majority of the inmates who develop neutropenia while on interferon have few serious side effects. Inmates with cirrhosis are at higher risk of neutropenic complications, such as sepsis, and should be followed closely. Specific strategies for neutropenia management are dependent on the degree of neutropenia, the extent of liver disease, the presence of co-morbidities that predispose to infection, and the inmate-inmate's virologic response to antiviral therapy. Guidance regarding interferon dosage adjustments and criteria for the use of granulocyte colony stimulating factor are outlined in Appendix 2, Step 9. If pegylated interferon is discontinued due to neutropenia, the entire HCV treatment regimen must be discontinued as well.
Thrombocytopenia: Thrombocytopenia from bone marrow suppression is a potentially serious complication of interferon therapy, particularly in inmates with cirrhosis who may have low platelet counts from the liver disease itself. Inmates with thrombocytopenia should be monitored closely while on antiviral therapy. Interferon should be dose-adjusted or discontinued, based on the degree of thrombocytopenia, as outlined in Appendix 2, Step 9b. If pegylated interferon is discontinued due to thrombocytopenia, the entire HCV treatment regimen must be discontinued as well.
- Dysgeusia: An altered sense of taste occurs more commonly in inmates treated for HCV infection, especially with the use of HCV PIs. There are no specific recommendations for the treatment of this side effect.
- Anorectal symptoms: Diarrhea, anorectal discomfort, hemorrhoids, itching, and burning occur more commonly with telaprevir. General measures for itching such as topical steroids or anesthetics and/or antihistamines at bedtime, and standard anti-diarrheal measures such as fiber or loperamide, may be helpful in controlling these side effects.
Step 9b. Monitor treatment response.
Assessment of the inmate's response to therapy is based on HCV RNA test results at certain intervals in the treatment process, as shown in Table 6. For all inmates, on-treatment HCV RNA levels should be obtained at the end of treatment weeks 4, 12, and 24, and again when the medication treatment is complete. For boceprevir-based regimens, an HCV RNA level also should be obtained at the end of treatment week 8.
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Table 6. HCV Treatment Response Categories

Testing Interval

If HCV RNA test shows ...

End of week 4*

Undetectable HCV RNA

End of weeks 4 and 12 Undetectable HCV RNA

End of week 12*

> 2 logio reduction in HCV RNA

The test result is considered ...
RVR Ͷ Rapid viral response
eRVR Ͷ Extended rapid viral response
EVRͶ Early viral response (EVR is also used to describe undetectable HCV RNA at TW 8 with BCV-based regimen)

End of week 12 End of week 24
End of recommended treatment period 24 weeks after ETR**
24 weeks after ETR

< 2 logio reduction in HCV RNA

Null responder

> 2 logio reduction in HCV RNA, but still Partial responder detectable

Undetectable HCV RNA

ETR Ͷ end of treatment (at treatment completion)

Undetectable HCV RNA

SVR Ͷ Sustained viral response (potential cure)

HCV RNA detectable

Relapser

* A viral response at week 4 and week 12 is closely correlated with treatment success. " For more information on assessing inmates for SVR, see Step 10 below.
The duration of triple therapy is determined by four variables:
1. The history of and response to prior HCV treatment with pegylated interferon and ribavirin, 2. The degree of liver fibrosis, specifically the presence or absence of cirrhosis, 3. Which of the two HCV Pis is used, and 4. The on-treatment response to triple therapy.
Step 8 of Appendix 2, summarizes the total weeks of therapy based on these variables.
NOTES: I. Pegylated interferon and ribavirin are prescribed for the entire duration of therapy. The HCV Pis are prescribed for a
shorter duration of time during the pegylated interferon and ribavirin treatment period. 2. The term treatment week (TW) refers to the number of weeks on treatment, starting with the first day of treatment
with any of the medications. 3. HCV RNA tests should be obtained at the end of TWs 4, 12, 24, and at the end of treatment, for a telaprevir-based
regimen. An additional HCV RNA test should be obtained at the end of DV 8 for a boceprevir-based regimen.
The medication regimens for triple therapy are relatively complicated. Refer to the table in Step 8 of Appendix 2, and the flowcharts in Appendix 4.
Boceprevir-Based Regimens All boccprevir-based treatment regimens start with 4 weeks of dual therapy of pegylated interferon and ribavirin, and no boceprevir. This comprises TWs I through 4. At the beginning of TW 5, triple therapy starts with boceprevir being added to the pegylated interferon and ribavirin. However, if at TW 4 an RVR (HCV RNA) is undetectable the BCV is not added. The inmate continues 44 weeks more of dual therapy.
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Four different treatment durations are possible Ͷ 28 weeks, 36 weeks, and two different 48-week regimens Ͷ as described below:
28 weeks: 4 weeks of pegylated interferon and ribavirin followed by 24 weeks of boceprevir, pegylated interferon, and ribavirin - 36 weeks: 4 weeks of pegylated interferon and ribavirin followed, by 32 weeks of boceprevir, pegylated interferon, and ribavirin
48 weeks (4+32+12): 4 weeks of pegylated interferon and ribavirin followed by 32 weeks of boceprevir, pegylated interferon, and ribavirin, followed by 12 more weeks of pegylated interferon and ribavirin. This regimen is the same as the 36-week regimen with an additional 12 weeks of pegylated interferon and ribavirin added at the end. Another way to understand this regimen is that pegylated interferon and ribavirin are prescribed for a fill 48 weeks from start to finishͶwith boceprevir added for 32 weeks in the middle, starting after TW 4 and continuing through TW 36. - 48 weeks (4+44): 4 weeks of pegylated interferon and ribavirin, followed by 44 weeks of boceprevir, pegylated interferon, and ribavirin. This is only indicated for inmates with compensated cirrhosis.
Which of these four regimens of boceprevir-based therapy to use for a given inmate is determined by the inmate's prior treatment history (with pegylated interferon and ribavirin) and outcome, degree of fibrosis on liver biopsy (no cirrhosis vs. compensated cirrhosis), and on-treatment response to therapy, as described below:
Treatment-naïve with no cirrhosis: - 28-week regimen if HCV RNA is undetectable at the end of TWs 8 and 24
48-week (4+32+12) regimen if HCV RNA is detectable at 8 weeks, < 100 1U/m1 at 12 weeks and undetectable at 24 weeks
Prior relapser or partial responder with no cirrhosis: - 36-week regimen if HCV RNA is undetectable at the end of TWs 8 and 24 - 48-week (4+32+12) regimen if HCV RNA is detectable at 8 weeks, < 10011J/m1 at 12 weeks and
undetectable at 24 weeks.
Compensated cirrhosis: - 48-week (4+44) regimen.
Indications for early discontinuation of boceprevir-based regimens due to treatment failure, as indicated by the HCV RNA response to treatment, include the following:
- HCV. RNA 7100 1U/rill at TW 12 or - HCV ItNA detectable at TW 24 or - HCV RNA increase of >1 logio from nadir while on treatment
If any of these criteria are met, all therapy should be discontinued, including boceprevir, pegylated interferon, and ribavirin. Other criteria for early discontinuation of therapy include the severe adverse reactions described under Step 9a, Management of Side Effects.
Telanrevir-Based ReRimens The first 12-week period of all telaprevir-based regimens includes all three medications Ͷ pegylated interferon, ribavirin, and telaprevir.
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After 12 weeks, telaprevir is discontinued, while pegylated interferon and ribavirin are continued for an additional 12 weeks (24 weeks total) or an additional 36 weeks (48 weeks total), as noted below.
Indications for 24 total weeks of therapy:
- Treatment-naïve or prior relapser with an undetectable on-treatment HCV RNA at both 4 and 12 weeks
Indications for 48 total weeks of therapy:
- Treatment-naïve or prior relapse with on-treatment HCV RNA detectable, but = 1,000 IU/int at 4 and 12 weeks, and undetectable at 24 weeks
- Partial responder to dual therapy with on-treatment HCV RNA = 1,000 IU/m1 at 4 and 12 weeks, and undetectable at 24 weeks
- Compensated cirrhosis with on-treatment HCV RNA -= 1,000 IU/m1 at 4 and 12 weeks, and undetectable at 24 weeks (see compensated cirrhosis in Definitions section)
Indications for early discontinuation of telaprevir-based regimens due to treatment failure include the following:
- FICV RNA>I000 1U/m1 at TW 4 or 12 or - HCV RNA detectable at TW 24 or - HCV RNA increase of > l login from nadir while on treatment
If any of these criteria are met, all therapy should be discontinued, including telaprevir, pegylated interferon, and ribavirin. Other criteria for early discontinuation of therapy include the severe adverse reactions described under Step 9a, Management of Side Effects.
The recommended duration of dual therapy varies by HCV genotype and on-treatment HCV RNA response (refer to Appendix 4 to see the following recommendations as flowcharts):
- Genotypes 1, 4, 5, and 6 are treated for 48 weeks. Genotypes 2 and 3 are treated for 24 weeks.
The optimal duration of dual therapy treatment for genotypes 4, 5, or 6, or untypeable HCV is unknown; these inmates should be treated with the 48-week course recommended for genotype 1.
Inmates who have HIV co-infection should be treated with 48 weeks of dual therapy, regardless of genotype.
Early discontinuation of dual therapy may be indicated, based on the documented response to treatment and the occurrence of side effects (see Appendix 2, Step 9, and Appendix 8).
Failure to achieve an EVR at 12 weeks is considered treatment failure (null response). Treatment should be discontinued.
If an EVR at 12 weeks is achieved, but HCV RNA is still detectable, the HCV RNA test should be repeated at 24 weeks of treatment. Detectable HCV RNA at 24 weeks is considered treatment failure. Discontinue treatment.
If the inmate fails to achieve an RVR at 4 weeks, but does have an EVR at 12 weeks, then 48 weeks of treatment is usually sufficient.
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For inmates who achieve an RVR at 4 weeks, but experience significant side effects:
- Genotypes 1, 4, 5, and 6: 24 weeks of treatment may be sufficient. Discontinuation of therapy after at least 24 weeks of treatment can be considered on a case-by-case basis in consultation with an expert.
- Genotypes 2 and 3: 16 weeks of treatment may be sufficient. Discontinuation of therapy after 16-20 weeks of therapy can be considered on a case-by-case basis in consultation with an expert.
Step 10. Assess for sustained viral response (SVR).
An HCV RNA test should be obtained 24 weeks after the treatment is completed. A sustained viral response (SVR) is defined as undetectable HCV RNA at 24 weeks after completion of the treatment. If an SVR is achieved, the infection is considered eradicated. Inmates who achieve an SVR should have an HCV RNA test obtained one year following the end of their treatment. Those who have undetectable HCV RNA at this time can be discontinued from the chronic care clinic (unless there are other medical problems or concerns regarding the possibility of re-infection).
Considerations Regarding Retreatment Inmates who do not achieve an SVR from antiviral therapy can be categorized as having a null response, partial response, or relapse, as defined in Appendix 2, Step 9b. Retreatment of such prior treatment failures should be considered on a case-by-case basis with the approval of the Statewide Medical Director, and with consideration of the following guidance:
- For treatment failures with non-pegylated interferon (with or without ribavirin), re-treatment should be considered on a case-by-case basis. HCV genotype 1 cases should be considered for triple therapy with an HCV PI-based regimen. Dual therapy with pegylated interferon and ribavirin of 48 weeks duration (in those who demonstrate an on-treatment virologic response) is used for retreatment of all other genotypes.
- Partial responders and relapsers to a regimen of pegylated interferon and ribavirin (dual therapy) can be considered for re-treatment if they have HCV genotype 1 and are appropriate candidates for treatment with an HCV PI-based regimen. All other genotypes will ordinarily not be re-treated. Although HCV PI-based regimens are approved for treatment of prior null responders to dual therapy, the response rates are relatively low. Considering the likelihood of developing viral resistance in the majority of such cases, retreatment with an HCV PI-based regimen is not currently recommended. Cases of advanced fibrosis or cirrhosis with prior null response to pegylated interferon and ribavirin should be considered for retreatment on a case-by-case basis.
- For treatment failures with an HCV PI-based regimen, re-treatment also is not indicated.
For inmates who are eligible for re-treatment, it should only be considered for those who are the most likely to benefit from therapy and who are at significant risk of disease progression. - Consensus interferon (interferon alfacon-1) is not recommended as an alternative re-treatment for prior treatment failures with a pegylated interferon and ribavirin regimen, due to the need for daily administration, as well as low response rates.
Long-term antiviral maintenance therapy for prior treatment failures has been found to be ineffective and should not be prescribed.
Section 5. Complicating Medical Conditions
Compensated and Decompensated Cirrhosis Inmates with HCV-related compensated cirrhosis can usually be treated with a standard regimen as described in this document. However, they have a higher rate of associated side effects, lower SVR rates, and should be monitored more closely.
Antiviral therapy is ordinarily contraindicated in inmates with Hepatitis C and evidence of decompensated cirrhosis, particularly if there is evidence of ascites or hepatic encephalopathy. Inmates with an isolated lab value indicating mild
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impairment in hepatic synthetic function, e.g., slightly depressed albumin or elevated 1NR, should be considered for treatment on a case-by-case basis.
Renal Insufficiency Persons with HCV infection have an increased risk of renal disease that may be associated with ciyoglobulinemia, and histologic findings that resemble idiopathic membranoproliferative glomerulonephritis (MPGN). Clinical manifestations include hetnaturia, proteinuria that is often in the nephrotic range, and a variable degree of renal insufficiency. Further diagnostic evaluation should be considered, e.g., eiyoglobulhis or renal biopsy, in consultation with a clinician experienced in the management of these conditions. Inmates with moderate-to-severe or progressive kidney disease (e.g., nephrotic syndrome, elevated plasma creatinine concentration, new hypertension, fibrosis, or tubulointerstitial disease on biopsy) should be considered for antiviral therapy for HCV infection, even in the absence of a degree of liver disease that ordinarily warrants antiviral therapy. Specific treatment regimens should be individualized in consultation with the Statewide Medical Director and available physician experts. Ribavirin should not be administered if the creatinine is >1.5 mg/dL or the estimated GFR is <50 rnL/min. Dose adjustments should be considered if the GFR is between 51-75 inUmin. Ribavirin should not be administered to inmates on dialysis. No dosage adjustments are required for the HCV PIs, boceprevir and telaprevir; however, they should not be prescribed when ribavirin is contraindicated.
Hemodialvsis The goal of treating Hepatitis C in persons with end-stage renal disease is to reduce the progression of liver disease and/or to clear the HCV infection in inmates who may later undergo renal transplantation. Evaluation of these inmates is complicated by several factors:
- ALT levels are more likely to be normal or near-normal in hemodialysis inmates, even in the presence of significant fibrosis
- The need for a liver biopsy must be balanced against the increased risk of severe bleeding - Hepatitis C treatment should be considered prior to referring the inmate for transplant (in consultation with
a nephrologist).
These cases will be discussed and evaluated on a case-by-case in consultation with subspecialists.
HBV and HCV Co-Infections
Coexistent infection with both HBV and HCV is estimated to be present in 10-15% of individuals with chronic Hepatitis, cirrhosis, or hepatocellular carcinoma. HCV superinfection in HBsAg carriers appears to reduce HBV DNA levels in serum and liver tissues and to increase the rate of HRsAg seroconversion. Most inmates who have dual HCV and HBV infections have detectable serum HCV RNA, but undetectable or low HBV DNA levels, which indicates that HCV is the predominant cause of liver disease in these inmates. However, in about one-third of inmates, levels of HBV DNA and HCV RNA fluctuate over time. Liver disease in co-infected individuals is usually more severe than in inmates infected by HBV alone. Inmates with dual HBV and HCV infection may also have a higher rate of HCC, compared to inmates infected by either virus alone, particularly those who are anti-HCV and HBeAg positive.
Antiviral therapy for inmates with HBV and HCV co-infections should be initiated with great caution, and only in consultation with a specialist, due to the uncertainty of the risks and benefits of treatment and the lack of a recommended treatment regimen. All cases that may be candidates for treatment should be reviewed with a physician with expertise in viral Hepatitis treatment, and be approved via the MPCH Central Office non-formulary review process. Currently, HCV Pis are not approved for use with HBV and HCV co-infection cases.
HIV and HCV Co-Infections The usual approach for screening for HCV infection should be applied to HIV-infected inmates. HIV-infected person with unexplained liver disease, a CD4 T-cell count <500 cells/mm3, and who are anti-HCV negative should have an HCV RNA assay obtained.
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Inmates co-infected with HIV and HCV have a two-fold increased risk of cirrhosis compared to those with HCV infection alone; thus they arc high priority among potential candidates for treatment. However, HCV treatment response rates are lower in HIV-infected inmates, and they have a higher risk of serious adverse effects.
Listed below are general recommendations related to the treatment of HCV/HIV co-infection. Prior to initiating treatment, consultation with an expert is recommended.
1. Co-infected inmates whose HIV infection is controlled and who have a significant liver biopsy result (either IASL, Batts & Ludwig, or Metavir > Stage 2; or Ishak > Stage 3), regardless of genotype, should be considered for HCV antiviral therapy.
2. Treatment for HIV and HCV infections should not be initiated simultaneously. If the inmate is a strong candidate for HIV treatment (AIDS or CD4+ T-cell count <350 cells/mm3), he or she should be treated first with HIV antiretroviral therapy. If not, consider initiating HCV antiviral therapy prior to initiating HIV treatment. It is generally recommended that several months elapse after initiating HIV antiretroviral therapy prior to initiating HCV treatmentͶso that adverse effects associated with the antiretroviral therapy can be distinguished from those associated with HCV treatment.
3. Inmates should be treated with peginterferon alfa and ribavirin at doses similar to those with HCV monoinfection.
4. Currently, HCV Pis are not approved for use with HIV and HCV co-infection cases, due to potential drug interactions and a lack of data to support the safety and efficacy when co-administered with HIV antiretroviral agents.
5. The recommended standard duration of HCV treatment is 48 weeks, regardless of genotype.
6. Drug interactions/contraindications/adverse reactions:
Co-infection with HIV and HCV increases the risk for antiretroviral-induced hepatotoxicity. This is especially true for stavudine, nevirapine, full-dose ritonavir, and tipranavir boosted with a low dose of ritonavir. If possible, these antiretrovirals should not be used to treat HIV inmates co-infected with HCV. Regardless of which antiretroviral therapy (ART) is used, ALT and AST should be monitored monthly with any new ART, and then every 3 months. Asymptomatic ALT elevations up to 5 times the upper limit of normal can be monitored safely and do not require discontinuation of ART. Further evaluation should be undertaken for greater increases in the ALT, which may require temporary discontinuation or changing of the ART.
Concurrent pharmacologic treatment of both HCV and HIV increases the risk for drug-drug interactions and drug toxicities. In particular, ribavirin increases the risk for pancreatitis and lactic acidosis in inmates treated with didanosine. Ribavirin also increases the risk of anemia in inmates treated with zidovudine. If possible, didanosine and zidovudine should be avoided or switched to another appropriate antiretroviral medication in 111V-infected inmates who are being considered for treatment of HCV infection with pegylated interferon and ribavirin.
7. Monitor closely those co-infected inmates for whom treatment is deferred (see Appendix 2, Step 3b). Calculate an APRI (see Table 4) every 6 months. Re-biopsy should occur at interval recommended by co-infection specialist.
Latent TB and Chronic HCV Co-Infection Inmates with latent TB infection (LTBI) and chronic HCV infection should be considered for isoniazid treatment. They should be monitored for hepatotoxicity in accordance with the same guidelines established for latent TB inmates who do not have HCV infection. All inmates require screening for symptoms of Hepatitis while taking isoniazid. Those inmates with baseline ALT elevations also warrant periodic monitoring of their ALT levels.
Co-infected inmates can be treated concurrently for Hepatitis C and LTBI; however, it is advisable to initiate LTBI treatment first, assess if it is tolerated, and then start Hepatitis C treatment six months later. If both treatments are started at the same time, and elevations of ALT occur, it is not possible to determine which is the offending agent. isoniazid should be discontinued in inmates with marked elevations in ALT or significant signs or symptoms of Hepatitis, in accordance with MPCH Guidelines for the Management of Tuberculosis.
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Section 6. Management of Cirrhosis
Transplantation Issues Liver transplantation is the treatment of choice for inmates with hepatic failure from chronic HBV and HCV infections. However, the lack of available donor organs limits this option, not only for inmate populations, but also for the general population.
Nevertheless, inmates with hepatic failure from viral Hepatitis may be assessed for eligibility for liver transplantation on a case-by-case basis by evaluating inmate-inmate-specific factors such as the following: MELD scores that help predict inmate-inmate mortality, medical contraindications for transplantation, mental health stability, evidence of ongoing substance abuse, criminal history factors that may negate successful transplantation, and imitate-inmate motivation (as evidenced by adherence to current treatment recommendations). Inmates who are potential candidates for liver transplantation should be advised of the limited access to donor livers and, where available, be referred to local transplant centers for evaluation.
Morbidity Assessment Based on MELD Scores The Model for End-Stage Liver Disease (MELD) predicts liver disease severity and the risk of three-month mortality using a "score" that is based on serum creatinine, serum total bilirubin, and prothrombin time (INR). In a study of inmates with end-stage liver disease, who were awaiting liver transplantation, three-month mortality was closely correlated with MELD scores:
MELD < 9 mortality = 2% MELD = 20-29 mortality = 20% MELD = 30-39 mortality = 53% MELD > 40 mortality = 71%
The value of MELD as a predictor of mortality is limited by its dependency on serum creatinine, which can fluctuate with changes in fluid status. MELD is a better predictor of mortality for particular populations than for any given individual. Nevertheless, MELD provides useful information for assessing the morbidity of inmates with end-stage liver disease.
All inmates with decompensated cirrhosis should have a MELD score determined to assess their mortality risk. MELD scores should be recalculated over several weeks for inmates with shifting fluid status. The MELD score can be calculated by utilizing a calculator provided by the United Network for Organ Sharing, available at http://optn.transplant.hrsa.gov/resources/MeldPeldCalculator.asp?index=98. Data required includes: date of birth, bilirubin, creatinine, 1NR, and dialysis status. Inmates with MELD scores of 30 or greater should be considered for Medical Referral Center designation.
NOTE: The MELD score predicts mortality, independent of clinical parameters such as hepatic encephalopathy, ascites, and variceal bleeding.
Preventive Measures The following preventive measures should be considered for inmates with cirrhosis:
- Immunize against influenza (annually), pneumococcal pneumonia, and Hepatitis A and B (unless immune). - Provide inmate-inmate education:
Eat a low-salt, low-fat, "heart healthy" diet. Completely abstain from alcohol during incarceration and after release. Avoid iron supplements and potentially hepatotoxic medications, such as nonsteroidal inflammatory drugs (NSAIDS).
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- Perform a baseline upper endoscopy (EGD) to screen for esophageal varices. Once esophageal varices have developed, the annual rate of hemorrhage is 5-15%. The frequency of follow-up EGD is determined by the presence of risk factors for progression or bleeding of the varices, including decompensated cirrhosis, red wale marks on the variceal surface, and size of varices > 5 mm. Annual EGD is recommended for inmates with decompensated cirrhosis, whether or not varices are present, and for those with a history of variceal hemorrhage. Biennial EGD is recommended for inmates who have small varices that have not bled and who are not being treated with nonselective beta-blockers. EGD is recommended every 3 years for compensated cirrhosis with no varices. In general, routine follow-up EGD is not required for varices that have not bled if nonselective beta-blocker therapy is prescribed.
- Nonselective beta-blocker therapy, such as propranolol or nadolol, is indicated for prevention of variceal hemorrhage in inmates with varices of any size that have not bled, with either decompensated cirrhosis or red wale marks on the varices, and for all inmates with a history of variceal hemorrhage. Nonselective betablockers may be appropriate for inmates who have varices that have not bled, but who have no other risk factors for hemorrhage. This treatment is not indicated for inmates with cirrhosis who have no esophageal varices. The dose of beta-blocker should be titrated weekly to reduce the resting heart rate by 25% Ͷ without reducing the pulse to less than 55 beats/minute or the systolic blood pressure to lower than 90 mm Hg. The usual starting dose for oral propranolol is 20 mg twice each day, and for nadolol, 40 mg once daily. Once started, therapy should be continued indefinitely unless contraindicated. Nonselective beta-blocker therapy is relatively contraindicated in certain medical conditions such as asthma, peripheral vascular disease, and insulin-requiring diabetics with frequent hypoglycemic episodes.
- Provide primary and secondary prophylaxis for spontaneous bacterial peritonitis (SBP) with an antibiotic such as ciprofloxacin, or trimethoprim-sulfamethoxazole (TMP-SMX). Primary prophylaxis generally involves limited treatment periods in high risk inmates, such as those with upper gastrointestinal hemorrhage. Secondary prophylaxis is indicated in inmates with a history of one or more prior episodes of SBP. Oral medication options include: ciprofloxacin, 750 mg weekly; or TMP-SMX DS, one tablet daily.
- Provide prophylaxis against hepatic encephalopathy, and be alert for the common factors which cause exacerbations of encephalopathy. Lactulose is the mainstay of both treatment and prophylaxis for hepatic encephalopathy. Lactulose lowers the gut pH and converts NH3 (ammonia) to NH4, which is non-absorbable and thus excreted in the stool. Certain antibiotics such as neomycin and rifaximin are also sometimes prescribed to alter the gut flora and thereby decrease ammonia production. However, good, controlled studies are lacking that clearly support the use of antibiotics over lactulose; moreover, long-term use of antibiotics has the potential for bacterial overgrowth syndromes. Neomycin also has potential nephrotoxicity and ototoxicity.
The dose of lactulose (10 grams/15mL) is inmate-inmate-specific, typically starting at 15-30 nft. once or twice daily until the inmate-inmate is having two or three soft stools per day. If this dose does not adequately address the cognitive impairments, the dose may need to be increased, causing more frequent, semi-liquid stools.
Lactulose enemas are the treatment of choice for somnolent inmates with encephalopathy who are unresponsive to verbal and/or painful stimuli. One liter of 20% lactulose is infused per rectum every hour until the inmate-inmate becomes arousable. Inmates with abnormal vital signs, low pulse oximetty, or periods of apnea should be hospitalized or placed on an ininmate-inmate unit at an IVIRC for this treatment.
Common factors which exacerbate hepatic encephalopathy are:
- Excess dietary protein intake - GI bleeding
Infections (increased temperature results in dehydration) - Sedative/hypnotic and opiate use (even at "typical" doses)
Overzealous diuresis with loop diuretics. (Decreased potassium and decreased plasma volume result in increased ammonia levels. Titrate diuretics incrementally, and correct hypokalemia when detected.)
Screen for hepatoceilular carcinoma (HCC). Inmates with chronic HCV infection and cirrhosis are at increased risk for HCC. Although the optimal screening strategy is uncertain, a liver ultrasound should be considered every six months as the safest and most cost-effective approach. Screening should be conducted regardless of whether
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or not the inmate has been treated for Hepatitis C. Serum alpha-ktoprotein screening is of limited use, since it is not usually elevated to a significant level until the tumor is at least 2 cm Ͷ which is easily detectable on ultrasound in virtually all inmates. CT scanning should ordinarily not be used in lieu of ultrasound for HCC screening, due to the high radiation exposure that would be anticipated over ten or more years of biannual scans.
HCC screening should begin when the inmate is found to have cirrhosisͶwhether by history, by liver biopsy, by presentation of decompensation such as bleeding esophageal varices or hepatic encephalopathy, or based on a pattern of clinical or laboratory findings. Ultrasound screening should be conducted on any HCV-infected inmate with the typical laboratory findings of cirrhosis, which include an inverted AST/ALT ratio, an albumin < 3.4, and a platelet count < 120-140K. An AST to platelet ratio index (APRI) significantly greater than 1.5 is also strongly suggestive of cirrhosis, and may be used as an independent marker to start screening for HCC (see Table 4 for calculation).
Managing Complications and Co-Morbidities Ascites: Of the major manifestations of decompensated cirrhosis, the most common is ascites. A diagnostic paracentesis by qualified personnel should be performed in newly presenting cases of ascites, and should include assessment of ascitic fluid cell count with differential, ascitic fluid total protein, and serum-ascites albumin gradient. A serum-ascites albumin gradient = 1.1 g/d1., is indicative of portal hypertension as the cause. Ascitic fluid cultures should be collected in blood culture bottles if infection is suspected, e.g., fever, abdominal pain, etc. Eighty-five percent of cases of ascites are caused by cirrhosis.
The primary treatment includes dietary sodium restriction of 2 gm/day, and a combination of oral diuretics using spironolactone and furosemide (starting at 100 mg and 40 mg, respectively) once daily in the morning. Monotherapy with spironolactone achieves less dramatic diuresis and is associated with a higher rate of hyperkalemia, but may be effective in the presence of smaller amounts of ascites or edema. If the desired weight and fluid loss is not achieved, these doses may be increased every 3 to 5 days (maintaining the same ratio) up to a maximum of 400 mg/day of spironolactone and 160 mg/day of furosemide. With this regimen, 90% of inmates with ascites can achieve the goals of treatment, which include a 24-hour urinary excretion of sodium > 78 mmol/day, and diuresis of ascites and edema with a maximum rate of weight loss of 0.5 Kg/day. A greater rate of weight loss is appropriate for inmates with greater amounts of edema. A spot urinary sodium/potassium ratio > l correlates fairly well with a 24-hour urine sodium excretion > 78 mmollday and is easier to obtain.
Failure to achieve treatment goals should prompt an assessment of adherence to sodium restriction and diuretic therapy, the use of nonsteroidal anti-inflammatories, which interfere with diuresis, and consideration of other causes of ascites. Amiloride may be used in place of spironolactone for inmates with painful gynecomastia. Although eplerenone, a selective tnineralocorticoid antagonist, has a much lower incidence of gynecomastia, its role in the treatment of ascites has not been well studied. Fluid restriction is indicated for serum sodium < 120-125 mFq/L. Diuretics should be discontinued if serum creatinine rises to > 2 ing/dL, serum sodium drops to < 120 mEq/L despite fluid restriction, or encephalopathy develops. Abstaining from alcohol and treatment for chronic Hepatitis B virus infection may improve the symptoms of decompensated cirrhosis from these causes. Treatment of ascites that is refractory to these interventions may include serial paracenteses, transjugular intrahepatic portasystemic shunt (TIPS), which usually is performed by an interventional radiologist, and/or liver transplantation. TIPS is effective in reducing ascites and rates of rebleeding from esophageal varices, but may be associated with more frequent or severe episodes of encephalopathy and does not improve mortality rates. Contraindications to TIPS include: primary prevention of variceal bleeding, congestive heart failure, moderate to severe pulmonary hypertension, uncontrolled infection or sepsis, bifiary obstruction, multiple hepatic cysts, hepatocellular carcinoma, hepatic vein obstruction or portal vein thrombosis, severe coagulopathy with 1NR > 5, or platelet count < 20,000/cm3.
Pruritus: Pruritus in cirrhosis is thought to be due to increased bile acids from cholestasis, as well as possibly an increased production of endogenous opioids. Cholestatic pruritis may be caused by enhanced concentrations of bile salts in the systemic circulation and peripheral tissues, which is seen in inmates with primary biliary cirrhosis and chronic renal failure. Intestinal anion exchange resins such as cholestyramine, colestipol, and colesevelam bind many hydrophobic bile acids in the intestine and inhibit enterohepatic reuptake of intestinal bile salts; they are effective in decreasing disease-related, enhanced concentrations that can cause cholestatie pruritis. Sertraline, at 75-100 mg daily, has been found to be effective in inmates suffering from various forms of cholestasis. Naltrexone, an opioid antagonist, at 12.5-50 mg per day, may also
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be effective. Exogenously administered narcotics can contribute to pruritus, so the inmate-inmate's need for these medications should be carefully evaluated in the context of the management of pruritus.
Depression: Inmates with cirrhosis often have comorbid depression, especially when they have decompensated cirrhosis and are struggling with ascites, wasting, and encephalopathy. Although any of the SSRIs may be effective, most require approximately 50% dose reduction to accommodate delayed hepatic metabolism. Avoid SSRIs with a long half-life, e.g., fluoxetine. Sedating antidepressants such as mirtazapine, doxepin, trazodone, and amitriptyline should be either avoided or prescribed in very low doses, due to their potential for adding to the cognitive impairments of hepatic encephalopathy.
7. Infection Control
Infection control issues including inmate-inmate education, reporting, containment, contact investigation and post-exposure management are detailed in the MPCH Infection Control Manual, available at all inmate-inmate locations.
8. Definitions & Abbreviations
APRI (AST Platelet Ratio Index) is a score based upon commonly available lab values that is sometimes used to assess the degree of liver fibrosis (see Table 4 for calculation).
Absolute contraindication is a condition or factor that by itself precludes a specific intervention.
Anti-HCV is the antibody to HCV core and nonstructural proteins, detectable from several weeks to months after clinical Hepatitis.
Anti-HCV screening assay is an immunoassay such as an enzyme immunoassay (EIA) or a chemiluminescence immunoassay (CIA); it is used to screen for HCV infection by measuring antibodies to HCV antigens.
Compensated cirrhosis is defined as: bilirubin <1.5 mg/dL; international nonnalized ratio (INR) <1.5; albumin >3.4 g/dL; and platelet count >75,000/mm3; as well as no evidence of: ascites by liver ultrasound, esophageal varices by upper endoscopy, or hepatic encephalopathy.
Decompensated cirrhosis is defined as: evidence of significant liver disease (such as ascites, encephalopathy, marked thrombocytopenia, and bleeding esophageal varices), as well as loss of liver synthetic function (e.g., albumin <3.4 g/dL, and international normalized ratio (INR) >1.5).
Early viral response (EVR) during treatment of chronic Hepatitis C is a minimum two log (2 log10) decrease in the level of HCV RNA (compared to pretreatment levels) after the first 12 weeks of treatment, as measured by an HCV RNA assay. This term has also been used to describe an undetectable HCV RNA level after 8 weeks of treatment with a boceprevir-based regimen.
End of treatment response (ETR) after antiviral treatment of chronic Hepatitis C is the absence of detectable HCV RNA immediately after the completion of a course of treatment (usually 24 weeks for genotypes 2 and 3, and 48 weeks for genotype 1). Extended Rapid Viral Response (eRVR) to treatment for chronic Hepatitis C is defined as undetectable HCV RNA after both 4 and 12 weeks of treatment.
Hepatic steatosis, also known as "fatty liver," is the collection of excessive amounts of triglycerides and other fats inside liver cells.
Hepatitis C is an acute or chronic viral Hepatitis caused by an RNA virus that is transmitted primarily by percutaneous contact with blood.
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HCV is Hepatitis C virus, an enveloped, single-stranded RNA virus.
Model for End-stage Liver Disease (MELD) is a validated, disease severity index that uses age, creatinine, bilirubin, and prothrombin time to predict mortality. Null Response to treatment for chronic Hepatitis C is defined as less than a 2 log10 decrease in HCV RNA after 12 weeks of treatment. Partial Response to treatment for chronic Hepatitis C is defined as greater than or equal to a 2 log10 decrease in HCV RNA, but where HCV RNA is still detectable after 24 weeks of treatment.
Rapid viral response (RVR) during treatment of chronic Hepatitis C is defined as undetectable HCV RNA after the first 4 weeks of treatment. Relapse associated with the treatment for chronic Hepatitis C is defined as undetectable viremia at the end of treatment, but then subsequent detection of HCV RNA virus after treatment is stopped.
Relative contraindication is a condition or factor that may preclude a specific intervention when considered in conjunction with other criteria.
RIBA (anti-HCV) is the recombinant immunoblot assay that measures antibodies to HCV antigens through immunoblot technology. RIBA is no longer routinely used to confirm HCV infection.
Standard precautions are protective measures to be used for all inmate/inmate contacts in situations where infections can be transmitted by contaminated blood and body fluids. Precautions include: (1) the wearing of gloves and other personal protective equipment that provide an impervious barrier when soiling is likely; (2) procedures for protective handling of contaminated materials and equipment (e.g., using puncture-resistant devices and leak-proof protection); and (3) routine cleaning of all contaminated surfaces and equipment.
Steatosis (see Hepatic steatosis above)
Sustained viral response (SVR) after antiviral treatment of chronic Hepatitis C is the absence of detectable HCV RNA in the serum 24 weeks after the treatment is completed; it is measured by an HCV RNA assay.
9. References United States. US Department of Justice. Federal Bureau of Prisons. Evaluation and Treatment of Hepatitis C and Cirrhosis. Federal Bureau of Prisons, Mar. 2012. Web. Aug. 2012. <http://xww.bop.govinews/medresources.jsp>.
Health care delivery within each.facility is a mutual concern of the Department of Correction and clinical providerͻ. Matters of clinical judgment are the sole province of the licensed health care professionals; however, all health care providers shall ensure that the delivery of health care is in accordance with the security requirements of the facility as determined by the superintendent. In doing so, variations in the implementation of these protocols may be required.
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Appendix I. Treatment of Acute Hepatitis C Infection

In the patient with recent onset of high risk, the Research Assistant (RA) should be contacted by calling:

or e-mailing

. The RA will see the patient and draw additional laboratories as needed. If she cannot

see the patient in a timely manner, the RA will contact the facility to give expert guidance regarding further laboratory

assessment. Other causes of acute Hepatitis can include acute Hepatitis A and B infection.

Patients with acute Hepatitis infection need careful follow-up to determine if they are well enough to drink and cat. Also LFTs and 1NR need to be drawn if the ALT is five times normal. The ID consultant should also be contacted if the INR is abnormal.
Patients with suspected acute Hepatitis C should be seen in Dr. McGovern's Hepatitis Clinic by the 121h week after identification. At this visit, all laboratories, including the 10th week HCV RNA level will be reviewed to determine if the patient may have had spontaneous resolution of infection or if the patient needs treatment for persistent infection. When treatment is offered early, the chance of cure is greater than 90%t. Furthermore, the length of therapy can often be shortened.

The RA will complete off-site consult form for this appointment and will draw, or order, the following laboratories:

Initial Visit Consent Research laboratory tests HCV RNA LFTs Initiate off-site consent for co-infection visit for week 12

Week 4 HCV RNA LFTs

Week 10 HCV RNA LFTs

Week 12 Co-Infection Clinic visit to review all laboratory results and discuss treatment plan. Any other needed laboratories will be drawn at LSH at this time.

Week 16 Start therapy, if necessary.

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Appendix 2. Stepwise Approach for Detecting, Evaluating, and Treating Chronic Hepatitis C

Outlined below are MPCH's steps for detecting, evaluating, and treating Hepatitis C. Refer to the text in Section 4 for further information about each step.

Inmate Name: Inmate No.: DOB: Institution/Unit:

Step I. Appropriately screen for Hepatitis C. q Assess for presence of Hepatitis C risk factors:
- Presence of certain clinical conditions (regardless of sentencing status):
q Chronic hemodialysis (screen ALT monthly and anti-HCV semi-annually) q Elevated ALT levels of unknown etiology q Evidence of extrahepatic manifestations of HCV (mixed cryoglobulinemia, mebranoproliferative
glomerulonephritis, or porphyria cutanea tarda)
Presence of. Hepatitis C risk factors (sentenced inmates only):
q Ever injected illegal drugs or shared equipment q Received tattoos or body piercings while in jail or prison q H1V-infected or chronic HBV infection q Received a blood transfusion or organ transplant before 1992, or received clotting factor transfusion
prior to 1987 q History of percutaneous exposure to blood q Ever received hemodialysis
q Screen for anti-HCV (EIA or CIA) if risk factors are present or if inmate requests a test. Step 2. Provide initial medical follow-up for anti-HCV positive inmates. q Take a medical history and perform a physical examination.
q Try to establish duration of HCV infection by history, e.g., time period of injection drug use.
q Obtain baseline labs (see Appendix 3).
q Evaluate inmate for other potential causes of liver disease.
q initiate inmate counseling (see inmate education resources, Appendix 7).
q Initiate preventive health measures listed below:
- Hepatitis B vaccine: Indicated for inmates with chronic HCV infection. For foreign-born inmates, consider prescreening for Hepatitis B immunity prior to vaccination. Inmates with evidence of liver disease should be priority candidates for Hepatitis B vaccination.
- Hepatitis A vaccine: Indicated for inmates with chronic HCV infection who have other evidence of liver disease. For foreign-born inmates, consider prescreening for Hepatitis A immunity prior to vaccination.
- Pneumococcal vaccine: Offer to all HCV-infected inmates with cirrhosis.
Influenza vaccine: Offer to all HCV-infected inmates annually. Inmates with cirrhosis are high priority for influenza vaccine.
- Hepatocellular carcinoma (HCC) screening: Data supporting specific parameters for HCC screening are lacking. For inmates with both cirrhosis and chronic HCV infection, some experts recommend screening by liver ultrasound every six months
- Esophageal varices screening: Consider an upper endoscopy for any inmate with known cirrhosis, and for those

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with suspected cirrhosis who are not candidates for liver biopsy.
Step 3a. Determine if Hepatitis C treatment is not recommended.
Hepatitis C treatment is not recommended if any of the following conditions are present:
1. Contraindications to peginterferon:
® Severe uncontrolled psychiatric disease, particularly depression with current suicidal risk. ® History of solid organ transplant (renal, heart, or lung) ® Certain autoimmune disorders, e.g., autoimmune Hepatitis ® Uncontrolled endocrine disorders, e.g., diabetes, thyroid disease ® Serious concurrent medical diseases, such as severe: hypertension, heart failure, coronary heart disease,
COPD ® Decompensated cirrhosis (see Complicating Medical Conditions) ® Platelet count <75,000/mm3 or ANC <1,500 cells/min3 ® Documented nonadherence to prior therapy, or failure to complete pretreatment evaluation process ® Ongoing injection drug use or alcohol use ® Hypersensitivity to interferon

2. Contraindications to ribavirin:
® Thalassemias (sickle cell anemia) or other hemoglobinopathy. ® Significant cardiac disease (arrhythmias, angina, CABG, MI) in the past 12 months. ® Pregnancy or unwillingness to use contraception in both female inmates and female partners of male
inmates.Uncontrolled endocrine disorders, e.g., diabetes, thyroid disease ® Renal dialysis or creatinine clearance < 50 mL/min ® Hypersensitivity to ribavirin

3. Inmate will be incarcerated for an insufficient period of time to complete treatment.
4. Inmate has an unstable medical or mental health condition which precludes antiviral therapy. (Evidence of non-compliance with medical, social, mental health treatment plan(s) within the past twelve months.)
5. Inmate refuses treatment. 6. Refusal to participate in substance abuse treatment. 7. Pregnancy,

STOP

If any one of the above conditions are present, then STOP further treatment-related work-up. No further HCV testing Ͷ i.e., HCV RNA, genotype, liver biopsy Ͷ is indicated at this time. If conditions change, reconsider for Hepatitis C treatment.

Step 3b. Monitor HCV-infected inmates who are not on treatment.
® Have a plan for each inmate: Outline the plan clearly on the Problem List. ® Get baseline laboratory evaluations: Obtain baseline labs as specified in Appendix 3. ® Follow-up labs:
- Every 6 months: ALT, AST, bilirubin, albumin, and INR - Every year: CBC (with differential & platelets). Calculate APRI (see Table 4 for formula). - Other labs as clinically indicated, e.g., Al C (diabetics); TSH and free T4 (if hyperthyroid).
® Repeat liver biopsies: The determination regarding the timing of re-biopsy (for those inmates whose treatment is deferred) should be based on subsequent increases in the AST/Platelet Ratio Index (APRI) and/or evidence of steatosis or inflammation. Those who develop clinical evidence of liver disease should be priority candidates for re-

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biopsy. If the APRI < 0.5, there is a lower risk of disease progression; if the APRI > 0.5, there is a higher risk.
Note: The following tests are generally NOT indicated for inmates not on treatment.
- HCV RNA and HCV genotype: These tests are not needed unless treatment is indicated. Do not periodically check HCV RNA values for inmates who are not currently candidates for treatment. There is no correlation between HCV RNA levels and the risk or rate of disease progression.
- Alpha fetoprotein: Unless cirrhosis is known or strongly suspected, alpha fetoprotein is unnedessary because the risk for hepatocellular carcinoma in HCV infection does not begin until the development of cirrhosis.
- Liver ultrasound or CT examination: Similarly, do not perform periodic liver ultrasound or CT examinations unless cirrhosis is present or there is another definitive indication.
- Serium ammonia levels: In an inmate with known liver disease, the serum ammonia level has no prognostic value; nor can it be used for monitoring the effectiveness of medications such as lactulose. Serum ammonia levels are only useful in a delirious inmate whose diagnosis is uncertain.
For inmates who may be eligible for Hepatitis C treatment, proceed as follows.
Step 4. Obtain HCV RNA assay and HCV genotype. ® Before initiating antiviral therapy, an HCV RNA (viral load) is required in order to continn chronic infection and guide therapy. If the HCV RNA level is undetectable, the individual can be considered uninfected. ® The HCV genotype should be ordered in conjunction with the initial HCV RNA test. In general, the test for genotype Is not repeated ʹ unless re-infection is suspected.
Step 5. Assess liver fibrosis and need for a liver biopsy. ® Determine if a liver biopsy is indicated based upon the criteria below:
® HIV infection: High priority for liver biopsy, regardless of genotype.
® Other liver disease suspected: High priority for liver biopsy, regardless of genotype, e.g., homozygous hemochromatosis
® Genotypes 1, 4, 5, 6: Biopsy is generally recommended. Prioritize referral of inmates for biopsy based on the AST/Platelet Ratio Index (APRI). If APRI < 0.5, lower risk of progression; if APRI > 0.5, higher risk.
® Genotypes 2, 3: Biopsy is not needed prior to treatment (except if HIV-infected or other type of liver disease is known or suspected).
® Compensated cirrhosis: Decide about liver biopsy on a case-by-case basis, in consultation with a Hepatitis C expert. Either perform a liver biopsy as soon as possible, or treat empirically without biopsy confirmation.
® Decompensated cirrhosis: Liver biopsy and treatment are generally not indicated (see section 5, Complicating Medical Conditions, in the text.)
Step 6. Determine if treatment should be initiated. ® Identify if any of the following indications for antiviral therapy are present:
® Genotype 2 or 3 with no biopsy performed. ® Liver biopsy reveals chronic Hepatitis with significant fibrosis: (IASL, Batts&Ludwig, or Metavir > 2, or
Ishak ? 3) Ͷ regardless of genotype (see Table 5). ® Compensated liver disease (bilirubin <1.5 mg/dL; INR <1.5; albumin >3.4 g/dL; and platelets
>75,000/nun3; as well as no evidence of: ascites, esophageal varices, or hepatic encephalopathy.
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q Review special considerations related to treatment initiation (i.e., mental illness, substance abuse, adherence concerns). See section on Special Considerations under Step 6 in text.
q Counsel inmate regarding the pros and cons of initiating Hepatitis C treatment. See section on Inmate Counseling under Step 6 in text.
q Determine if inmate is willing to be treated and to adhere to treatment requirements. q Document rationale for decisions about treatment in the medical record.
Step 7. Conduct a pre-treatment evaluation. Assure that all recommended pre-treatment evaluations have been completed within the time frames enumerated in the "Treatment Approval Form". q Laboratory tests: See Appendix 3 for list of recommended pre-treatment tests and evaluations.
q Interferon Ͷ The inmate should have the following acceptable labs for treatment initiation: absolute neutrophil count >1500/cells/mm3; platelets >75,000/mm3. When starting treatment with platelet counts between 75-90,000, consult first with a physician with expertise in treatment of Hepatitis C.
q Ribavirin Ͷ The inmate should have the following acceptable for treatment initiation: Hemoglobin >13 g/dL (men) or >12 g/dL (women); creatinine <1.5 mg/dL (or creatinine clearance >50 mL/min). Some experts recommend that an acceptable starting hemoglobin is >12 g/dL (men) or > I 1 g/d1_, (women).
q Pregnancy test: Because ribavirin may cause fetal abnormalities, all female inmates of childbearing potential must have a pregnancy test immediately prior to initiating therapy, and monthly thereafter. Continue with monthly tests until 6 months after treatment is completed.
q Cardiac risk assessment: Prior to therapy, a cardiac risk assessment is critically important because hemolysis associated with ribavirin may precipitate angina pectoris. Also, obtain an ECG for inmates with preexisting cardiac disease.
q Mental health evaluation is critically important prior to initiating treatment due to the severe psychotropic effects of interferon.
q Compensated cirrhosis: Obtain liver-spleen ultrasound (preferred) or abdominal CT-scan, and measurements of alpha fetoprotein, prior to treatment initiation. A screening upper endoscopy is indicated if the ultrasound suggests portal hypertension.
MPCH Clinical Practice Guideline: Evaluation and Treatment of Hepatitis C and Cirrhosis 12/13/2012 Page 29

Case 1:15-cv-12298-NMG Document 35-1 Filed 05/16/16 Page 30 of 43

Step 8. Determine appropriate treatment and obtain informed consent. ® Dual therapy (pegylated interferon plus ribavirin). Standard dosing is outlined in Appendix 5. Also, see Appendix 5
for information on dosing with renal failure and HIV/HCV co-infection.
® Triple therapy (pegylated interferon plus ribavirin plus HCV protease inhibitor).

Prior Treatment History or Degree of Fibrosis Treatment Naive, No Cirrhosis
Relapser with Dual Therapy, No Cirrhosis
Partial Responder with Dual Therapy, No Cirrhosis
Compensated Cirrhosis

28
RNA (-) at TW8 and TW24

Dosing and Treatment Duration in Triple Therapy

Boceprevir-Based Regimen

Total Weeks of Therapy

36

48/

482

RNA < 100 IU/m1 but (+) at TW8 and (-) at TW24

RNA (-) at TW8 and TW24

RNA < 100 1U/mi but (+) at TW8 and (-) at TW24

RNA (-) at TW8 and TW24

RNA < 100 1U/nil but (+) at TW8 and (-) at TW24

RNA < 100 Mind at TW8 and (-) at TW24

Telaprevir-Based Regimen

Total Weeks of Therapy

24

48

RNA (-) at TW4 and TW . 12 .
RNA (-) at TW4 and TW 12 ͻ

RNA < 1000 IU/tni but (+). at TW4 and/or TW12 and.(-) at TRWNA245 1000 IU/nil but (+) at TW4 and/or TW12 and (-) at TRWNA24< 1000 Mimi at TW4 and. TW12 and (-) at TW24
RNA < 1000 IU/mi. at TW4 . and TW12 .. and (-) at... TW24

® Obtain informed consent after reviewing potential side effects.
9a. Manage side effects.
® Monitor side effects of treatment. See Appendix 3 for treatment monitoring schedule for recommended baseline, pre-treatment, and on-going clinical evaluations and laboratory studies. See Guidelines for Adjusting Therapy for CBC Changes in Step 9 below.
® Common toxicities to assess at each clinician visit include: ® Flu-like symptoms ® Mood changes ® Rashes ® Chest pain ® Dyspnea / cough ® Thrombocytopenia ® Anemia ® Neutropenia

MPCH Clinical Practice Guideline: Evaluation and Treatment of Hepatitis C and Cirrhosis 12/13/2012 Page 30

Case 1:15-cv-12298-NMG Document 35-1 Filed 05/16/16 Page 31 of 43

Step 9b. Monitor treatment response. Monitor for treatment response based on the following virologic end-points:

Chronic Hepatitis C Treatment Response Categories

Response

Timeframe

Result*

RVR (Rapid Viral Response)

After 4 weeks of treatment

HCV RNA undetectable

eRVR (Extended Rapid Viral Response)

After 4 and 12 weeks of treatment HCV RNA undetectable

EVR (Early Viral Response***)

After 12 weeks of treatment

> 2 logto HCV RNA decrease**

Null Responder

After 12 weeks of treatment

< 2 logio HCV RNA decrease

Partial Responder

After 24 weeks of treatment

> 2 login HCV RNA decrease but still detectable

ETR (End of Treatment Response)

At end of treatment

HCV RNA undetectable

SVR (Sustained Viral Response)

24 weeks after treatment completed

HCV RNA undetectable

Relapse

Undetectable HCV RNA at the end of treatment, but detectable sometime after treatment is stopped.

*Throughout the course of treatment, use tie same lab for HCV RNA assays so that results are comparable.
** 2 logic decrease = by factor of 102; e.g., if baseline HCV RNA = 720,000 then a 2 logto decrease is 7,200.
*** EVR is also a term for undetectable HCV RNA level after 8 weeks of treatment with a boceprevir-based regimen.

Determine the appropriate duration of therapy: Treatment duration is based on genotype, virologic response,

and

the occurrence of major side effects. See also the discussion under Monitor Treatment Response in Step 9b, in

Section 4 of the text, and the flowcharts for triple therapy and dual therapy (Appendix 4).

Duration of triple therapy is described in Step 8.

Genotype 1, 4, 5, 6: Standard duration with dual therapy = 48 weeks - If no EVR, discontinue treatment = treatment failure. - If EVR, but HCV RNA is still detectable at 12 weeks, repeat HCV RNA test at 24 weeks. If HCV RNA is
detectable at 24 weeks, discontinue treatment = treatment failure. - If significant side effects occur and RVR was achieved, can consider shortening treatment to at least 24 weeks
consultation with specialist).

still (in

Genotype 2, 3: Standard duration with dual therapy = 24 weeks - If no EVR, discontinue treatment = treatment failure.
- If significant side effects occur and RVR was achieved, can consider shortening treatment to at least 16 - 20 weeks (in consultation with specialist).

MPCH Clinical Practice Guideline: Evaluation and Treatment of Hepatitis C and Cirrhosis
12/13/2012
Page 31

Case 1:15-cv-12298-NMG Document 35-1 Filed 05/16/16 Page 32 of 43

Step 9. Manage side effects and monitor treatment response.

Guidelines for adjusting therapy for CBC changes:

Hemoglobin (Hgb)

Value

Peginterferon / Ribavirin Adjustment and Supportive Treatment

10 Ͷ 11 g/dL 8.5 Ͷ 10 g/dL

® Peginterferon -- No change. ® Ribavirin ї
- If no or minimal symptoms, then no dose modification.
- If symptomatic, decrease ribavirin by 20 mg/day. ® Peginterferon --) Reduce 50% (see note below). ® Ribavirin --> Reduce to 600 mg daily (200 mg in a.m. and
400 mg in p.m.)

Candidate for Erythropietin: Rule out other causes of anemia. If anemia persists at 2 weeks after reducing ribavirin Ͷ and there is no hypertension Ͷ then consider erythropoietin, especially if the patient demonstrates a virologic response. Erythropoietin should be considered primarily for patients who are cirrhotic, posttransplant, or HIV/HCV co-infected.
Dosage: Epoeitin alfa 40,000 units subcutaneously weekly.

< 8.5 g/dL

Typically, the entire HCV treatment regimen must be discontinued. Contact GI specialist to discuss the discontinuation of therapy.

Goal: Hemoglobin 12 g/dL.
Note: If hemoglobin is < 12 g/dL for over 4 weeks at the reduced/adjusted dose, then discontinue ribavirin.

Absolute Neutrophil Count (ANC)
Value < 750
< 500
Platelets Value < 50,000 < 30,000

Peginterferon / Ribavirin Adjustment and Supportive Treatment

LI Peginterferon Ͷ> Reduce 50% (see note below).
U Ribavirin Ͷ, No change.
Typically, the entire HCV treatment regimen must be discontinued. Contact GI specialist to discuss the discontinuation of therapy.

Granulocyte Colony Stimulating Factor (GCSF): lithe patient is responding to treatment and neutropenia persists despite reduced peghneiferon dose, consider G-CSF (in consultation with specialist) for patients who are cirrhotic, post-transplant or HIV/ HCV co-infected.
Dosage: Filgrastim 300 microgram subcutaneous daily.
Goal: ANC > 1500

Peginterferon / Ribavirin Adjustment and Supportive Treatment
Typically, the entire HCV treatment regimen must be discontinued. Contact GI specialist to discuss the discontinuation of therapy.
Typically, the entire HCV treatment regimen must be discontinued. Contact GI specialist to discuss the discontinuation of therapy.

Note: White the manufacturer of peginterferon recommends reducing dose to 50%, recent data suggest that lowering the dose to this extent may significantly reduce the likelihood of achieving an SVR. Some experts recommend a 25% dose reduction with close monitoring of hematologic parameters.
Step 10. Assess for sustained viral response (SVR).
An SVR is defined as undetectable HCV RNA at 24 weeks after treatment is completed. If HCV RNA is undetectable at the end of treatment, obtain an HCV RNA test 6 months later to assess for an SVR. Obtain a final HCV RNA test 12 months posttreatment. See Step 10 discussion in the text.

MPCH Clinical Practice Guideline: Evaluation and Treatment of Hepatitis C and Cirrhosis 12/13/2012 Page 32

Case 1:15-cv-12298-NMG Document 35-1 Filed 05/16/16 Page 33 of 43

Appendix 3. Hepatitis C Treatment Monitoring Schedule

Evaluation Clinician evaluation HIV, HBsAg, HBsAb, AntiHAV( IgG) CBC, Diffl Platelets ALT, Creatinine AST, Bilirubin, Alkaline, Phosphata.sc, Albumin, INR Uric acid (Telaprevir only) Ferritin, iron saturation, ANA* HCV RNA** HCV genotype Liver biopsy Mental health evaluation Depression Urine toxicology Visual acuity Funduscopic exam of other ophthalmologic diagnosis or diabetes) TSH. free T4 Triglycerides ECG (pre-existing CHD) Urine pregnancy test (if childbearing potential)

Baseline (Anti-HCV Positive)
X X
X X X
X

Pre-Tx X

Ongoing Monitoring (By Week of Treatment)

1 2 3 4 8 12 16 20 24 28 32 36 40 44 48

X X

XXXXX X XXXXXX

24 Weeks Post-Tx
X

X

X

X

Every 4-8 weeks during treatment

X

X

X

Every 4-8 weeks during treatment.

X

Periodically and if signs and symptoms of liver disease.

X

X

X X X

As clinically indicated.

X

X ** X

***

At end of treatment.

X

X

If indicated.

X

If indicated.

X

Assess for signs and symptoms of depression at each clinician visit.

X

If indicated.

X

X

Periodically and as clinically indicated.

12 Months Post-Tx X
X

X X If indicated. X

X

X

X

X

If indicated.

XXXXX X

X

X

X

X

X X X X X X

Monthly for six months.

* Conduct further diagnostic evaluations as clinically warranted to identify other potential causes of the patient's liver disease such as hemochromatosis. Wilson's disease, or autoirnrnune hepatitis (e.g., serum iron, serum copper, ESR). If any of these conditions are diagnosed or arc strongly suspected, a liver biopsy should be performed prior to treatment regardless of genotype. ** More HCV RNA tests may be warranted during course of treatment depending upon results of previous HCV RNA assays (see Appendices 4a, 4b, 4c, and 4d). If treating with boceprevir, an HCV RNA test should also be obtained at the end of treatment week 8.
*** An HCV RNA is obtained in all patients who are still on therapy at the end of 24 weeks. For some, this will be at the end of their treatment, e.g.. HCV genotypes

MPCH Clinical Practice Guideline: Evaluation and Treatment of Hepatitis C and Cirrhosis 12/13/2012 Page 33

Case 1:15-cv-12298-NMG Document 35-1 Filed 05/16/16 Page 34 of 43 Appendix 4a. Timeline for HCV Treatment Decisions (Based on Viral Response): Genotype 1 on Triple Therapy with Boceprevir

HCV RNA Results
clOCIU/ral at end of r2 AND
Undetectable at end ofTtric 24

! Treatment -Name )
y
HCe RNA Undetectable at. 'Ph 8
COntin6e TT
Through no; 2S

PaPrrti:o1r4R1eRlaed,e,prdoirnder

61 CV RNA Detectable at
TW a
CoritinGe Tr
Through nit: 36

Hee RNA
UncieTtVeeVta8ble at
1.`
Conti neer TT Through Tw 36

• Stop 30C afte r Tee 36 • Continue P' :2 week:.

z' "TkVs 1-8

Start L," L'a lr^n~iri W11.1% 6tly[aLA .ritelfeNA & r.boomn.:DR: clay • Chuck RCA" RNA. at end of TQV 4..f et dornue.c..t.rate., RVR, 9CV not

ad ed, but pt fecovef.....14 week,. or dual thera.coi Ef e appendix 4c)

'

Day 1 cf r Ar 5, start UDC 803 rig even/ 8 hour,.

oontrui:

*Check ACV RNA at the end of Per' li

Tmrs 9-24

i-

Centove 11 ;BCC AR; Ova HCV RNA a: end ct

----1*

Tws 12 6,24

HCV RNA Results
;:.103 ILlirnI at end of Ter 12
or Cietecrzbto at end of
TVe 2a or di 1 iog from tx nada'

Compensated Cirrhosis

STOP 4.117x atter Ea e Treatment complete

' HCV RNA

;( _

571.3 all PA atter TV146 Treatment ccrnplete

• STOr' A Tx aver nitf 36 Treatment cemp:ote

SIC*. all Tx atter rue dE Treatment compete

hi CV RNA

KEY:

-' ' ' ' ' -,

' HCe R.NA •

Tx ' ' ' ir. Fallure

•

' ' '

186C‘ Bocepreeir; 11. Triple Therapy with an kiCti Pt + aegylated interferon and ribavirin IPR); TW = Treatment Week; Tx. treatment;
(+7 c detectable HCV ANA; (-) x undetectabk Het! RNA

MPCH Clinical Practice Guideline: Evaluation and Treatment of Hepatitis C and Cirrhosis 12/13/2012 Page 34

Case 1:15-cv-12298-NMG Document 35-1 Filed 05/16/16 Page 35 of 43 Appendix 4b. Timeline for HCV Treatment Decisions (Based on Viral Response): Genotype 1 on Triple Therapy with Telaprevir

HCV RNA Res...46 51000 14.1/m1 at end of VW 4 and TW 12

ß

Start Think Therapy LIT)

Po*.tated sracrkon ß R. 3-441n
T 6.1pr Owr , 750r18 every 8 hairs

___________________________ J./

Continue TT Ior 12 wook. Chock HCV RVA atter TW 4 .and TIN 12

npr..R atter 12 week!.

Treatment-yo .ve or PFIC,T R.:441;6er

lice RNA Undetectable 31I
TW3STW12

HCV RNA Detectable but S10021U/rnlat TW 4 or TW 1.2

• Rnor 'artl.11R(spantler cr.rrnttensated Orrh066 „i/
Continuo PR 12 mare
1' neck riCV RNA
At TW 24

HCV RNA RESULTS
a100011J/miat end of Whe 4 or ß >300014J/rol at end at TW 12 nr
>1. ICS idl% from Tx

CalZi-riLk. :2 more
STOP PR 4:ter IV/ 24 Treatmert Campdt•te

V STOP PR atter TW 4S Treat-lent C6roplere
CkriKk HCV RV.A

HCV RNA (-) ETR )

.1rX

)

ß •

•

KEY:

iTvR,telapreor: Trit4 e Therapy with an HCV PI ....pegylated tnterferon and ribavirin {PR); TW o Treatinent Week: Tx= treatment.;

1.(.9 = detectable HCV RNA; andcreczable HCV RNA

1

MPCH Clinical Practice Guideline: Evaluation and Treatment of Hepatitis C and Cirrhosis 1N13/201"7
Page 35

Case 1:15-cv-12298-NMG Document 35-1 Filed 05/16/16 Page 36 of 43 Appendix 4c. Timeline for HCV Treatment Decisions Based on Viral Response: Genotypes 1, 4, 5, and 6 on Dual Therapy

...................................... Genotypes 1,4,5 & 6: Standard Treatment Duration - 48 weeks.

End of 24 Weeks

End of
OR weeks

-----

• tC,.' Viral Rewcavor C.:awgor.r,

)fundeuttablv RVR
Rapid Viral Response

If k 2 .togi., decrease: FOR
Early Viral Response**

If undetccrobiv E'fit
End of Treatment Response

24 Weeks

-

Alter treatment

completed

e'undettetobie: SVR
Sustained Kral Response

4 Week NCV RNA

.Treatment Recommendations Based on Viral Response.

32 Week ACV RNA

Undetectable

Continue Ix*

EVR

at 12 week.

A

44 Week HCV RNA

JeteCtazio ;at 12 wei4z.

L.

At 24 week;

ME=

24 Week HCV RNA

24 Weeks after Treatment is
CompletedHCV RNA

DetectabJe

At

24

,
w,' Ck5

STOP All
Therapy!

slop
AR Trwrapyi

Treatment • Complete'

IC=

MEM

LI

;e4;:-...-it .bire,:ks "IC hieve.d.

thr tieazintrr-, :0 at 24

• '2

4.Nrexxr by a incur 0! IQ' r100). baSa

load 72,3007.ht'il 2 to aecrea-w. 7200.

""R/JA Win cktecttialv at 4 va.elz., 4ndier at 12 WedC., ...uctenOtrq;.' thk-rApytc 72 v.\•ca>hauiC by conl<d‹,red.

00, t,e

rcatrrunt ,ur
wah

MPCH Clinical Practice Guideline: Evaluation and Treatment of Hepatitis C and Cirrhosis 12/13/20i2 Page 36

Case 1:15-cv-12298-NMG Document 35-1 Filed 05/16/16 Page 37 of 43 Appendix 4d. Timeline for HCV Treatment Decisions Based on Viral Response: Genotypes 2 and 3 on Dual Therapy

"IC' V=.1",)1 kc-000r*e Catecones Ancro.ra: Treat; no,•4
-2

End of 4 Weeks

Genotypes 2 and 3: Standard Treatment Duration = 24 weeks.

Ent of 12 Weeks

End of 6.20

End at 7.4 Weeks

24 Weeks After treatment

if amcierecabfe:
FAIR Rapid Viral Response

Vagy,derafease:
fttii Eato Vital Response'

f urbdetraardc: LIR
End of Treatment Response

If uncle:40.4We: SVR.
Sustained viral Resprmse

a Week HCV RNA
RVR or no Ft1.‘R
Con :nue Treatment rt-cartiked re u32z

Treatment Recommendations Based on Viral Response.

12 Week liCV RNA

EVR

)0. Continue Treatment

ZS Week HCV RNA

No -VP

— — — it liipiticant siclo effect, cocur, and the Patienk has an RVR at 4 week., Men, a 0144-ter treat.! . 1,,,nt
weekz. can 6s- I considered, in censwItation with an I expert
Ri\.4 16-20 Weeks

ETe

fTk

STOP 411

Treatment \s, Complete**

24 weeks after Treatment is CompletedHCV RNA Undetecabte
Ce:r.c-ct.,:A LA!

FIR

factQr

i1 oyct3ne 'oral c eJ = 720,CM N4,-n Z top, decrerzo.1130.

yr Therapy!
Trearm.6')e Failure

r Treatnent
Faihre

MPCH Clinical Practice Guideline: Evaluation and Treatment of Hepatitis C and Cirrhosis 12/13/2012 Page 37

Case 1:15-cv-12298-NMG Document 35-1 Filed 05/16/16 Page 38 of 43

Appendix 5. Interferon I Ribavirin Drug Information

Peginterferon
Descriptions: A long-acting, synthetic interferon that is indicated for use alone or in combination with ribavirin for the treatment of chronic Hepatitis C, or with ribavirin and an HCV protease inhibitor for treatment of chronic HCV genotype I.
Formulations: Peginterferon alfa-2b (Peg-Intron®)

Standard Dosing:
Peg-Intron® is administered subcutaneously, once weekly. The dosing below is based on recommended dose of 1.5 micrograms (meg) per kilogram per week (regardless of HCV genotype). It comes in four different vial strengths; utilize the appropriate vial strength related to the inmate's weight.

Body Weight (Pounds)
< 88 88 Ͷ 111 112 Ͷ 133 134Ͷ 144 145 Ͷ 166 167 Ͷ 177 178Ͷ 187 188 Ͷ 231
> 231

Vial Strength (mcg/0.5mL)
50 80 80 120 120 120 120 150 150

Dose to Administer (1.5 mcgikg/wk)
50 64 80 96 96 120 120 150 150

Volume to Administer (mi.)
0.5 0.4 0.5 0.4 0.4 0.5 0.5 0.5 0.5

Ribavirin

A nucleoside analogue with antiviral activity. It is used in conjunction with peginterferon for treatment of Hepatitis C. Ribavirin should not be used alone as monotherapy for Hepatitis C.

Several formulations of 200 mg tablets or capsules are available for oral administration, including two brand-name versions: Copegus® and Rebetol®. The generic versions are less expensive and equivalent to the branded drugs.

In Genotypes 1, 4, 5, and 6 ribavirin dosing is weight-based:

Body Weight (Pounds)

Every AM

Every PM

<88

400

400

88 Ͷ 111

400

400

112 Ͷ 133

400

400

134Ͷ t44

400

400

145Ͷ 166

400

600

167 Ͷ 177

400

600

178 Ͷ 187

600

600

188-231

600

600

>231

600

600

In Genotypes 2 and 3 a total daily dose of 800 mg is administered as 400mg orally twice daily (regardless of weight).

Dosing In Certain Clinical Circumstances:
Renal Dysfunction ¸ Peg-Wrongs: In inmates with moderate renal function (CrCI of 30-50 mL/min), the Peg-lntron dose should be reduced by 25%. If severe
renal function impairment (CrCI 10-29 mL/min), including hemodialysis, reduce dose by 50%. If renal function decreases during treatment, discontinue treatment. ¸ Ribavirin is not indicated in inmates with a CrCI <50 milmin.

Hemodialysis ¸ Peg-IntronO: Reduce dose br 50%. ¸ Ribavirin is not indicated.

HIV/HCV Co-infection ¸ Treat for 48 weeks, regardless of genotype. See Section 4.
Contraindications:
‫ ݱ‬Severe uncontrolled psychiatric disease, particularly depression with current suicidal risk.
‫ ݱ‬History of solid organ transplant (renal, heart, or lung) ‫ ݱ‬Certain autoimmune disorders, e.g., autoimmune Hepatitis ‫ ݱ‬Uncontrolled endocrine disorders, e.g., diabetes, thyroid

V Thalassemia or other hemoglobinopathy ‫ ݱ‬Significant cardiac disease (arrhythmias, angina, CABG, MI)
in the past 12 months ‫ ݱ‬Pregnancy or unwillingness to use contraception in both
female inmates and in female partners of male inmates.

MPCH Clinical Practice Guideline: Evaluation and Treatment of Hepatitis C and Cirrhosis 12/13/2012 Page 38

Case 1:15-cv-12298-NMG Document 35-1 Filed 05/16/16 Page 39 of 43

Peginterferon disease V Serious concurrent medical diseases such as: severe hypertension, heart failure, CHD, COPD, decompensated cirrhosis (see definition) V Platelet count <75,000/rnin3 or ANC <1,500 cells/1111113 V Documented nonadherence to prior therapy, or failure to complete pretreatment evaluation process V Ongoing injection drug use or alcohol use V Hypersensitivity to interferon
Major Side Effects:
May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders.
Side Effects:
¸ Autoimmune disorders: Can result in development or exacerbation of disorders
¸ Bone marrow suppression: Can cause severe cytopenias (see Appendix 2, Step 9a)
¸ Cardiovascular disorders: Hypertension, arrhythmias, and myocardial infarction
¸ Cerebrovascular disorders: Ischemic and hemorrhagic cerebrovascular events
¸ Colitis: Ulcerative and hemorrhagic/ischemic colitis, sometimes fatal
¸ Dermatologic effects: Alopecia, pruritis, and local injection site reaction
¸ Endocrine disorders: Hypo- or hyperthyroidism, hypo- or hyperglycemia & diabetes
¸ Flu-like symptoms: Fever, myalgia, fatigue, headache ¸ Gastrointestinal effects: Nausea, vomiting, diarrhea, and
anorexia ¸ Hypersensitivity (anaphylaxis and angioedema): Severe and
acute ¸ Infections (bacterial, fungal, and viral): Can be severe and
sometimes fatal ¸ Hepatic failure and Hepatitis exacerbations with hepatic
decompensation and death ¸ Neuropsychiatric symptoms: Life threatening or fatal
neuropsychiatric reactions ¸ Ophthalmologic disorders: Loss of vision, retinopathy
including macular edema ¸ Pancreatitis: Sometimes fatal ¸ Pulmonary disorders: Dyspnea, pulmonary infiltrates,
pneumonia, and sarcoidosis ¸ Renal failure ¸ Seizures ¸ Triglyceride elevations

Ribavirin V. Renal dialysisSerum creatinine =1.5 IngidL or creatinine
clearance Ͷ50 mLimin V Hemoglobin <12 g/dL in men or <II g/dL in women V Hypersensitivity to ribavirin
Has a primary clinical toxicity of hemolytic anemia. Since ribavirin-associated anemia has been known to lead to myocardial infarction, it is contraindicated in imnates with significant or unstable cardiac disease. Significant teratogenic effects have been noted in all animal species exposed to ribavirin. Pregnancy should be prevented during therapy, and for the six months after the completion of therapy, in both female inmates and female partners of male inmates.
Black Box Warnings:
¸ Hemolytic Anemia Warning (primarily in the first two weeks of therapy)
¸ Pregnancy Warning (negative pregnancy test is required pretherapy)
¸ Respiratory Warning for inmates requiring assisted
Additional Side Effects: ¸ Cardiovascular effects: Fatal and non-fatal myocardial
infarction ¸ Dermatologic effects: Alopecia, pruritis, and rashes ¸ Flu-like symptoms: Myalgia, fatigue, and headache ¸ Gastrointestinal effects: Nausea, anorexia, and vomiting ¸ Hetnatologic: Neutropenia and thrombocytopenia (see
Appendix 2, Step 9a) ¸ Hepatic decompensation and death ¸ HypersensitivityͶacute: Anaphylaxis, angioedema, and
bronchoconstriction ¸ Pulmonary symptoms: Dyspnea, pneumonia, and pulmonary
infiltrates ¸ Teratogen (significant), carthogenesis, and mutagenesis

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Case 1:15-cv-12298-NMG Document 35-1 Filed 05/16/16 Page 40 of 43

Appendix 6. Boceprevir / Telaprevir Drug Information

Boceprevir Descriptions: An oral medicine that acts directly on the Hepatitis C virus protease, an enzyme essential for viral replication. Boceprevir should always be taken in combination with peginterferon alfa and ribavirin. Boceprevir should not be used alone as monotherapy for Hepatitis C. Formulations: Boceprevir (VictrelisTM) is manufactured as 200 mg oral capsules that are packaged in daily dosage bottles of 12 capsules each. The dose for boceprevir is 800 mg (four 200 mg capsules) three times daily (every 7-9 hours), taken with food (a meal or light snack).
Standard Dosing: Boceprevir has been approved for administration according to a specific response-guided therapy algorithm (see Appendix 4). Therapy is initiated with peginterferon and ribavirin for the first 4 weeks of treatment (peginterferon/ribavirin "lead in" period) prior to adding boceprevir.
Weeks 1-4:
- Peginterferon (Peglntron 1.5 meg/kg/week) and - Ribavirin (in 2 divided doses) with food

Telaprevir
An oral medicine that acts directly on the Hepatitis C virus protease, an enzyme essential for viral replication. Telaprevir should always be taken in combination with peginterferon alfa and ribavirin. Telaprevir should not be used alone as monotherapy for Hepatitis C.
Telaprevir (IncivekTM) is manufactured as 375 mg tablets that are packaged into cartons containing a four-week supply: 4 weekly blister cards, with each card consisting of 7 daily blister strips of 6 tablets each. The dose for telaprevir is 750 mg (two 375 mg tablets) three times daily (every 7-9 hours), with each dose taken 30 minutes after eating a meal or snack that contains at least 20 grams of fat.
Telaprevir is dosed 750 mg orally (2 x 375 mg tablets) every 8 hours (+/Ͷ lhr) with food (containing a minimum of 20g of fat) for 12 weeks, plus:
- Peginterferon (Peglntron 1.5 mcg/kg/week) and - Ribavirin (in 2 divided doses) with food
Refer to Appendix 5 for appropriate dosing of peginterferon and ribavirin.

Refer to Appendix 5 for appropriate dosing of peginterferon and ribavirin.
Beginning at Week 5:
- Boceprevir 800 mg orally (4 x 200 mg capsules) every 8 hrs (+1-1 hour) with food plus peginterferon and ribavirin.

Total treatment duration is guided by on-treatment HCV RNA response and inmate characteristics, as described in telaprevir treatment algorithm (see Appendix 4).

Total treatment duration is guided by on-treatment HCV RNA response and inmate characteristics, as described in boceprevir treatment algorithm (see Appendix 4).
Dosing and Treatment Duration in Triple Therapy:
The first 8 weeks of treatment are the same for all boceprevirbased regimens, as follows:
Start therapy with a 4-week lead-in period of dual therapy, using standard doses of pegylated interferon and ribavirin. Boceprevir is added to the regimen after 4 full weeks of dual therapy, and pegylated interferon and ribavirin are continued. In other words, treatment week 5 is the first week of triple therapy.

The telaprevir-based regimen starts with all three medications, all of which are continued for12 weeks. After 12 weeks, telaprevir is discontinued while pegylated interferon and ribavirin are continued for an additional 12 weeks (24 weeks total) or an additional 36 weeks (48 weeks total).
Telaprevir dose is 750 mg (two 375 mg tablets) by niout every 8 hours (+/- 1 hour) with a 20-gram fat snack.

Boveprevir dose is 800 mg (four 200 mg capsules) by moot every 8 HCV RNA levels are obtained at the end of treatment weeks 4, 12,

hours (+/- 1 hour) with food/light snack.

24 and at the end of treatment. (-) means undetectable HCV

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Case 1:15-cv-12298-NMG Document 35-1 Filed 05/16/16 Page 41 of 43

Boceprevir
HCV RNA levels are obtained at the end of treatment weeks 4, 8, 12, 24 and at the end of treatment. (-) means undetectable HCV RNA levels; (+) means detectable, but < 100 IU/ml.
Four different treatment durations are possible, as described in Appendix 2, Step 8.

Telaprevirͻ RNA levels; (+) means detectable, but < 1000 IU/ml.
Discontinue all HCV medications if any of the following occur: RNA > 1000 1U/m1 at treatment week 4 or 12, RNA detectable at treatment week 24, while on treatment, HCV RNA increases by 1 logio above treatment nadir.

Discontinue all HCV medications if any of the following occur: RNA >
100 whim at treatment week 12, RNA detectable at treatment
week 24, while on treatment, HCV RNA increases by 1 logio above treatment nadir.

Dosing In Certain Clinical Circumstances: ''
Renal Impairment No dosage adjustment of boceprevir or telaprevir is necessary for inmates with " mild, moderate, or severe renal impairment; telaprevir was not studied in inmates with end-stage renal disease or on hemodialysis.

HBV/HCV Co-Infection
No safety or efficacy data are available in this population. Treatment with telaprevir or boceprevir for Hepatitis C is not indicated and has not been approved for inmates co-infected with HBV.

Contraindications* -..

¸ All contraindications to peginterferon alfa and ribavirin, since boceprevir must be administered with peginterferon alfa and ribavirin
¸ Pregnant women and men whose female partners are pregnant, because ribavirin may cause birth defects and fetal death
¸ Decompensated cirrhosis ¸ Co-infection with HBV or HIV ¸ Solid organ transplant recipient ¸ Co-administration with drugs that are highly dependent on
CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or lifethreatening events, e.g., AlfUzosin, Ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), cisapride, some statins (simvastatin, lovastatin), drosperinone, PDE5 enzyme Inhibitors (sildenafil, tadalafil), pimozide, triazolam , and orally administered midazolam
¸ Co-administration with drugs that strongly induce CYP3A, which may lead to lower exposure and loss of efficacy of boceprevir, e.g,. certain anticonvulsants (carbamazepine, phenobarbital, phenytoin), rifampin, and St. John's wort

¸ All contraindications to peginterferon alfa and ribavirin, since telaprevir must be administered with peginterferon alfa and ribavirin
¸ Pregnant women and men whose female partners are pregnant, because ribavirin may cause birth defects and fetal death
¸ Decompensated cirrhosis ¸ Co-infection with HBV or HIV ¸ Solid organ transplant recipient ¸ Co-administration with drugs that are highly dependent on
CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or lifethreatening events, e.g., Alfuzosin, Ergot derivatives (dihydroergotainine, ergonovine, ergotamine, methylergonovine), cisapride, some statins (atorvastatin, simvastatin, lovastatin), PDE5 enzyme inhibitors (sildenafil, tadalafil), pimozide, triazolam , and orally administered midazolam
¸ Co-administration with drugs that strongly induce CYP3A, which may lead to lower exposure and loss of efficacy of teleprevir, e.g,. rifampin and St. John's wort

Use With Caution:
The following medications may pose risk for potential interaction with boceprevir that may require close monitoring, alteration of drug dosage, or timing of administration:
¸ Analgesics (buprenorphine, methadone) ¸ Antiarrhythmis (amiodarone, bepridil, digoxin, flecainide,
lidocaine, propafenone, quinidine) ¸ Antibacterials (clarithromycin, erythromycin, rifabutin,
telithromycin) ¸ Antidepressants (desipramine, escitalopram, trazodone)

The following medications may pose risk for potential interaction with telaprevir that may require close monitoring, alteration of drug dosage, or timing of administration:
¸ Analgesics (buprenorphine, methadone) ¸ Antiarrhythmics (amiodarone, bepridil, digoxin, flecainide,
lidocaine, propafenone, quinidine) ¸ Antibacterials (clarithromycin, erythromycin, rifabutin,
telithromycin) ¸ Anticonvulsants (carbamazepine, phenobarbital, phenytoin)

MPCH Clinical Practice Guideline: Evaluation and Treatment of Hepatitis C and Cirrhosis
12/13/2012
Page 41

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Boceprevir
俵 Antifimpls (itraconazole, ketoconazole, posaconazole, voriconazole)
俵 Antipsychotics (clozapine) 俵 Anxiolytics/hypnotics/sedatives (alprazolam, parenteral
midazolam, zolpidem) 俵 Bronchodilators (salmeterol) 俵 Calcium channel blockers (amlodipine, diltiazem, felodipine,
nicardipine, nifedipine, nisoldipine, verapamil) 俵 Contraceptives/hormonal replacement (ethinyl estradiol,
norethindrone)
俵 Erectile dysfunction agents (sildenafil, tadalafil, vardenafil) 俵 Gastrointestinal agents (cimetidine, ranitidine) 俵 HIV dnigs (maraviroc, delavirdine, efavirenz, etravirine,
nevirapine, zidovudine, atazanavir, daninavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir) 俵 Immunosuppressants (cyclosporine, sirolimus, tacrolimus) 俵 Lipid-lowering agents (atorvastatin) 俵 Steroids (budesonide, dexamethasone, fluticasone, methylprednisolone, prednisone) 俵 Other drugs (bosentan, colchicine, warfarin)

Telaprevir
‫ ݱ‬Antidepressants (desipramine, escitalopram, trazodone) ‫ ݱ‬Antifbngals (itraconazole, ketoconazole, posaconazole,
voriconazole)
‫ ݱ‬Antipsychotics (clozapine)
‫ ݱ‬Anxiolytics/hypnotics/sedatives (alprazolam, parenteral midazolam, zolpidem)
‫ ݱ‬Bronchodilators (salmeterol) ‫ ݱ‬Calcium channel blockers (amlodipine, diltiazem, felodipine,
nicardipine, nifedipine, nisoldipine, verapamil) ‫ ݱ‬Contraceptives/hormonal replacement (drospirenone, ethinyl
estradiol, norethindrone) ‫ ݱ‬Erectile dysfunction agents (sildenafil, tadalafil, vardenafil)
‫ ݱ‬Gastrointestinal agents (cimetidine, ranitidine)
‫ ݱ‬HIV drugs (maraviroc, delavirdine, efavirenz, etravirine, nevirapine, tenofovir, zidovudine, atazanavir, dar" navir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir)
‫ ݱ‬Immunosuppressants (cyclosporine, sirolimus, tacrolimus) ‫ ݱ‬Steroids (budesonide, dexamethasone, fluticasone,
methylprednisolone, prednisone)
‫ ݱ‬Other drugs (bosentan, colchieine, warfarin)

Side Effects:
俵 Dermatologic effects: Pruritis 俵 Flu-like symptoms: Myalgia, fatigue, and headache 俵 Gastrointenstinal effects: Dysgeusia, nausea, anorexia, and
vomiting
俵 Hematologic: • Anemia: The addition of boceprevir to peginterferon alfa and ribavirin (PEG/riba) is associated with an additional decrease in hemoglobin concentrations. • Neutropenia: The addition of boceprevir to PEG/riba is associated with an additional decrease in neutrophil counts. Decreases in neutrophil counts may require dose reduction or discontinuation of PEG/riba. No dose adjustment should be made to boceprevir. If PEG/riba is discontinued, boceprevir should be discontinued and not restarted (see Appendix 2, Step 9).

‫ ݱ‬Hematologic effects: Anemia; the addition of telaprevir to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations (see Appendix 2, Step 9).
‫ ݱ‬Dermatologic effects: Rash with or without pn" ritis
‫ ݱ‬Flu-like symptoms: Myalgia, fatigue, headache
‫ ݱ‬Gastrointestinal effects: Dysgeusia, nausea, vomiting, diarrhea, and auorectal discomfort, anal pn" ritis, hemorrhoids

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Case 1:15-cv-12298-NMG Document 35-1 Filed 05/16/16 Page 43 of 43
Appendix 7. Resources
Health Care Professionals American Association for the Study of Liver Diseases http://www.aasld.org/Pages/Defaultaspx Centers for Disease Control and Prevention National Center for Infectious Diseases Ͷ Hepatitis Branch http://www.cdc.govincidod/diseases/Hepatitis/ MELD Score Calculator littp://optn.transplant.hrsa.goviresources/IvIeldPeldCalculator.asp?index=98 National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases http://www.niddk.nih.gov National Clinicians' Post-Exposure Prophylaxis PEPline: (888) 448-4911 http://www.nccc.ucstedu/ U.S. Department of Veterans Affairs National Hepatitis C Program http://www.Hepatitis.va.gov/
inmates American Liver Foundation (ALF) \\ WW. liverfoundation.org Centers for Disease Control and Prevention (CDC) www.cde.gov/idtt/Hepatitis/index.htm Hepatitis Foundation International (RFD wmv.hepfi.org The National Digestive Diseases Information Clearinghouse (NDDIC) http://wmv.digestive.niddk.nih.goviddiseases/pubs/hepcez/index.htm U.S. Department of Veterans Affairs National Hepatitis C Program Ͷ For Veterans and the Public www.Hepatitis.va.gov/inmate/index.asp

MPCH Clinical Practice Guideline: Evaluation and Treatment of Hepatitis C and Cirrhosis

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The Management of Hepatitis C Treatment in Massachusetts State Correctional Facilities
An Update and Analysis of the Current HCV Database
A Major Qualifying Project Report submitted to the faculty of WORCESTER POLYTECHNIC INSTITUTE
in partial fulfillment of the requirements for the Degree of Bachelor of Science Submitted by:
Kathryn Carpenter Danielle Sorenson
April 26, 2007
Advised by: Professor Jill Rulfs Department of Biology and Biotechnology

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Abstract
In 2004, a database was implemented to assess the treatment of inmates infected with hepatitis C in Massachusetts state correctional facilities. The purpose of this project was to update the database and examine the current treatment system. Inmate demographics, treatment success, and viral characteristics were assessed and analyzed for potential correlations. Recommendations to improve the database included focusing on the collection of missing data, namely the inmate’s history of substance abuse and health conditions and follow up viral load measures.
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Acknowledgements
We would like to express our gratitude to Carol Bova at the UMass Graduate School of Nursing for giving us the opportunity to be a part of this ongoing project. Her guidance and willingness to help throughout the course of this project will always be appreciated. We would also like to thank Verdene Coleman-Smith from the UMass Correctional Health Program whose assistance and efforts made this project possible. We would like to give a special thanks to Jill Rulfs whose commitment to help was a constant source of encouragement.
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Table of Contents
ABSTRACT ........................................................................................................................ I
ACKNOWLEDGEMENTS ............................................................................................ II
WHAT IS HEPATITIS C? .............................................................................................. 1
TYPES AND SYMPTOMS .................................................................................................... 1 TESTING AND DIAGNOSIS................................................................................................. 2 TREATMENT..................................................................................................................... 3 EPIDEMIOLOGY ................................................................................................................ 5 HCV IN CORRECTIONAL FACILITIES ................................................................................ 6 MANAGEMENT STRATEGIES FOR CORRECTIONAL SETTINGS............................................ 8
Prevention and Education........................................................................................... 8 Screening..................................................................................................................... 9 Mental Illness and Substance Abuse........................................................................... 9 Challenges................................................................................................................... 9 THE CURRENT EVALUATION AND MANAGEMENT PRACTICES FOR THE TREATMENT OF HEPATITIS C IN MASSACHUSETTS CORRECTIONAL FACILITIES ...................................... 10 Screening for Treatment Eligibility .......................................................................... 11 Pre-treatment Protocol ............................................................................................. 11 The Process of HCV Therapy ................................................................................... 13 Inmates Co-infected with HIV and HCV................................................................... 13 The HCV Database ................................................................................................... 17
MATERIALS AND METHODS ................................................................................... 19
RESEARCH PREPARATION .............................................................................................. 19 DATA COLLECTION........................................................................................................ 19 DATA ENTRY ................................................................................................................. 20 DATA ANALYSIS ............................................................................................................ 20
RESULTS ........................................................................................................................ 22
INMATE CHARACTERISTICS............................................................................................ 22 Facility at Start of Treatment.................................................................................... 22 Gender....................................................................................................................... 24 Race........................................................................................................................... 25 Age ............................................................................................................................ 26 HCV Genotype .......................................................................................................... 28
RESPONSE TO TREATMENT............................................................................................. 29 Baseline ALT Levels.................................................................................................. 29 HCV Viral Load ........................................................................................................ 31 Correlation between HCV Genotype and Success of Treatment .............................. 32 HIV Co-infection....................................................................................................... 32 Correlation between HIV Co-infection and Success of Treatment........................... 33 Treatment Interruptions ............................................................................................ 34 Early Discontinuation of Treatment ......................................................................... 34
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Case 1:15-cv-12298-NMG Document 35-4 Filed 05/16/16 Page 5 of 67 DISCUSSION .................................................................................................................. 36
CHARACTERISTICS ......................................................................................................... 36 TREATMENT OUTCOMES ................................................................................................ 38 IMPORTANCE OF DATABASE........................................................................................... 43 RECOMMENDATIONS...................................................................................................... 44 REFERENCES................................................................................................................ 46 APPENDIX A: COPY OF THE CURRENT HEPATITIS C WORKSHEET ........ 49 APPENDIX B: “INMATE AGREEMENT” FORM .................................................. 51 APPENDIX C: EXAMPLE OF AN ORIGINAL INMATE TREATMENT
RECORD ............................................................................................. 52 APPENDIX D: COPY OF FIRST DATA COLLECTION FORM .......................... 54
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List of Figures
FIGURE 1: DISTRIBUTION OF INMATES AMONG MASSACHUSETTS STATE CORRECTIONAL FACILITIES AT THE START ................................................................................ 24
FIGURE 2: DISTRIBUTION OF MALE AND FEMALE INMATES TREATED............................... 25 FIGURE 3: RACE/ETHNICITY OF INMATES TREATED .......................................................... 26 FIGURE 4: AGE DISTRIBUTION AT START OF TREATMENT................................................. 28 FIGURE 5: DISTRIBUTION OF HCV GENOTYPES AMONG INMATES TREATED..................... 29 FIGURE 6: DISTRIBUTION OF ALT LEVELS AT THE START OF TREATMENT........................ 31 FIGURE 7: DISTRIBUTION OF INMATES WITH HIV/HCV CO-INFECTION ............................ 33
List of Tables
TABLE 1: FREQUENCY AND PERCENTAGE OF INMATES AMONG MASSACHUSETTS STATE CORRECTIONAL FACILITIES................................................................................................ 23
TABLE 2: FREQUENCY AND PERCENTAGE OF MALE AND FEMALE INMATES TREATED...... 24 TABLE 3: FREQUENCY AND PERCENTAGE OF RACE/ETHNICITY AMONG INMATES
TREATED............................................................................................................ 26 TABLE 4: AGE OF INMATES AT THE START OF TREATMENT............................................... 27 TABLE 5: FREQUENCY AND PERCENTAGE OF HCV GENOTYPES AMONG INMATES
TREATED............................................................................................................ 28 TABLE 6: BASELINE ALT LEVELS AMONG INMATES TREATED ......................................... 30 TABLE 7: UNDETECTABLE VIRAL LOADS AMONG INMATES TREATED .............................. 32 TABLE 8: THE EFFECT OF HCV GENOTYPE ON HCV VIRAL LOADS ................................. 32 TABLE 9: FREQUENCY AND PERCENTAGE OF INMATES CO-INFECTED WITH HIV .............. 33 TABLE 10: THE EFFECT OF HIV CO-INFECTION ON HCV VIRAL LOADS........................... 34 TABLE 11: NUMBER OF INMATES WHO EXPERIENCED TREATMENT INTERRUPTIONS........ 34 TABLE 12: EARLY DISCONTINUATION OF TREATMENT AMONG INMATES ......................... 35
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What is Hepatitis C?
By definition, hepatitis is an “inflammation of the liver” (Merriam-Webster Incorporated, 2006). It is a gastroenterological disease that results in damage to the liver cells, and depending on the severity, may even destroy them. There are a number of different types of hepatitis which can be caused by a variety of factors including other illnesses or diseases, noninfectious substances such as drugs, alcohol, or toxic chemicals, and infectious agents such as viruses or parasites (Encyclopedia Britannica, Inc., 2007). In the most common cases, hepatitis is the result of a viral infection.
Hepatitis C is one of six currently identified types of viral hepatitis (A, B, C, D, E, and G). It has become a major health concern in the United States, today, is one of the leading causes of liver disease, and a major reason for liver transplants (Jetter, 2005). True to its name, hepatitis C is a blood borne disease of the liver caused by the hepatitis C virus (HCV), a single-stranded RNA virus of the family Flaviviridae. HCV can be categorized into six major genotypes and more than 50 subtypes. Genotypes range in geographic distribution and response to treatment, but show little difference in the severity of the disease or outcome. The most common genotypes in the US are 1a and 1b, which account for over 70% of the cases (National Digestive Diseases Information Clearinghouse [NDDIC], 2006).
Characteristic of a blood borne infection, HCV is carried through the blood and transmitted primarily via contact with infected blood and blood products (NDDIC, 2006). Major risk factors associated with the transmission of HCV include blood transfusions and transplants, injection or use of illegal drugs, occupational exposure (i.e. healthcare workers), high risk sexual behavior with an infected partner, and non-sterile instrument use for tattoos or body piercing (Centers for Disease Control and Prevention [CDC], 1998). HCV may not be transmitted through casual contact with an infected person and is rarely acquired through maternal-infant transmission or household contact with infected blood or fluids. At present, injection drug use is the most common form of HCV transmission in the United States (NDDIC, 2006).
Types and Symptoms
Hepatitis C is typically categorized into one of two stages: acute hepatitis C or chronic hepatitis C. Each stage refers to the current progression of the viral infection and depends upon the length of infection time and the severity of the disease. In either case, HCV poses a potential number of dangers to the liver.
Acute hepatitis C is used to describe the first six months of infection, during which the liver is first attacked by HCV, liver inflammation initiates, and liver enzyme levels begin to rise. Persons with acute infections are usually asymptomatic and unaware of the virus they are carrying. Those who do develop symptoms exhibit mild, nonspecific flu-like signs such as fatigue, sore muscles, headaches, nausea, and loss of appetite, and in some cases, may also acquire jaundice (Jetter, 2005). These symptoms usually do not develop until 6-7 weeks after infection and are often mistaken for other medical conditions or disappear before raising any serious concern. According to studies and organizations such as the National Institute of Diabetes and Digestive and Kidney Diseases, between 75% and 85% of those with acute hepatitis C will eventually progress
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into a more severe, long-term chronic form of hepatitis C due to a lack of treatment or failure to respond to treatment within the first six months (CDC, 1998).
Chronic hepatitis C is defined as an HCV infection that has progressed beyond six months. It the most commonly diagnosed form of hepatitis C and is a major cause of cirrhosis, liver failure, and liver cancer (Liang, Rehermann, Seef, & Hoofnagle, 2000). Depending upon the severity of the infection, chronic hepatitis C varies greatly among patients in its course and outcome. For instance, those with mild chronic hepatitis C typically have no signs or symptoms of liver disease and exhibit rather minor damage to the liver. On the other hand, those patients with severe chronic hepatitis C demonstrate high levels of HCV virus in the blood, elevated liver enzyme levels (indicating liver disease), severe physical damage to the liver, and more specific symptoms such as muscle weakness, weight loss, itching, dark urine, fluid retention, and abdominal swelling. The majority of these patients will ultimately develop cirrhosis and end-stage liver disease. For the many patients who fall in the middle of the spectrum, chronic HCV infection is characterized by mild to moderate elevations in liver enzymes and few or no symptoms. In 1-2% of patients, chronic hepatitis C can cause complications outside the liver known as extrahepatic manifestations. These may include such conditions as cyroglobulinemia, glomerulonephritis, and porphyria cutanea tarda (NDDIC, 2006).
Despite the potential dangers of HCV infection, hepatitis C lies dormant in most patients for years. Statistics have shown that as many as 70% of those infected with HCV are unaware of the virus and more than half show no signs or symptoms of HCV infection. (Jetter, 2005; Henkel, 1999) In fact, hepatitis C is frequently not recognized until infected individuals undergo blood-donor screenings that are positive for HCV or routine physical exams that show elevated liver enzyme levels (CDC, 1998).
Testing and Diagnosis
Persons suspected to have an HCV infection must undergo a number of blood tests before they can be diagnosed with hepatitis C. Blood tests range in specificity and are designed to test for indicators of an HCV infection, HCV antibodies, and the HCV virus itself.
One of the most frequent indicators of a potential HCV infection is elevated levels of liver enzymes, or more specifically, alanine aminotransferase (ALT). Most people infected with HCV exhibit elevated levels of liver enzymes, such as ALT, on a routine blood test within 50 days of exposure (Jetter, 2005). Although not all infected patients show signs of alteration in their ALT levels, persistently abnormal levels of ALT are fair indicators that an infection may be present and that further tests should be conducted. ALT tests are not designed to confirm HCV infection, but are rather a nonspecific means of initially screening for infection (Herrine, 2002).
To determine whether or not an HCV infection is actually present, individuals are screened for the presence of HCV antibodies (anti-HCV) using a series of U.S. Food and Drug Administration (FDA) approved diagnostic tests (CDC, 1998). Anti-HCV is usually present in the blood of infected individuals within one month of exposure to the virus (NDDIC, 2006). If hepatitis C is suspected based on symptoms and/or ALT levels, an enzyme immunoassay (EIA) is first conducted and then later confirmed by a supplementary recombinant immunoblot assay (RIBA), a western blot specific for antiHCV. Two positive results indicate an HCV infection, while two negative results
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indicate no infection. Indeterminate results are usually indicative of a recently infected person, a person with chronic HCV, or poor testing. Anti-HCV test results do not characterize the type of hepatitis C or distinguish between patients with an acute, chronic, or recently treated infection (CDC, 1998).
In most patients, hepatitis C viral RNA can be detected within one to two weeks of HCV infection, long before the presence of anti-HCV or elevated ALT levels (CDC, 1998). As further confirmation of an active HCV infection, qualitative and quantitative assays can be done to detect the presence or absence of HCV RNA. Qualitative assays, such as the polymerase chain reaction (PCR) and transcription-mediated amplification (TMA) are usually done to determine whether or not HCV RNA is present in the serum. Quantitative assays, on the other hand, are conducted as indirect assessments of the amount of HCV RNA present in the blood. These viral loads determined by assays such as quantitative RT-PCR and branched DNA signal amplification do not directly correlate with the severity of hepatitis C, but are a good indication of the likelihood of a response to antiviral therapy (NDDIC, 2006).
In the majority of cases, elevated ALT levels and the presence of anti-HCV in the blood serum is enough to diagnose an individual with hepatitis C. Additional testing is typically done to either confirm the diagnosis or characterize the infection in preparation for treatment. Genotyping and liver biopsies are common examples of characterization tests performed to determine the genotype of the hepatitis C virus and the severity of the infection, respectively. Tests, like these, are good indicators of how a patient will respond to different treatments and which treatment will work best (NDDIC, 2006). Some states have also found these tests, particularly the liver biopsy, to be cost effective. In 2004, the Virginia Department of Corrections offered all inmates who tested positive for HCV RNA the opportunity to get a liver biopsy. This approach allowed physicians to avoid unnecessary treatment by treating only those inmates in the advanced state of the disease. It was estimated that liver biopsies saved almost $125,000 per 100 patients (Sterling, 2003).
Treatment
Presently, there is no cure or vaccine for hepatitis C. Like most viruses that cause chronic conditions, HCV RNA mutates very rapidly inside the human body. HCV infection elicits some response from the immune system early on, but constant mutations essentially allow the virus to evade the immune system over time and inhibit the development of preventative drugs (NDDIC, 2006). Consequently, the only options available for patients today are moderately successful treatments aimed at the elimination of detectable virus in the blood serum. Success of treatment is usually measured in terms of sustained virologic response, which can be defined as “the absence of HCV RNA in the serum during therapy and six months after completion of therapy” (Herrine, 2002).
Effective treatment for hepatitis C first began over 10 years ago, when alpha interferon was approved for treatment of non-A and non-B hepatitis in 1991 (Herrine, 2002). Treatment required that the antiviral protein be injected subcutaneously at least three times a week for approximately 12 months. Initial results indicated normalized ALT levels and a loss of detectable HCV RNA in the serum of most patients by the end of the therapy. However, long term studies of treatment with alpha interferon have
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demonstrated a high relapse rate among patients and sustained viral response rates of only 15%-25% (CDC, 1998).
Current treatment therapies have replaced alpha interferon with pegylated interferon (peginterferon), a more successful recombinant form of the original protein. Chemical modification of alpha interferon by the addition of polyethylene glycol has improved the uptake, distribution, and excretion of interferon, and increased active inhibition of HCV. Like alpha interferon, peginterferon must be injected subcutaneously. Chemical improvements, however, have reduced the treatment requirements from injections three times a week to only once a week for approximately 48 weeks. Studies have shown an overall increase in sustained viral response rates with peginterferon monotherapy to approximately 35% (NDDIC, 2006).
In 1998, hepatitis C treatment was further enhanced when the FDA approved the combination of interferon and ribavirin as treatment for patients with chronic hepatitis C (Herrine, 2002). Ribavirin is an antiviral agent that is usually taken orally two times a day. It has little effect on HCV by itself, but in combination with interferon, can lower relapse rates, increase sustained viral response rates to as high as 55%, and has been shown to rapidly lower ALT levels and eliminate detectable HCV RNA in up to 70% of patients (NDDIC, 2006). Combination therapy, as it is most often referred to, has become today’s standard form of hepatitis C treatment. Unless specific factors prevent the use of ribavirin, combination therapy will be applied over interferon monotherapy in all present cases (Ward and Kugelmas, 2005).
Despite the advances made over the past decade, problems continue to hinder the success of hepatitis C treatment. One of the biggest problems facing patients today is cost. On average, treatment costs approximately $20,000-$30,000 per year for the medication alone (Ward and Kugelmas, 2005). Although treatment is necessary for the management of hepatitis C in most cases, the expense of therapy often prevents individuals from pursing treatment. For those who receive treatment, medication poses the potential for side effects that can result in reduced medication dosages or an overall discontinuation of treatment. Common side effects of alpha and pegylated interferon include fatigue, muscle aches, headaches, depression, mild bone marrow suppression, and other related problems. Side effects range from mild to moderate in severity and usually diminish following the first few weeks of treatment. Common side effects of ribavirin, on the other hand, include anemia, fatigue, irritability, itching, birth defects, nasal stuffiness, sinusitis, and cough. Ribavirin is not advised for women who are pregnant or likely to become pregnant or for patients with blood related problems. Less than 2% of patients exhibit side effects uncharacteristic of interferon or ribavirin (NDDIC, 2006).
Because of the problems associated with hepatitis C therapy, treatment is not recommended for all patients. In fact, treatment is only highly recommended for chronic hepatitis C patients who have persistently elevated ALT levels, detectable HCV RNA, and a liver biopsy indicating severe inflammation or damage to the liver. These patients are considered to be at a greater risk for progression, and consequently, require treatment in order to survive. All other patients, including those with persistently normal ALT levels, advanced cirrhosis, alcohol or drug abuse problems, or contraindications such as depression, hyperthyroidism, life-threatening complications, or evidence of pregnancy, are not recommended for treatment and must receive medical clearance before beginning any such therapy (CDC, 1998).
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Epidemiology
In 2000, the United States Surgeon General declared hepatitis C a “silent epidemic.” With approximately 2% of the U.S. adult population infected, this appropriate declaration stems from the fact that hepatitis C is the most common chronic blood borne infection in the United States (Kim, 2002). Many of these infections will go undetected for years because victims display little to no symptoms during the early onset stages of the disease (CDC, 1998). Disease progression varies amongst individuals and depends on factors such as co-infection with other diseases, age, and alcohol/substance abuse patterns. Of those infected with the virus, up to 80% will develop chronic hepatitis and as much as 20% will progress into cirrhosis of the liver (Munoz-Plaza, et al., 2005).
Since the hepatitis C virus was only identified in the early 1990’s, accurate and reliable estimates of HCV infections and mortality rates in the United States are limited. Also, many patients with acute hepatitis are asymptomatic and, therefore, are never diagnosed. Additionally, some infected individuals may not have access to medical care, a factor which also contributes to the under-reporting of hepatitis C infection. These challenges make it very difficult to assess the true incidence of infection (Munoz-Plaza, et al., 2005).
As the identification and awareness of hepatitis C has led to an expanding movement of education, means of prevention, and enhanced testing efforts among injection drug users and blood donors, it is safe to predict that the incidence of HCV infection should begin to decline. In fact, the number of people with transfusionassociated HCV infection has already decreased significantly after the 1985 guidelines for selecting safer blood donors was implemented. Similarly, an effective system for screening blood for hepatitis C via HCV antibodies began in 1989, a step forward in the prevention of this epidemic. Moreover, the occurrence of safer needle-using practices among injection drug users has increased due to HIV and HCV awareness programs (Kim, 2002).
Unfortunately, the decrease in incidence of infection is not necessarily correlated with a decrease in the frequency of individuals infected with the virus. In fact, it is predicted that the prevalence of hepatitis C will increase over the years. This is due to the fact that many people who have already been infected are asymptomatic and have not yet been reported. There is often a significant lag time between the time of infection and the symptomatic manifestation of liver disease. In fact, some people will not develop symptoms for up to 20 years or more. As a result of this duration, the Center for Disease Control and Prevention predicts a four fold increase in the number of people reported to be chronically infected between 1990 and 2015 (Kim, 2002).
Similar to the underestimations of HCV infections, the mortality projections due to HCV are undoubtedly misrepresented. Most deaths caused from hepatitis C infection are due to liver failure and chronic liver disease. However, mortality statistics are based on the “underlying cause of death”. Therefore, in many cases, the U.S. system of death designation will list liver failure rather than hepatitis C as cause of death, even if the liver failure was caused by hepatitis C. In an attempt to estimate the number of deaths attributed to hepatitis C, the amount of in-hospital deaths from liver disease related to HCV was reviewed from the Healthcare Utilization Project database. In 1998, approximately 4,500 people died in hospitals in the U.S. from HCV-related liver disease (CDC, 2007).
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The largest range of recorded data was used in the third National Health and Nutrition Examination Survey (NHANES) to estimate the overall prevalence of HCV in the United States. In this survey, 21,000 non-institutionalized citizens were tested for HCV antibodies as well as viral HCV RNA in serum. Percentages from of this pool of data were collected and projected onto the United States population. According to the results of the NHANES, 3.9 million U.S. civilians were infected with HCV and 2.7 million of those infected suffered from chronic infection. Demographic disparities in the results indicated that infection was more prevalent in the age range of 30 to 49 years old: men were 20% more likely to be infected than women. The disease was most common in non-Hispanic blacks and least common in non-Hispanic whites. Only 1.5% of nonHispanic whites had HCV whereas 3.2% of non-Hispanic blacks had HCV (Kim, 2002).
Studies also suggest that individuals who suffer from severe mental illness are at a substantially higher risk for contracting blood-borne diseases such as HCV. For example, a particular study which focused on the occurrence of HCV among psychiatric patients had found that up to 19.6% of the 931 patients tested positive for HCV; this incidence rate is about 11 times higher than that of the rate of the normal adult population (Rosenberg, et al., 2001). This pattern of infection among psychiatric patients is most likely due to the high occurrence of drug use among the depressed and mentally ill populations.
Because syringe sharing and injection drug use is the major cause of HCV transmission and infection, the prevalence of HCV infection is extremely high among injection drug users. Several seroprevalence studies have shown that HCV infection occurs in up to 90% of injection drug users (Patrick, Buxton, Bigham & Mathias, 2000). When users were tested in some methadone maintenance treatment centers, as much as 96% were seropositive for HCV antibody while 62% were positive for HCV RNA (McCarthy & Flynn, 2001).
HCV in Correctional Facilities
About 85% of HCV infected inmates who were entering a Massachusetts prison reported a history of hepatitis, needle-sharing and previous drug use. Research studies have found that many inmates either begin or continue to engage in injection drug use during incarceration (Munoz-Plaza, et al., 2005). Since syringes tend to be more frequently used by many inmates in prison, the risk for sharing needles and needle syringe contamination is much higher than the outside world (Muller et al., 1995). As a result, HCV infection is relatively elevated among correctional populations.
Because injection drug users represent a dominant subpopulation in correctional facilities, a large percentage of HCV infected persons will inhabit or pass through prisons. According to surveys from the Bureau of Justice Statistics, the average length of a prison stay is approximately two-three years. One of the most recent in-depth studies was performed in 1997. It was deduced that between 29% and 43% of HCV infected people in the U.S. are released from a correctional facility in a given year (Hammett, Harmon & Rhodes, 2002). Since limited factual data is available on HCV infections, an indirect method was used to produce a rough estimate of HCV infection in prison populations. The logic of this study used the CDC’s estimate of 72% to 86% of injection drug users are infected with HCV. The estimate of 24% of prison inmates with history of injection drug use was multiplied by 72% and 86% to yield an approximation that 17% to
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21% of prison inmates are infected with HCV (Munoz-Plaza, et al., 2005). Furthermore, in 1997, a statistical analysis of this study produced an estimation of 1.3 to 1.9 million releases from prison had HCV; this implies that 29% to 43% of people with HCV infection have passed through a correctional facility in one year (Hammett, Harmon & Rhodes, 2002).
Despite the fact that such a large proportion of Americans with hepatitis C pass through a correctional facility, there is no national data on HCV incidence among inmates. Similarly, there is scarcely any data associating risk behaviors in prison with HCV contraction. This deficit in factual and statistical information contributes to the absence of a standardized system of health care and treatment programs in correctional settings. The collection of more data in prisons nationwide would allow for the better understanding of hepatitis C prevalence as well as the effectiveness of treatment; this would also help alleviate the controversies and challenges which have stood in the way of establishing national guidelines and recommendations for the management of this epidemic. Perhaps the establishment of a central database such as those used for cancer and HIV registries would enhance the progress of HCV intervention strategies (Allen, 2003).
Because of the growing frequency of HCV infections among incarcerated populations, the National Institute of Health (NIH) and the Center for Disease Control and Prevention have recognized the importance of improving HCV interventions in correctional facilities. Specifically, the 2002 NIH consensus statement supported a more aggressive approach to treatment compared with the 1997 statement (Hammett, 2003). It has seemed to become apparent to these organizations that the period of incarceration provides a window of opportunity to diagnose, evaluate and treat those at risk for severe health problems caused by hepatitis C. At the least, the development of a systemic screening program would identify those infected and those at risk in an attempt to reduce contraction during incarceration (Allen, 2003).
The prospect for the establishment of prevention, education and treatment programs in prisons does seem ideal considering that such a large percentage of people infected with HCV are in a confined setting. As a majority of inmates are only temporarily imprisoned and serve an average sentence of two to three years, healthcare addressing HCV would not only benefit the health of the inmates but the safety and health of the friends, families and communities to which the released prisoners return. Additionally, prison administrators and authorities are legally obligated to administer a satisfactory degree of healthcare, which treatment programs could potentially provide. A lack of interventions may leave prisons susceptible to lawsuits and criticism for neglecting the welfare of their inmates as well as the communities to which a majority of them are returned. For example, lawsuits have taken place in New Jersey when prisoners became aware of HCV programs in Pennsylvania prisons which dwarfed the comparable programs available in New Jersey facilities (Hammett, 2003).
As this issue remains a fairly new one, only a handful of prison systems have incorporated an HCV intervention program into their health management systems; among them are the Federal Bureau of Prisons, and facilities in Pennsylvania, Rhode Island, Wisconsin, Massachusetts and Indiana. (Hammett, 2003).
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Management Strategies for Correctional Settings
There are many components involved in the establishment of an efficient and productive HCV treatment system in correctional facilities. The level of staff involvement, medical resources, and funding allotted for the development of an HCV management program usually varies between state correctional systems. As a result, there exists a range of protocols and tactics implemented by different correctional facilities in addressing this prevalent disease. Nevertheless, HCV management systems in correctional facilities will employ comparable strategies as well as encounter similar challenges.
Prevention and Education
A major component involving the management and containment of this disease involves methods of prevention. Because there is no vaccine for HCV, preventative tactics must rely on education and risk-reduction practices. Health education can take the form of workshops, class presentations, videos, posters and brochures. Information dispersed covers risk factors for infection, methods of prevention such as clean needle use and routes of transmission. For example, a grassroots organization in Oregon conducts educational workshops for prisoners throughout the state (Munoz-Plaza, et al., 2005). Other prisons have utilized a peer education program in which professionals train inmates on how to provide counseling and education to fellow inmates. These peer educators have several advantages including the fact that they are much more accessible for private discussions than prison authorities and staff. Also, peers provide a more trustworthy, credible and comfortable source of consultation. Prisoners have admitted that they rarely listen to staff, but they will take advice from other inmates much more seriously. Furthermore, prisoners have reported that they fear appearing like a “snitch” if they are seen while engaged in a private discussion with a staff member (Munoz-Plaza, et al., 2005).
In an Australian journal article, other more extreme measures of prevention have been suggested to combat the HCV epidemic in the Australian prison system. One approach to limit HCV incidence is to provide methadone maintenance treatments for prisoners. Methadone substitution should help opiate-dependent injectors to decrease injecting usage. Another suggestion is for prison authorities to enforce lesser punishments for the use of non-injectable drugs compared with injectable drugs. This should encourage drug-dependent prisoners to try alternative drug methods which should decrease the usage of needle use amongst inmates (Dolan, 2001). Moreover, a third major strategy would be to make sterile injection resources more available, provide disinfectants to clean needles, and/or to implement sanitary needle/exchange programs. However, this remains to be a controversial topic as authorities do not want to condone drug usage (Vlahov, Astemborski, Solomon & Nelson, 1994). It is also believed that transmission of HCV in prisons is due to unsanitary tattooing practices. An approach to limit HCV infection would be to properly train selected inmates on the sterile and proper techniques of tattooing as well as provide autoclaves and single-use ampoules of ink (Dolan, 2001).
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Screening
Aside from the educational and preventative measures taken by some correctional facilities, a major initial step in an HCV management program is screening individuals for infection. Recent guidelines from the Center for Disease Control indicate that all inmates should be questioned for risk factors regarding HCV infection during their entry medical evaluation. Those inmates who affirm to any of those risk factors should be tested for HCV.
Both universal and targeted screening approaches have been practiced in different prison systems. In Indiana, mandatory testing for HCV and HIV has been enforced. The Indiana Department of Health oversees the testing procedures in which each inmate must donate blood samples. The system in Wisconsin practices a targeted screening approach in which select individuals require testing if their answers to risk-based assessments imply risk. Some of the many risks listed in the survey included a history of needle sharing, being a recipient of blood clotting factor before 1987, being on long-term hemodialysis, having been infected with hepatitis B, and having evidence of liver disease (Allen, 2003).
Although a systematic approach for antiviral treatment is available, the HCV management system in Rhode Island correctional facilities has a weakness in its screening methods. They lack any form of routine screening despite the high percentage (~26%) of inmates who are infected at any given time. As screening is not mandatory or routine, inmates in Rhode Island must individually request to be tested (Hammett, 2003).
Mental Illness and Substance Abuse
The correctional population has a high percentage of inmates with psychiatric illness and/or histories of substance abuse. These two groups used to be excluded from any type of HCV treatment. However, several findings have allowed the NIH consensus statement in 2002 to lift the standard contraindication for therapy for those with substance abuse problems. Experts believe that a correctional setting can be an ideal place for treatment since sobriety is heavily enforced. As long as substance abuse counseling is readily available and inmates are monitored closely while on treatment, substance abuse is no longer an accepted contraindication for HCV treatment. Similarly, having psychiatric illness will no longer exclude a prisoner from treatment. Because interferon will chemically lower the body’s amount of tryptophan, which is a precursor of serotonin, it was originally believed that treating a mentally ill patient with interferon would dangerously exacerbate his/her psychiatric state. Currently, several studies have shown no evidence supporting the assumption that treatment will cause more severe depression in those already afflicted with mental health disorders. In addition, the close clinical monitoring which can be provided in prison may provide a safer clinical setting for treatment for mentally ill inmates. However, the eligibility criteria for receiving treatment will ultimately be decided by each correctional setting (Allen, 2003).
Challenges
Healthcare administrations for correctional facilities are concerned that the high occurrence of HCV infection among incarcerated populations combined with the steep cost of HCV treatment will overwhelm already constricted healthcare budgets. Hence, the
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cost of a treatment program for HCV is most likely the largest challenge facing the establishment of diagnosis and treatment programs.
However, the development of efficient systemic approaches to testing and evaluation for treatment will drastically reduce the number of inmates eligible for treatment. As previously stated, only those with advanced infection and liver disease will receive treatment. Furthermore, inmates will be excluded from treatment if their period of incarceration is not long enough to cover the full course of treatment.
Specifically, in Rhode Island correctional systems, only a very small fraction of HCV-infected inmates received treatment. Between 1997 and 2000, 349 tested positive for HCV infection. Of this number, ninety were eligible for treatment. In order to become eligible for treatment, inmates were required to meet a list of criteria. Among the requirements, inmates had to have at least fifteen months left to serve. This would ensure that enough time was available for treatment and follow-up. In addition to this, patients had to be psychiatrically cleared on a case by case basis and those who had a history of substance abuse had to either enter a substance abuse treatment or had to have been sober for at least one year. Of the inmates eligible for treatment, forty-one of them completed the full course of treatment while the remaining forty-nine were assumed to have completed half the course. At the time, the cost of one course of antiviral treatment was about $9,500; thus, the estimated total cost was $622,250. This represented about 5% of the total health care budget of the Rhode Island Department of Corrections. Overall, this expense was not overburdening to Rhode Island's healthcare budget (Hammett, 2003). Also, an advantage of antiviral treatment for HCV is that unlike treatment for HIV which involves ongoing medical attention, it is only given for one course and then it is completed, thus
Besides cost, other factors will challenge the feasibility of the integration of HCV prevention, diagnosis and management programs in correctional facilities. Some constraints include a limited working staff as well as other healthcare priorities which may compete with HCV care. Also, a devoted cooperation and communication between correctional health and public/private health-care practices needs to be established. Moreover, incarcerated populations are relatively disliked and ostracized by the general public. The combined lack of political power and influence makes it easy for government officials to overlook their needs (Hammett, Harmon & Rhodes, 2002).
The Current Evaluation and Management Practices for the Treatment of Hepatitis C in Massachusetts Correctional Facilities
The process by which Massachusetts inmates are screened and evaluated for HCV treatment involves a methodical and thorough series of steps. To start with, instructive resources such as peer education and counseling on preventative measures are available to all inmates, regardless of their HCV status. Information offered covers the symptoms of HCV, ways the disease can be contracted, treatment options, and the side effects associated with treatment. Additionally, infected inmates are informed of behaviors which could exacerbate their condition, such as alcoholic intake which will augment liver damage.
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Screening for Treatment Eligibility
During their entry medical evaluation, an individual’s likelihood of HCV infection is assessed through the inmates’ history of several risk factors. If the individual has a history of intravenous drug use, has received a blood transfusion before July of 1992, has had multiple sexual partners and/or has had a sexual partner with HCV, then he/she is deemed at high risk for having contracted the disease. Only one affirmation to these experiences is needed to qualify for an HCV antibody test. If the individual tests positive for HCV antibodies, then liver function tests are checked periodically. During this time, hepatitis A and hepatitis B statuses are checked and the individual is immunized for hepatitis A and hepatitis B, if possible (Brewer, Marshall, Demaria, 2007).
After one year has passed since the HCV antibodies were detected, the HCV RNA viral load is measured. If the individual tests positive for HCV RNA, then he/she undergoes a series of both medical and laboratory evaluations to determine his/her eligibility for a liver biopsy. The medical evaluation ensures that the inmate has no history of renal transplantation, decompensated cirrhosis, severe depression, major medical illnesses such as diabetes or chronic obstructive pulmonary disease (COPD), intravenous drug use or alcohol use within the past twelve months, or disciplinary reports within the past year involving substance abuse. In addition, individuals should show no evidence of any autoimmune disease and, if female, should not be pregnant. Failure to meet these criteria will most likely exclude an HCV infected individual from continuing with the treatment evaluation process.
The laboratory segment of the evaluation process consists of white blood count, serum creatine, platelet, bilirubin, albumin and prothrombin level measurements. In most cases, abnormal levels for these labs will prevent an individual from proceeding onto a liver biopsy. However, abnormal lab values are not an absolute contraindication for continuing with the treatment qualification process. An antibody test for HIV is also implemented to determine if the patient should be referred to the HIV/HCV co-infection clinic.
Upon satisfying the criteria for both the medical and laboratory assessments, the HCV infected person will undergo a liver biopsy. Liver biopsies provide the physician with evidence on whether or not moderate inflammation and/or fibrosis of the liver are occurring. Treatment is not recommended if the liver biopsy is fairly normal, but it is recommended when the health status of the liver is compromised.
Pre-treatment Protocol
Once HCV treatment is recommended, the Hepatitis C worksheet (Appendix A) must be filled out and sent to the Hepatitis C Program Manager in the UMass Correctional Health Program of UMass Medical School. The Hepatitis C Program Manager oversees the treatment waiting list for all HCV infected inmates in the seventeen Massachusetts correctional facilities. As of February 2007, there were sixty-eight inmates on therapy and twenty on the waitlist. The maximum number of inmates allowed on HCV therapy at one time is ninety-five. It is part of the manager’s responsibility to update records as well as keep track of who is currently on therapy and which individuals are next on the waitlist. Inmates who have been approved to receive treatment but are on the waitlist are divided into 4 categories:
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Case 1:15-cv-12298-NMG Document 35-4 Filed 05/16/16 Page 18 of 67
1. Treatment naïve a. Genotype 1, 2, 3 and 4
2. Dual Diagnosis (HCV/ HIV) a. Fulminant (go to top of list) b. Non-Fulminant
3. Relapsers, Treatment Failures and Non-Responders after Interferon/Ribavirin Combination Therapy
4. Date of biopsy and length of time since biopsy will be considered
The selection of patients to be treated occurs in increments of ten. Five individuals from category one, two to three from category two, and two to three patients from category three are chosen. Patients classified under the “Fulminant Dual Diagnosis” category are given top priority for treatment. They are the most critically sick, and as a result, are moved to the top of the list regardless of the date they were diagnosed. Additional factors which place a higher urgency to treat include the severity of the liver biopsy as well as the length of time a patient has been waiting on the treatment waitlist. Each patient in a group of ten will receive treatment before an additional group of ten inmates is to be selected (Brewer, Marshall, Demaria, 2007).
Prior to initiating HCV therapy, several parameters must be addressed. First of all, it must be verified that the patient will be incarcerated for greater than one year after treatment begins. A short sentence prevents patients from receiving a complete course of treatment as well as follow-up testing to monitor their HCV status and evaluate treatment effectiveness. Secondly, a full history and physical examination must be conducted and recorded on the Hepatitis C worksheet (Appendix A). Patients with certain other health conditions must undergo additional testing before they can be cleared for therapy. For example, patients with a history of coronary artery disease are required to have an EKG and possibly a stress test, while patients with diabetes should be tested for fasting glucose and hemoglobin levels.
The next step requires the patient to read, understand and sign the “Inmate Agreement” form (Appendix B). This sheet represents the patient’s consent to begin treatment. By signing this form, the patient acknowledges his/her understanding of the disease process, its effects on their health, treatment options, side effects of treatment and the varying levels of success experienced by different HCV infected patients on treatment. The patients must acknowledge all of the health risks associated with therapy and must inform the medical staff of any symptoms. They must also pledge to avoid illegal drug and alcohol use, and tattoos. Infringing upon these rules will result in termination of treatment.
Another step before initiating therapy is the measurement of several baseline lab values, the most important being the HCV RNA viral load just prior to treatment. Others include ALT, white blood cell, hemoglobin, hematocrit, platelets, cholesterol, triglycerides, glucose, albumin and thyroid stimulating hormone (TSH) levels. Woman must take a pregnancy test to verify they are not pregnant while on treatment. Once treatment is initiated, patients are closely monitored by the medical staff to ensure they are comfortable on therapy and remain symptom free. As previously mentioned, common side effects of pegylated interferon and ribavirin are flu-like symptoms, nausea, abdominal discomfort, loss of appetite, edema, rash, reactions at injection site, muscle
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Case 1:15-cv-12298-NMG Document 35-4 Filed 05/16/16 Page 19 of 67
aches, loss of hair and symptoms associated with depression (Brewer, Marshall, Demaria, 2007).
The Process of HCV Therapy
The most commonly used medications for the treatment of HCV are pegylated interferon and ribavirin. This combination therapy is recommended for all patients except for those with special circumstances, such as patients who are co-infected with HIV and HCV. After twelve weeks of HCV therapy, the HCV RNA viral load is tested. Only if there is at least a two log reduction of the HCV RNA viral load will the treatment be continued. If there is less than a two log reduction, the patient is considered unresponsive to treatment. In this case, the medication is discontinued and the patient is then closely monitored in chronic care. A full course of HCV therapy for genotypes 2 and 3 is twenty-four weeks while for other genotypes it is forty-eight weeks. The HCV-RNA viral load is again measured at the completion of treatment as well as six months after therapy ends to assess for a sustained anti-viral response.
In addition to HCV RNA viral loads, complete blood counts are drawn throughout the course of treatment to examine the effects of the medications on hemoglobin, white blood count, neutrophils, platelets, hematocrit, ALT, TSH, and viral load levels. If hemoglobin levels drop, the dosage of ribavirin is decreased. If the white blood cell count, absolute neutrophils and platelets drop, then pegylated interferon is decreased. Besides blood tests, females must also take a pregnancy test every month during therapy (Brewer, Marshall, Demaria, 2007).
The overall evaluation process for the management and treatment of hepatitis C infected inmates in Massachusetts facilities are summarized in the flow charts found on the following pages.
Inmates Co-infected with HIV and HCV
In order to be referred to the HIV/HCV co-infection clinic, the patient must have tested positive for HIV antibodies or detectable HIV RNA as well as have a positive HCV antibody test or evidence of HCV RNA. Similar to mono-infected inmates, liver function tests along with baseline labs should be drawn including complete blood counts, CD4 counts and percentages, albumin, prothrombin, and HIV RNA levels. Evaluation by the gastroenterologist and the infectious disease specialist will determine whether or not a liver biopsy will be conducted. An additional right upper quadrant ultrasound is to be done before the biopsy. If chronic HCV infection along with HIV viremia is present, Pegasys plus/minus ribavirin will be recommended as therapy if no other contraindications exist. A closer follow-up is necessary with co-infected patients in order to monitor for the expected side effects as well as the potential for other severe symptoms to occur. For some co-infected patients on treatment, antiretroviral therapy has had to be terminated due to hepatotoxicity. Other patients must have frequent endoscopies if their cirrhosis worsens in order to verify whether or not they have esophageal varices (Brewer, Marshall, Demaria, 2007).
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Case 1:15-cv-12298-NMG Document 35-4 Filed 05/16/16 Page 20 of 67
Peer education and counseling for all inmates. Entry examination; assessment of risk behaviors

If inmate is at high risk of HCV infection, then they must take an HCV antibody test.

If negative HCV antibody test; then counseled on HCV prevention

If tested for positive HCV antibody; - observed for 1 year - periodic liver function tests - immunized to Hep A & Hep B

After 1 year, check HIV RNA viral load
14

Non-Detectable HCV RNA; counseled on prevention

Case 1:15-cv-12298-NMG Document 35-4 Filed 05/16/16 Page 21 of 67
If presence of HCV RNA is detected, then patient must undergo a medical and laboratory evaluation. Only if patient meets the inclusion criteria for both the medical and laboratory evaluations can they be referred for a liver biopsy.

Medical consultation to perform liver biopsy. Physician evaluates liver biopsy for signs of inflammation/ fibrosis

HCV treatment not recommended

HCV treatment recommended Prior to treatment - Review/sign Inmate Agreement form - Full History & Physical Exam; information transferred to Hep C Worksheet and sent to Hepatitis C Program Manager

Placed on waitlist - make sure incarceration period is at least 1 year at start of treatment - must be sober for at least 1 year before treatment begins
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Case 1:15-cv-12298-NMG Document 35-4 Filed 05/16/16 Page 22 of 67
Begin HCV Therapy -Must have baseline labs measured prior to treatment initiation (HCV RNA is most important) -Certain labs are measured throughout course of treatment according to treatment lab protocol

HCV RNA viral load measured at 12 weeks into treatment

Less than a 2 log reduction of HCV viral load; Discontinue therapy

2 log or greater reduction of HCV RNA viral load; Continue treatment

Continue follow-up of patient in chronic care

HCV RNA viral load measured at completion of full course of therapy (24 or 48 weeks)
Measure HCV RNA viral load 6 months post therapy to check for sustained response
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Case 1:15-cv-12298-NMG Document 35-4 Filed 05/16/16 Page 23 of 67
The HCV Database
The prospect of establishing hepatitis C management programs in correctional facilities does seem ideal considering that such a large percentage of people infected with HCV are in a confined setting. It has become apparent to several states that the period of incarceration provides a window of opportunity to screen, evaluate and treat those at risk for hepatitis C. Among the states which have implemented a hepatitis C treatment program in correctional facilities is Massachusetts. In 2004, a database was created to monitor and assess the treatment of hepatitis C infected individuals in Massachusetts correctional facilities. As of March 2005, 262 inmates treated were entered into this database. An analysis conducted for this data set revealed that the majority of inmates treated were Caucasian, male and infected with HCV genotype 1. The database also provided information regarding treatment response and success rates; almost half of the inmates treated had achieved a successful response, reaching an undetectable HCV viral load (Kelly, 2005).
The purpose of this project was to update the database with additional inmates who were treated up until February 2007. After the medical and treatment information from the forms of these inmates were transferred into the database, a demographic analysis was performed such that the characteristics (gender, race, age, facility) of inmates treated could be summarized. A demographic synopsis provided a review of who is treated with the benefit of minimizing any intentional or unintentional bias. Predispositions of the facilities to treat certain populations over others can be exposed through this analysis, providing the management incentive to review protocols.
Response to treatment was similarly assessed based on lab results entered in the database. HCV RNA viral loads and ALT levels proved to be important indicators of treatment success. Consequently, HCV RNA levels were used to examine any correlations between the success of treatment and viral genotype as well as HIV coinfection. Results have shown that inmates with genotype 1 have the least successful responses when compared with genotypes 2, 3 and 4. In addition, co-infection with HIV was found to drastically reduce the chance of successful treatment outcomes.
Other major components looked at in the database were reasons for treatment interruptions and causes of premature termination of treatment. Among others, these included severe and intolerable side effects, poor anti-virological response to the medications, and early release from prison. Although an inadequate amount of data was available to perform a quantitative analysis, a qualitative evaluation of the reasons for unsuccessful and incomplete courses of treatment may serve as a reference for improving upon the efficiency of the screening and treatment protocols. Several recommendations for improvements in the database included the collection of missing data and the development of a stricter follow-up system. Variables such as inmates' history of substance abuse and the presence of mental and physical health conditions were missing data for nearly half the inmates. Follow-up HCV RNA measurements were similarly missing for an even larger percentage of inmates. This information is vital in determining the success rate of treatment.
The value of the hepatitis C treatment database for HCV infected inmates in Massachusetts correctional facilities is in its contributions to the limited knowledge of this disease and its management. Despite the large proportion of HCV infected people who pass through a correctional facility, there is still a shortage of factual and statistical
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Case 1:15-cv-12298-NMG Document 35-4 Filed 05/16/16 Page 24 of 67 information on HCV infection among inmates. Not having a database for tracking HCV incidence and treatment contributes to the absence of a standardized system of health care and treatment programs in correctional settings. The collection of more data in correctional facilities would allow for the better understanding of hepatitis C prevalence as well as the effectiveness of its treatment. Ideally, more facilities will follow in the footsteps of the Massachusetts treatment program and employ an efficient system of data collection and organization.
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Materials and Methods
This project was conducted over a six month period, from November 2006 to April 2007. During this time, research was approved, data was collected, and the SPSS database was revised and updated. An analysis of the data was used to assess the effects of changes made to the original data collection process as well as examine the current state of hepatitis C treatment in Massachusetts state correctional facilities.
Research Preparation
Preparation for data collection and handling began as early as November 2006. Prior to the start of any clinical research project, an intensive review must be conducted by the Institutional Review Board (IRB). The IRB is a review committee typically composed of five members of various sexes, backgrounds, and professions. It was originally created in the 1970’s to help protect the rights and welfare of human research subjects by ensuring that clinical studies are well designed, ethical, legal, and safe. IRBs have the authority to modify, approve, or disapprove any research study involving human subjects after an extensive review of the proposed course of action. Most research institutions, professional organizations, and scholarly journals have established IRBs (Epley, Erickson, and Selwitz, 2006; National Cancer Institute [NCI], n.d.).
For this particular project, data collection could not begin until an IRB training course had been completed by each individual researcher. The Collaborative IRB Training Initiative (CITI) is an online course in the protection of human research subjects that is required by the University of Massachusetts, Worcester. It is comprised of various training modules regarding the history of the IRB, the function of the IRB, and the conduction of research involving different human populations including vulnerable subjects such as prisoners. Completion of the course required a review of each module as well as a corresponding quiz. Individual certificates of completion were received at the conclusion of the course and sent for approval by the IRB at the University of Massachusetts, Worcester as well as the Massachusetts Department of Correctional Facilities. Complete IRB approval was achieved by December 2006.
Data Collection
Data was collected for this project over a two month period, from January 1, 2007 to March 1, 2007. Demographic, health, and treatment-related information was gathered on a total of 177 inmates including 109 inmates now off treatment and sixty-eight inmates currently on treatment. Data for each inmate was extracted directly from individual hepatitis C worksheets (Appendix A) completed and stored in the medical records file of each individual.
The current hepatitis C worksheet is a one-page record of inmate history and treatment. It contains basic information such as name, age, race, weight, and height; a brief medical history including current health or mental health conditions, a history of alcohol or drug abuse, and a history of co-infection; as well as treatment-related data such as treatment start and end date, lab figures, changes in treatment, and any necessary notes. Originally, the hepatitis C worksheet was a two-page treatment record updated regularly by nurses and doctors (Appendix C). However, when data collection began in 2004, information from these original worksheets was extracted and transferred to a more
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organized data collection worksheet (Appendix D). Although this worksheet included all the information necessary to monitor the progress of the inmates and the types of inmates being treated, the extensive length of the paperwork resulted in an increasing amount of missing data. On September 27, 2004, a new one-page hepatitis C worksheet was created and later revised to the current worksheet in 2005 (Appendix A). This treatment record is typically filled out prior to the start of treatment by HIV/Hepatitis C case managers at each health service unit. Following the start of treatment, sheets are transferred and information is continually updated by the Hepatitis C Program Manager for UMass Medical School and the UMass Correctional Health Program.
In order to maintain the confidentiality of inmates during the data collection process, names were blacked out and inmates were coded with an arbitrary five digit number beginning with 55 or 88. A 55 number indicated inmates with data from the old hepatitis C worksheets, while an 88 number indicated inmates with data from the new hepatitis C worksheets. All data input over the course of this project was extracted from the new worksheets. This included updated information for inmates that had already completed or discontinued treatment in the past three years, old data from 2004 and 2005, and new data for inmates that had recently started treatment.
Differences were noted in the amount of information each worksheet contained. Worksheets completed within the past year were nearly, if not entirely, complete. Older, worksheets, however, were frequently missing large amounts of important information such as height, weight, incarceration date, current health conditions, history of alcohol or drug abuse, and reasons for any discontinuation of or interruptions in treatment. It was unclear as to whether or not this data was actually missing, unknown, or not applicable. In either case, all data considered missing was compiled into various “missing data logs” and sent to the program manager who had direct contact with inmates and case managers and could potentially retrieve necessary data.
Data Entry
All information collected during the course of this project was input into an SPSS database. SPSS for Windows is an analytical software program devised by SPSS Inc. for data collection, data access, data management and preparation, statistical data analysis, and reporting (SPSS Inc., 2007). Actual data entry was conducted in a large SPSS spreadsheet. Different rows indicated different inmates whereas different columns indicated different fields of data associated with the hepatitis C worksheet. Assigned row numbers and specific column headers were used to differentiate inmates and identify data requirements, respectively. Inmates were numerically ordered in the database according to their assigned five digit code beginning with 55 or 88. All data was entered into the appropriate rows and columns based on specific variables previously coded into the SPSS system. Number as well as word variables were used to define available and unknown data. Missing information was indicated in the database by blank fields.
Data Analysis
Between March 2007 and April 2007, a statistical analysis of the complete data set was conducted using the SPSS program. The analysis was focused primarily on characterizing the types of inmates being treated, summarizing the overall progress of hepatitis C treatment, and identifying potential trends or correlations between inmate
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characteristics and the success of treatment. Only those fields of data which had limited amounts of missing information in the database were assessed.
To account for the changes that have taken place in hepatitis C treatment since 1999, data was analyzed based on one of two different categories: inmates who have received treatment since 1999 and inmates who have received treatment since August 2002. February 1999 marked the start of hepatitis C treatment for inmates in the database, whereas August 2002 marked the start of combination therapy as the standard form of treatment in Massachusetts state correctional facilities. Creation of the two categories allowed for a more accurate assessment of the types of inmates being treated and the current progress of treatment.
For inmates who had received treatment since 1999, data analyses were conducted to summarize the trends in inmate characteristics and treatment center operations that were unaltered by the 2002 changes in hepatitis C treatment. In particular, data was used to assess inmate demographics such as gender, age, and race, the frequency of genotypes among inmates, and the frequency of treatment at each treatment center. Assessments of additional information such as health conditions, mental health conditions, and prior history of substance or alcohol abuse were not made due to the large percentage of missing data in these fields.
Although the 2002 changes in standard treatment did not affect the types of inmates who had received treatment since 1999, they could have affected the overall outcome and progress of treatment. In order to accurately assess these effects, treatment related data was only analyzed for those inmates who had received treatment since August 2002. Data was used specifically to assess variations in ALT and HCV RNA levels prior to the start of treatment, the frequency of undetectable viral loads attained by the end of treatment, the frequency of genotypes among inmates and their potential correlation with treatment outcome, the frequency of HIV co-infection among inmates and its potential correlation with treatment outcome, the frequency of treatment interruption, and the frequency of treatment discontinuation as well as the reasons given for stopping treatment. Any additional assessments were deemed unnecessary or could not be made due to missing data constraints.
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Results
To account for the division in statistical analyses, results have been classified under two different categories: inmate characteristics and response to treatment. Each category is based on a specific set of inmates whose data was used to assess a number of different fields. The results for each analyzed field have been individually summarized within their corresponding category and are based on statistical data tables originally output by SPSS. Summaries are characterized by verbal highlights, graphs, and tables similar to those generated by SPSS.
All results have been organized by SPSS in terms of valid and missing data. Valid is an expression used to define all known and legitimate data that has been input into the database. Missing, on the other hand, is an expression used to define all data that is either missing from the database, has been input into the database as unknown, or has been incorrectly input into the database as an undefined variable. Undefined variables and unknown data are specifically referred to as unknown, whereas data missing from the system is referred to by the term system.
Results from the actual SPSS analysis of valid and missing data are presented in three different forms: frequency, percent, and valid percent. “Frequency” refers to the actual number of inmates that fall within a given category. This result represents the total number of inmates analyzed within a given field, and thus includes all valid and missing data. “Percent” is the calculated percentage of inmates within a given category based on the total number of inmates analyzed. This, again, represents the total number of inmates analyzed and includes both valid and missing data. “Valid Percent” is the only result that does not include missing data. It is the calculated percentage of inmates within a given category based solely on the total number of inmates with valid data.
Due to the extent of missing data in the database, the total number of inmates with valid data was not equivalent to the number of inmates analyzed within each field. However, these figures were the most accurate representation of the data within the database. Consequently, valid frequencies and valid percents were used to summarize the results of each field.
Inmate Characteristics
The following results are based on all inmates who have received treatment since 1999. This year marked the start of hepatitis C therapy for inmates included in the database. As of March 1, 2007, data on a total of 510 treated inmates has been collected and input into the HCV database. This data was used to assess the overall characteristics of inmates receiving treatment including the facility at which they first began treatment as well as their gender, age, race, and HCV genotype.
Facility at Start of Treatment
Out of 510 inmates treated, 479 (93.9%) inmates had a documented name for the correctional facility at which their treatment was initiated. A total of 17 correctional facilities were identified as having provided hepatitis C treatment since 1999. The number of inmates treated varied among the facilities, ranging from as low as 2 inmates to as high as 78 inmates. The majority were treated at Massachusetts Correctional Institution - Norfolk (78), Souza-Baranowski Correctional Center (71), and Massachusetts Correctional Institution – Shirley (66). A limited number of inmates
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received treatment at the Massachusetts Alcohol and Substance Abuse Center (2), Old Colony Correctional Center Min (3), Bridgewater State Hospital (4), and Massachusetts Correctional Institution - Plymouth (4). Results for all 17 correctional facilities have been summarized in Table 1. A bar graph of the number of inmates treated at each facility at the start of treatment is shown in Figure 1.

Table 1: Frequency and Percentage of Inmates among Massachusetts State Correctional Facilities at the Start of Treatment

Valid
Missing Total

Facility
Baystate Bridgewater Concord Concord Farm Framingham Gardner MASAC Norfolk OCCC OCCC Min Pondville Plymouth Shirley Medium South Middlesex Souza Baranowski Treatment Center Walpole Total Unknown System Total

Number of Inmates
27 4
16 14 15 49
2 78 54
3 5 4 66 6 71 13 52 479 6 25 31 510

Percent

Valid Percent

5.3

5.6

0.8

0.8

3.1

3.3

2.7

2.9

2.9

3.1

9.6

10.2

0.4

0.4

15.3

16.3

10.6

11.3

0.6

0.6

1

1

0.8

0.8

12.9

13.8

1.2

1.3

13.9

14.8

2.5

2.7

10.2

10.9

93.9

100

1.2

4.9

6.1

100

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Case 1:15-cv-12298-NMG Document 35-4 Filed 05/16/16 Page 30 of 67

Number of Inmates Treated

Figure 1: Distribution of Inmates among Massachusetts State Correctional Facilities at the Start of Treatment
90

80

70

60

50

40

30

20

10

0 BaystaBteridgewater ConcCoordncord FarFmramingham Gardner MASAC Norfolk

OCCCOCCC

in M

Pondville

PlymSohuirtlhey

MSedoiuutmh MiSdodulezsaeBxaranTorweastkmient

Center

alpole W

Facility

Gender
Out of 510 inmates treated, 484 (94.9%) inmates had a documented gender. 467 (96.5%) of those inmates were male, whereas only 17 (3.5%) of those inmates were female. All 17 female inmates received hepatitis C treatment at either the Massachusetts Alcohol and Substance Abuse Center (MASAC) or Massachusetts Correctional Institution – Framingham (MCI – Framingham). Statistical results for the frequency of male and female inmates treated have been summarized in Table 2 and graphed in Figure 2.
Table 2: Frequency and Percentage of Male and Female Inmates Treated

Valid Missing Total

Gender
Male Female Total Unknown System Total

Number of Inmates
467 17 484 1 25 26
510

Percent

Valid Percent

91.6

96.5

3.3

3.5

94.9

100

0.2

4.9

5.1

100

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Case 1:15-cv-12298-NMG Document 35-4 Filed 05/16/16 Page 31 of 67

Number of Inmates Treated

Figure 2: Distribution of Male and Female Inmates Treated

500

450

400

350

300

250

200

150

100

50

0 Male

Female

Gender

Race
The race/ethnicity of those treated for HCV in Massachusetts Correctional facilities was recorded for 356 (69.8%) of the inmates in the database. According to the known data, Caucasians were the most frequently treated race with 224 (62.9%) inmates. Hispanic/Latino and African Americans were nearly tied for the second highest race/ethnicity treated for HCV in MA facilities. There were 66 (18.5%) Hispanic/Latino inmates treated while there were 63 (17.7%) African Americans treated. One (0.3%) Native American and two (0.6%) inmates classified under “other ethnicity” were treated. Table 3 contains all of the frequencies and percentages of the inmates’ ethnicities and Figure 3 displays the valid percentages of the inmates’ race/ethnicities.

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Table 3: Frequency and Percentage of Race/Ethnicity among Inmates Treated

Race/Ethnicity

Valid
Missing Total

Caucasian
Black/African American Hispanic/ Latino Native American Other Total Unknown System Total

Number of Inmates
224
63
66 1 2
356 87 67 154 510

Percent

Valid Percent

43.9

62.9

12.4

17.7

12.9

18.5

0.2

0.3

0.4

0.6

69.8

100

17.1

13.1

30.2

100

Figure 3: Race/Ethnicity of Inmates Treated

Native American 0.3%
Hispanic/Latino 18.5%

Other 0.6%

Black/ African American 17.7%

Caucasion 62.9%

Age
A majority of the information regarding the ages of the inmates at the start of HCV therapy was entered into the database; out of the 510 inmates, 475 (93.1%) had a recorded age. The ages of those inmates who started treatment ranged from as young as 22 to as high as 71 years old. The majority of those individuals on HCV therapy began treatment when their age fell within the range of middle thirties to late forties. The two ages which had the highest number of inmates treated (28 patients), were 42 and 45 years old. The average age of inmates beginning treatment was 42.9 while the median was 43 years old. See Table 4 for the complete age data set. Figure 4 shows the number of inmates who started therapy at each specific age.
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Valid
Missing Total

Table 4: Age of Inmates at the Start of Treatment

Age
22 24 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 64 68 69 71 Total Unknown System Total

Number of Inmates
1 2 5 7 5 9 8 10 14 5 8 8 18 12 20 26 26 23 28 20 20 28 18 20 21 20 11 10 14 9 5 10 9 5 3 7 6 1 1 1 1 475 8 27 35
510

Percent

Valid Percent

0.2

0.2

0.4

0.4

1

1.1

1.4

1.5

1

1.1

1.8

1.9

1.6

1.7

2

2.1

2.7

2.9

1

1.1

1.6

1.7

1.6

1.7

3.5

3.8

2.4

2.5

3.9

4.2

5.1

5.5

5.1

5.5

4.5

4.8

5.5

5.9

3.9

4.2

3.9

4.2

5.5

5.9

3.5

3.8

3.9

4.2

4.1

4.4

3.9

4.2

2.2

2.3

2

2.1

2.7

2.9

1.8

1.9

1

1.1

2

2.1

1.8

1.9

1

1.1

0.6

0.6

1.4

1.5

1.2

1.3

0.2

0.2

0.2

0.2

0.2

0.2

0.2

0.2

93.1

100

1.6

5.3

6.9

100

27

Case 1:15-cv-12298-NMG Document 35-4 Filed 05/16/16 Page 34 of 67

Figure 4: Age Distribution at Start of Treatment
30

25

Number of Inmates

20

15

10

5

0
22 24 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 64 68 69 71
Age at Start of Treatment

HCV Genotype
A summary of viral genotype groups was conducted from the 440 (86.3%) inmates who had a recorded HCV genotype in the database. With a frequency of 291 (66.1%), the majority of inmates were infected with HCV genotype 1. 78 (17.7%) inmates were infected with genotype 3 while 51 (11.6%) inmates were infected with genotype 2. Only 20 (4.5%) inmates had genotype 4. Table 5 lists the frequencies and percentages of the HCV genotypes. Figure 5 displays the distribution of HCV genotype groups among infected inmates who began treatment.

Table 5: Frequency and Percentage of HCV Genotypes among Inmates Treated

HCV Genotype

Valid
Missing Total

Genotype 1 Genotype 2 Genotype 3 Genotype 4 Total Unknown System Total

Number of Inmates
291 51 78 20 440 39 31 70 510

Percent

Valid Percent

57.1

66.1

10

11.6

15.3

17.7

3.9

4.5

86.3

100

7.7

6.1

13.7

100

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Figure 5: Distribution of HCV Genotypes among Inmates Treated

Genotype 3 17.7%

Genotype 4 4.5%

Genotype 2 11.6%

Genotype 1 66.1%

Response to Treatment
The following results are based on all inmates who have received treatment since August 2002. This date marked the start of combination therapy (interferon + ribavirin) as the standard form of treatment in Massachusetts state correctional facilities. As of March 1, 2007, a total of 370 inmates have been documented in the database as having received treatment since August 2002. Data from these inmates was used to assess the overall response of inmates to treatment including variations in ALT and HCV RNA levels prior to the start of treatment, the frequency of undetectable viral loads attained by the end of treatment, the frequency of genotypes among patients and their potential correlation with treatment outcome, the frequency of HIV co-infection among patients and its potential correlation with treatment outcome, the frequency of treatment interruption, and the frequency of treatment discontinuation as well as the reasons given for stopping treatment.
Baseline ALT Levels
Out of 370 inmates treated, 302 (81.6%) inmates had a documented baseline value for the level of alanine aminotransferase (ALT) in the blood. These values were measured in terms of International Units per Liter (IU/L). Typically, in a normal and healthy individual, ALT levels in the blood tend to range between 0 and 40 IU/L (Franciscus and Teeter, 2006). According to the labs of inmates treated, baseline ALT levels ranged from 12 IU/L to 627 IU/L. The average ALT level was calculated around 90.26 IU/L, whereas the median ALT level was approximately 68 IU/L. The majority of inmates (60.5%) had baseline ALT levels between 30 IU/L and 79 IU/L. Due to the large
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percentage of missing data, ALT levels at 12 weeks and 24 weeks into treatment could not be assessed. Refer to Table 6 for all relative data figures and percentages and Figure 6 for a bar graph of the number of inmates and their associated baseline ALT levels.

Table 6: Baseline ALT Levels among Inmates Treated

Baseline ALT Level

Valid
Missing Total

< 20 20 – 29 30 - 39 40 - 49 50 - 59 60 - 69 70 - 79 80 - 89 90 - 99 100 - 109 110 - 119 120 - 129 130 - 139 140 - 149 150 - 159 160 - 169 170 - 179 180 - 189 190 - 199 200 - 209 210 - 219 220 - 229 230 - 239 240 - 249 > 249 Total Unknown System Total

Number of Inmates
4 13 22 46 28 44 30 17 13 14
8 7 6 7 2 7 2 5 6 2 6 1 1 2 9 302 0 68 68 370

Percent

Valid Percent

1.1

1.3

3.5

4.3

5.9

7.3

12.4

15.2

7.6

9.3

11.9

14.6

8.1

9.9

4.6

5.6

3.5

4.3

3.8

4.6

2.2

2.6

1.9

2.3

1.6

2

1.9

2.3

0.5

0.7

1.9

2.3

0.5

0.7

1.4

1.7

1.6

2

0.5

0.7

1.6

2

0.3

0.3

0.3

0.3

0.5

0.7

2.4

3

81.6

100

0

18.4

18.4

100

30

Number of Inmates Treated

> 249

- 99 109 119 129 139 149 159 169 179 189 199 209 219 229 239 249

80 - 89

70 - 79

60 - 69

50 - 59

40 - 49

30 - 39

20 - 29

< 20

9 0 100 110 120 130 140 150 160 170 180 190 200 210 220 230 240 -

Case 1:15-cv-12298-NMG Document 35-4 Filed 05/16/16 Page 37 of 67
Figure 6: Distribution of ALT levels at the Start of Treatment
50 45 40 35 30 25 20 15 10
5 0
Baseline ALT Level
HCV Viral Load
Out of 370 inmates treated, 332 (89.7%) inmates had a documented baseline value for the level of HCV RNA in the blood. These values were measured in terms of International Units per milliliter (IU/mL). Baseline HCV RNA levels ranged from as low as 353 IU/mL to as high as 98,400,000 IU/mL. The average HCV RNA level was calculated around 2,363,344.53 IU/mL, whereas the median HCV RNA level was only 1,131,740 IU/mL.
Due to the large percentage of missing data, HCV RNA levels at 12 weeks, 24 weeks, and 48 weeks into treatment could not be assessed. However, results did show that inmates achieved an undetectable viral load (<615 IU/mL) as early as 12 weeks into treatment. Of the 232 inmates who had HCV RNA levels recorded beyond the baseline value, 178 (76.7%) of them achieved an undetectable viral load by the end of treatment. Not enough data was available to summarize the number of inmates who were able to attain a sustained virologic response.
Results regarding the frequency of undetectable HCV viral loads among inmates have been outlined in Table 7.
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Table 7: Undetectable Viral Loads among Inmates Treated

Did Subject Have Undetectable HCV Viral Load?

Valid

No

Yes

Missing

Total Unknown

System

Total

Total

Number of Inmates
54 178 232 43 95 138 370

Percent

Valid Percent

14.6

23.3

48.1

76.7

62.7

100

11.6

25.7

37.3

100

Correlation between HCV Genotype and Success of Treatment
Out of 370 inmates treated, 217 (58.6%) inmates had a documented HCV genotype as well as HCV RNA levels recorded beyond the baseline value. Of the 149 inmates infected with HCV genotype 1, 106 (71.1%) of them achieved an undetectable viral load (<615 IU/mL) by the end of treatment. Of the 68 inmates infected with HCV genotypes 2, 3, or 4, 62 (91.2%) of them were able to achieve a similar success in treatment with an undetectable viral load (<615 IU/mL). Statistical results regarding the correlation between HCV genotype and an inmate’s ability to achieve an undetectable viral load (< 615 IU/mL) have been summarized in Table 8.

Table 8: The Effect of HCV Genotype on HCV Viral Loads

Did Subject Have Undetectable HCV Viral Load?

No Number of Inmates

Valid Percentage within Genotype Yes Number of Inmates

Total

Valid Percentage within Genotype
Number of Inmates

Valid Percentage within Genotype

Genotype

Genotype 1 43

Genotype Other (2, 3, 4)
6

28.90%

8.80%

106

62

71.10%

91.20%

149

68

100%

100%

HIV Co-infection
255 (68.9%) of the 370 inmates on HCV combination therapy had a documented HIV status. 200 (78.4%) were only mono-infected with HCV while 55 (21.6%) inmates

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were co-infected with HIV. Table 9 lists the data involving the HIV co-infection status of inmates on HCV therapy. Figure 7 shows the frequency of patients who were either mono-infected with HCV or co-infected with HCV and HIV.

Table 9: Frequency and Percentage of Inmates Co-infected with HIV

Did Subject Have HIV Coinfection?

Valid Missing

No Yes Total Unknown System Total

Total

Number of Inmates
200 55 255 81 34 115 370

Percent

Valid Percent

54.1

78.4

14.9

21.6

68.9

100

21.9

9.2

31.1

100

Number of Inmates

Figure 7: Distribution of Inmates with HIV/HCV Co-infection
250

200

150

100

50

0

No

Yes

HIV Co-infection

Correlation between HIV Co-infection and Success of Treatment
Out of the 370 inmates on combination therapy, only 165 (44.6%) inmates had a known HIV status and a recorded HCV viral load during or at the end of treatment. Despite the substantial amount of missing information, the recorded data between HIV status and treatment success was compared in an attempt to define any relationship between the two. Out of the 143 inmates who were only mono-infected with HCV, 116 (81.1%) had achieved an undetectable HCV viral load. Out of the 22 inmates who were co-infected with HIV, 12 (54.5%) had achieved an undetectable HCV viral load. Table 10 displays the cross-tabulation of data on whether or not the inmate was infected with HIV and whether or not he/she had reached undetectable HCV RNA levels.

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Table 10: The Effect of HIV Co-infection on HCV Viral Loads

Did Subject Have Undetectable HCV Viral Load?

No Yes Total

Number of Inmates
Valid Percentage within HIV Co-infection Number of Inmates Valid Percentage within HIV Co-infection Number of Inmates

Valid Percentage within HIV Co-infection

HIV Co-infection

No

Yes

27

10

18.90%

45.50%

116

12

81.10%

54.50%

143

22

100%

100%

Treatment Interruptions
223 (60.3%) inmates had documented information on whether or not they had experienced any treatment interruptions. From this known data, 40 (17.9%) inmates did have treatment interruptions while 183 (82.1%) inmates did not. These values and percentages are organized in Table 11.

Table 11: Number of Inmates Who Experienced Treatment Interruptions

Did Subject have any Treatment Interruptions?

Valid Missing

No Yes Total Unknown

System

Total

Total

Number of Inmates
183 40 223
1 146 147 370

Percent

Valid Percent

49.5

82.1

10.8

17.9

60.3

100

0.3

39.5

39.7

100

Early Discontinuation of Treatment
From the total number of inmates on HCV combination therapy, 243 (65.7%) had recorded data on whether or not they had to stop treatment early. 137 (56.4%) inmates had prematurely terminated treatment while 106 (43.6%) inmates did not stop treatment early. Table 12 lists data regarding the amount of inmates who have discontinued treatment before they had completed a full course of therapy.

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Table 12: Early Discontinuation of Treatment among Inmates

Was Treatment Stopped Early?

Valid Missing Total

No Yes Total Unknown System Total

Number of Inmates
106 137 243
6 121 127 370

Percent

Valid Percent

28.6

43.6

37

56.4

65.7

100

1.6

32.7

34.3

100

Reasons for stopping treatment early was input in the database and can be classified into three main categories: poor virologic response to treatment, severe side effects and poor compliance with treatment. According to the protocol followed by MA correctional facilities, if the patient did not reach a 2 log reduction in HCV RNA viral load by the twelfth week into treatment, then that person was discontinued from therapy because he/she was not responding to the medications. Several inmates stopped treatment early for this reason.
As cautioned to the inmates before initiating therapy, HCV treatment may elicit several side effects. These side effects vary in degree and may be difficult to tolerate. Among the most common physical symptoms that were listed as reasons why treatment was stopped early are cotton wool spots, chest pain, rash, visual problems, back pain, and gastrointestinal problems including nausea, vomiting, and diarrhea. The mental health status of some inmates was also affected by the medications; other reasons for discontinuing treatment were anxiety, mood swings, agitation, and neurological symptoms including seizures and shakes. Other side effects which resulted in ending treatment early were anemia, and a decrease in hemoglobin, neutrophils and/or white blood cells. Experiencing severe side effects was the predominant category of reasons why treatment was terminated early.
Before beginning treatment, inmates were advised to avoid any high-risk behaviors as outlined in the “Inmate Treatment Agreement” form. Only a few inmates were recorded as having to end treatment early because of risky behaviors. These behaviors included getting a home-made tattoo, exhibiting maniac behavior, and having a “dirty” urine sample (testing positive for substance abuse) while on therapy. Several inmates also ended treatment early because they were released early from prison and therefore could not complete the full course of therapy.

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Discussion
Over the past decade, hepatitis C has become an increasingly common occurrence in Massachusetts state correctional facilities. In a 2003 report by the Metro West Daily News, it was estimated that of the 10,000 inmates in the Massachusetts state prison system, 3,000 inmates were infected with hepatitis C, accounting for 30% of the male population and 40% of the female population (Hillman, 2003). In an effort to raise awareness of this growing epidemic and prevent the spread of hepatitis C within prisons and the society where many inmates will be released, hepatitis C treatment has become a standard in Massachusetts state correctional facilities. Since its initiation in 1999, over 500 inmates have received some form of treatment for an HCV infection.
In order to monitor the overall progress of treatment among inmates and assess the state of the treatment system in Massachusetts correctional facilities, the HCV database was created between 2004 and 2005 as a means to collect and organize information regarding the demographics, health, and treatment of inmates. In 2005, data on more than 200 inmates was collected and input into the database. By the end of this project, data on a total of 510 inmates was included in the database. This updated data was used to assess the current state of the treatment system as well as the condition of the HCV database. In terms of the treatment system, conclusions can be drawn from the results regarding the general characteristics of inmates who are receiving treatment in Massachusetts state correctional facilities and the overall response of inmates to treatment since the start of combination therapy in August 2002. Additional conclusions concerning the importance of the HCV database and ways in which it can potentially be improved can be made as well.
Characteristics
The characteristics of those inmates who were treated for hepatitis C were summarized according to five different categories. To start with, data collected on the locations of where inmates started treatment showed that a majority of HCV infected inmates were treated at Massachusetts Correctional Institution - Norfolk (78), SouzaBaranowski Correctional Center (71), and Massachusetts Correctional Institution – Shirley (66). A limited number of inmates received treatment at the Massachusetts Alcohol and Substance Abuse Center (2), Old Colony Correctional Center Min (3), Bridgewater State Hospital (4), and Massachusetts Correctional Institution - Plymouth (4). Factors which may have contributed to why certain facilities had more inmates treated than others include the populations within each facility, the percentage of inmates with long enough sentences to qualify for treatment, and the healthcare services and resources available at each facility. For example, with an average daily population of 1250 inmates, the Massachusetts Correctional Institution at Norfolk is the largest facility of its type in the Commonwealth of Massachusetts. In addition, about eighty-percent of the inmate population at the facility is serving time for violent crimes (Massachusetts Department of Correction, 2007). Based on the mere size of the facility and the percentage of inmates with long sentence times, it makes sense that Norfolk currently has the highest number of inmates who have been treated for HCV. The facility with the second highest frequency of inmates treated was Sousa Baranowski which is the state’s newest correctional facility. It is a maximum security prison that offers a full range of educational, vocational, and substance abuse programming. The recent establishment of
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this high security facility as well as the up-to-date healthcare program equally contributes to the high percentage of inmates receiving treatment. Massachusetts Correctional Institution-Shirley was the facility with the third highest frequency of inmates who were treated for HCV. This is likely due to the fact that MCI-Shirley Health Services Unit is fully staffed seven days a week and 24 hours a day. Healthcare includes services in the fields of medicine, dentistry, podiatry, optometry, mental health, psychiatry, psychology, and physical therapy. Inmates from all other Department of Correction facilities are transported as necessary to MCI-Shirley for these services (Massachusetts Department of Correction, 2007).
An analysis of the gender of inmates treated in Massachusetts correctional facilities showed that 96.5% of inmates treated were male while only 3.5% were female. These numbers were very consistent with the actual gender breakdown of the total inmate population in Massachusetts facilities. As of January 1, 2006, a survey from the Department of Corrections counted 8,802 males and 603 females, representing 94% and 6% of the inmate population, respectively (Massachusetts Department of Correction: Research and Planning Division, 2006). Besides the overall low percentage of female inmates in the Massachusetts facilities, it is important to note that the lower number of females receiving treatment can also be attributed to the fact that women often have shorter incarcerations, which exclude them from qualifying for the long course of HCV therapy (Carol Bova, personal communication).
According to the results regarding race/ethnicity of inmates, Caucasians were the most frequently treated race, accounting for 62.9% of all treated inmates with valid data. Hispanic/Latino and African Americans were nearly tied for the second highest race/ethnicity treated with valid percents of 18.5% and 17.7%, respectively. These values are only partially reflective of the breakdown of race amongst Massachusetts inmate populations. Between 1997 and 2006, the proportion of Caucasian inmates decreased from 48% in 1997 to 44% in 2006. The percentage of African American similarly decreased from 29% in 1997 to 27% in 2006. The percentage of Hispanic inmates was the only one to increase from 22% to 27% during this ten-year duration (Massachusetts Department of Correction: Research and Planning Division, 2006). Indeed, it is the Caucasian race that accounts for the majority of the inmate population as well as the inmates treated for HCV. However, a large disparity does exist between the high percentage of Caucasian inmates treated and the lower percentage of Caucasians within the entire inmate population. Likewise, the inmate population percentages of both Hispanics and African Americans are higher than the percentages of Hispanic and African American inmates treated for HCV. This particular data may serve as an incentive for management to reexamine treatment selection protocols. Ideally, knowing the number of inmates infected with HCV as well as the breakdown of their ethnicity would allow for a more direct display of any treatment selection bias. Unfortunately, information from the database only included information on the inmates who were selected for HCV treatment, not for all of the inmates who were infected with this virus, including those who did not apply or qualify for treatment, and the reasons for exclusion.
An analysis of the age at which inmates started treatment showed that the majority of individuals on HCV therapy began treatment in their mid thirties to late forties. The average age of inmates treated was 42.9 while the median was 43 years old. These numbers are fairly consistent with the average age of inmates among
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Massachusetts correctional populations. According to the Department of Corrections survey, the median age of inmates has increased from 33 years in 1997 to 36 years in 2006. Similarly, the mean age of inmates has increased from 34 to 38 years during this ten year period. As of 2006, 39% of Massachusetts inmates are ages 40-64 while 31% are ages 30-39 (Massachusetts Department of Correction: Research and Planning Division, 2006). Because the ages of those inmates who started treatment ranged from as young as 22 to as high as 71 years old, age does not seem to influence HCV treatment eligibility.
Data collected on HCV genotype showed that the majority of inmates were infected with HCV genotype 1 (66.1%). 17.7% of Massachusetts inmates were infected with genotype 3, 11.6% of inmates was infected with genotype 2 and only 4.5% of inmates had genotype 4. At 66.1%, this high percentage of inmates infected with HCV genotype 1 directly correlates with the high prevalence of genotype 1 in the general public. It is believed that HCV genotype 1 accounts for around 70% of hepatitis C cases in the United States (NDDIC, 2006).
Treatment Outcomes
Since August 2002, combination therapy has become the standard form of treatment in Massachusetts state correctional facilities. To summarize the effects of this therapy on the outcome of treatment and to identify potential correlations between inmate characteristics and the success of treatment, various aspects of the treatment process were analyzed.
As a historical indicator of a potential HCV infection, baseline ALT levels were first analyzed to determine whether or not they accurately correlated with HCV infection among inmates. Alanine aminotransferase, or ALT, is an enzyme produced primarily by cells in the liver. In a normal, healthy individual, ALT levels in the blood tend to range between 0 and 40 IU/L; however, this range may vary depending upon the laboratory, gender, and biological make-up of an individual. When cells in the liver are damaged or die, ALT levels tend to increase in the blood. The amount of ALT does not necessarily correlate with the amount of damage to the liver, but it does signal that something may be wrong with the liver. In most individuals with hepatitis C, ALT levels are elevated at least slightly above normal. For approximately 30% of these individuals, though, ALT levels remain normal (Franciscus and Teeter, 2006).
According to the results, baseline ALT levels among inmates ranged from 12 IU/L to 627 IU/L, with the most frequent levels between 30 IU/L and 79 IU/L. The average ALT level was calculated around 90.26 IU/L; however, this value was slightly skewed as a result of the large range in ALT levels among inmates. The median value of 68 IU/L was a more accurate representation of the average baseline. Out of the 302 inmates represented in Table 6, only 43 inmates (14.2%) had baseline ALT levels in the suggested normal range of 0 IU/L to 40 IU/L. The majority of inmates (86%) had what would be considered elevated ALT levels (> 40 IU/L). Although there were a large percentage of inmates with significantly elevated ALT levels, this does not necessarily imply that ALT levels correspond with HCV infection and the potential severity of it. Many inmates may not have experienced elevated ALT levels at all, but rather, had a natural baseline ALT level outside of 40 IU/L. Studies have also shown that there is a poor correlation of ALT levels with disease progression in HCV (Carol Bova, personal
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communication). The only accurate conclusion that can be drawn from these results is that ALT levels may be a fairly good indicator of an HCV infection, but they are not 100% accurate, and thus, should not be the only determinant of HCV infection. Additional tests, such as liver biopsies and HCV viral loads, should be performed to confirm whether or not liver damage is present and/or the HCV virus is present in the blood.
To evaluate the effects of treatment on baseline ALT levels, the original intent of this assessment was to look at changes in ALT levels over time. At 12 weeks and 24 weeks into treatment, reductions in ALT levels were expected to occur in direct correspondence with reductions in the level of HCV RNA in the blood. Unfortunately, there was not enough data to accurately assess ALT levels beyond the baseline measurement.
In order to determine the overall effectiveness of treatment among inmates, changes in the level of HCV RNA were assessed over time. Quantitative HCV RNA tests are used to measure the level of HCV RNA in the blood of an individual with hepatitis C. These tests do not indicate the severity of the disease or the level of damage to the liver, but they do give an exact measurement of the amount of virus in the blood. This value is most often referred to as the viral load. Prior to the start of treatment, quantitative tests are used to establish a baseline HCV RNA level (United States Department of Veterans Affairs, 2007). Values greater than 800,000 IU/mL are referred to as “high” viral loads, whereas values less than 800,000 IU/mL are referred to as “low” viral loads (Franciscus, 2006). These values are an important indication of whether or not patients will have a successful treatment as it is much more difficult to lower the level of virus in patients with “high” viral loads than patients with “low” viral loads (United States Department of Veterans Affairs, 2007).
According to the results of this study, baseline HCV RNA levels varied significantly among inmates, ranging from as low as 353 IU/mL to as high as 98,400,000 IU/mL. Because of the large range, the mean was calculated at a slightly skewed value of 2,363,344.53 IU/mL. It was more reasonable to consider the average baseline HCV RNA level around the slightly lower median value of 1,131,740 IU/mL. Of the inmates included in the aforementioned range of baseline HCV RNA levels, the majority had what would be considered “high” viral loads. Based on this data, no accurate conclusions can be drawn regarding the severity of HCV infection among inmates with higher HCV RNA levels, or whether or not there is any significance in the fact that most inmates had “high” viral loads. This data may, however, serve as an indicator for predicting which inmates have a considerably lower chance of responding well to treatment and achieving lower levels of virus within their system.
To assess the accuracy of this prediction, changes in HCV RNA levels needed to be measured over time. A patient responding well to treatment would achieve a 2-log reduction in the level of HCV RNA within 12 weeks. Unfortunately, there was not enough data to assess HCV RNA levels at 12 weeks, 24 weeks, or 48 weeks into treatment. The only factor which could accurately be assessed beyond baseline HCV RNA levels was the number of inmates who were able to successfully achieve an undetectable viral load. An undetectable viral load can be defined as the complete elimination of HCV RNA in the blood or a level of HCV RNA too low for a quantitative
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assay to detect. In either case, an undetectable viral load is reported in labs as < 615 IU/mL (United States Department of Veterans Affairs, 2007).
Results showed that inmates were able to achieve undetectable viral loads (< 615 IU/mL) as early as 12 weeks into treatment. Success this early into treatment suggests that inmates either had “low” baseline viral loads or responded well to treatment as a result of health factors, viral characteristics, or overall good compliance. Of the 232 inmates with HCV RNA levels recorded beyond baseline, a total of 178 (76.7%) of them were able to achieve an undetectable viral load at least at some point during treatment. These numbers are a good indication that treatment was successful among most inmates during therapy. However, a completely successful treatment is measured in terms of a sustained virologic response. For most inmates, HCV RNA levels were not recorded beyond the end of therapy. Consequently, it could not be determined, based on the amount of available information, as to whether or not inmates who attained an undetectable viral load (< 615 IU/mL) during therapy were able to maintain the same level of virus six months later.
For those 54 (23.3%) inmates in Table 7 who were unable to achieve an undetectable viral load, a lack of success can be accounted for by a number of factors including “high” viral loads at the start of treatment, problems associated with the medication, or alternative health and viral aspects which may have hindered the inmate’s response to treatment. Particular factors addressed in this project were HCV genotype, HIV co-infection, and problems associated with therapy.
An analysis was first conducted to determine whether or not HCV genotype had any effect on an inmate’s ability to achieve an undetectable viral load (< 615 IU/mL). Studies have shown that variations in HCV genotype are an important indication of how a patient will respond to interferon therapy. HCV genotype 1 accounts for approximately 75% of HCV infections in the United States; however, patients infected with this genotype tend to have the most difficulty responding to interferon. Patients with genotypes 2 and 3, on the other hand, account for only 10 to 20 percent of cases in the United States and are the most likely to respond to interferon therapy (NDDIC, 2006). HCV infections caused by genotype 4 are rarely seen in the United States, but reports show that these patients have a similar difficulty in responding to interferon therapy as those infected with genotype 1 (Herrine, 2002). To account for these differences in HCV genotype and response to therapy, Massachusetts protocol requires that inmates with more problematic genotypes such as 1 and 4 receive a longer period of treatment. Whether or not this extension in treatment length actually helps inmates to achieve an undetectable viral load was the focus of the analysis.
According to the results, there were 217 inmates with a documented HCV genotype who also had recorded HCV RNA levels measured beyond the baseline value. Of the 149 inmates infected with HCV genotype 1, 106 (71.1%) were able to achieve an undetectable viral load (< 615 IU/mL) at some point during treatment. By comparison, 62 (91.2%) of the 68 inmates infected with HCV genotypes 2, 3, or 4, were able to achieve a similar HCV RNA level during treatment. Based on the shear number of inmates infected with each genotype, it is evident that the trends in HCV infection within prisons are accurately representative of the current trends in HCV infection throughout the United States. However, no definitive conclusions can be drawn as to whether or not genotype had any effect on the inmate’s abilities to achieve undetectable viral loads (<
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615 IU/mL). The percentages suggest that inmates with genotypes 2, 3, and 4 are more likely to achieve an undetectable viral load, but there was also a much smaller number of inmates infected with these genotypes than those infected with genotype 1. A larger set of inmates infected with genotypes 2, 3, or 4 could have caused a drastic change in the percentage that was able to achieve an undetectable viral load (< 615 IU/mL). All in all, there does not appear to be any significant correlation between HCV genotype and the success of treatment. Inmates infected with HCV genotypes 1 or 4 may not respond as well to interferon therapy, but alterations in the length of treatment seemed to help the majority of inmates achieve an undetectable viral load regardless of their genotype.
An additional factor which may account for the unsuccessful outcome of inmates in response to treatment is HIV co-infection. Like hepatitis C, HIV has been a long time problem in the prison system. In a 2003 report by the Metro West Daily News, it was estimated that of the 10,000 inmates in the Massachusetts state prison system, 300 inmates are HIV positive. Of these inmates, 70% are co-infected with HCV. This number accounts for 10% of the estimated 3,000 inmates infected with hepatitis C (Hillman, 2003). To determine whether or not this percentage was reflected in the number of inmates receiving treatment in Massachusetts state correctional facilities, the prevalence of HIV co-infection among inmates in the HCV database was assessed. Results showed that of the 255 inmates with a documented HIV status, 55 (21.6%) were HIV positive. This value represents a slightly higher percentage of inmates with an HCV/HIV co-infection than originally predicted in 2003, but this could be due to a number of factors including a lack of available data regarding HIV status, an increase in the number of inmates with an HCV/HIV co-infection in the Massachusetts prison system, or treatment preference. Under the Massachusetts protocol, inmates co-infected with HIV and HCV are moved to the top of the priority list regardless of when they were diagnosed. This preference, as well as the prevalence of HIV/HCV co-infection in Massachusetts state correctional facilities, is what is most likely reflected in the percentage of inmates who have an HIV co-infection and have received treatment since August 2002.
For most patients with an HIV co-infection, the severity of the HCV infection is amplified. Damage to the liver occurs more rapidly, HCV RNA levels in the blood are typically higher, and response to treatment is compromised. In fact, treatment for patients co-infected with HIV usually requires a much longer time period (6-12 months) and a number of extra precautions not necessarily taken in a normal therapy (CDC, 2005; CDC, 2007). For the inmates with an HIV co-infection in the HCV database, an analysis was conducted to determine whether or not HIV co-infection had any effect on an inmate’s ability to achieve an undetectable viral load (< 615 IU/mL). According to the results, 165 inmates with a documented HIV status as well as HCV RNA levels recorded beyond the baseline value were taken into consideration. Of the 143 inmates infected with only HCV, 81.1% were able to achieve an undetectable viral load (< 615 IU/mL). This value is reflective of the results of the previous HCV RNA analysis and further confirms the effectiveness of combination therapy towards a successful treatment. By comparison, only 54.5% of the 22 inmates co-infected with HIV were able to achieve a similar undetectable viral load (< 615 IU/mL). These results suggest that an HIV coinfection at least slightly inhibits an inmate’s ability to achieve an undetectable viral load. Out of 22 inmates, there were still a reasonable number of inmates that were able to
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respond to treatment. The limited percentage is likely just a reflection of the complications caused by HIV co-infection during treatment. Further data would need to be collected in order to make any more definitive conclusions regarding the correlation between HIV co-infection and the success of treatment. However, based solely on these results, inmates with an HIV co-infection should not be excluded based on this health criterion, alone.
Besides HCV genotype and HIV co-infection, a major factor which may have contributed to the unsuccessful outcome of inmates in response to treatment is complications associated with combination therapy. In the current treatment system, complications are addressed by either a reduction in the dosage of medication or an entire discontinuation of treatment. The solution usually depends upon the nature and severity of the problem. To determine the extent to which these events have occurred since the start of combination therapy, treatment interruptions and early discontinuations in treatment were each individually assessed.
Treatment interruptions can be defined as brief periods of time in which treatment is altered in some manner. These are usually the result of side effects that require alterations in the dosage of medication or a movement between correctional facilities. Results from this study were based on the 233 inmates who had a documented indication of whether or not they had incurred an interruption during treatment. For 183 (82.1%) of these inmates, treatment was administered uninterrupted. This suggests that the majority of inmates either completed treatment successfully or discontinued treatment early as a result of a severe problem. For the remaining 40 (17.9%) inmates, at least one interruption was noted at some point during treatment. Most of these interruptions were recorded as changes in the dosage of interferon and/or ribavirin. Based on these results, it is evident that treatment interruptions were an uncommon occurrence for most inmates on combination therapy. There is no clear indication, however, as to whether or not inmates who experience interruptions in treatment still have the potential to complete treatment successfully or are more likely to cease treatment early. The only conclusion that can be drawn from this information is that for any given hepatitis C treatment, at least a few minor interruptions are to be expected. Medication dosages are not standard for every patient and may require slight variations depending upon individual responses.
Early discontinuation is normally advised for those inmates who experience more severe complications in response to therapy or have an inability to cooperate with treatment. Discontinuation of treatment is defined by a complete cessation in the administration of interferon and ribavirin. Like undetectable viral loads (< 615 IU/mL), the number of inmates who stop treatment early is a fair measure of the success of combination therapy among inmates. According to the results of this study, 243 inmates had a valid indication of whether or not their treatment was stopped early. For as many as 137 (56.4%) of these inmates, treatment was prematurely terminated. This was due primarily to complications with therapy, which appeared to be the most common reason for an inmate’s inability to achieve an undetectable viral load (< 615 IU/mL). This data suggests that although combination therapy is successful among a large percentage of inmates, it is evidently just as problematic for a similar proportion of inmates. Because these results are based on a unique set of inmates with valid data, no reliable comparisons can be made between these results and those for the percentage of inmates who were able to achieve an undetectable viral load.
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A qualitative assessment of the reasons for ending treatment early showed that termination for most inmates was the result of a specific, individual problem associated with therapy. Broad categories such as poor virologic response, severe side effects, and poor compliance with treatment were used to classify each specific problem and eliminate the large variation in data. The original intention of this assessment was to qualitatively as well as quantitatively analyze the frequency of each particular problem. An understanding of why most inmates are unable to achieve an undetectable viral load would not only contribute to the education of other inmates preparing for hepatitis C treatment, but it would help healthcare managers to prepare appropriately for any potential problem. Unfortunately, there was a limited amount of data from which accurate results or conclusions could be drawn.
Importance of Database
A hepatitis C treatment database is valuable tool for the collection, storage, and organization of an abundant amount of information. As a result of the data collected, demographic summaries can be periodically performed to characterize those inmates who are selected for HCV treatment. Specifically, this report has revealed a slight bias in the proportion of race/ethnicity of inmates who have been eligible for treatment. This finding was also revealed in the 2005 analysis of Massachusetts inmate demographics (Kelly, 2005). The managers of the HCV treatment program can use inmate characteristic summaries like these as a reference to minimize any intentional or unintentional bias which may be a product of the current screening/evaluation protocols and treatment qualifications.
In addition to inmate characteristics, data assessments regarding treatment response and outcomes can also provide direction for the improvement of Massachusetts correctional facility protocols for the management of hepatitis C. For example, as recently as 2005, the screening process for HCV treatment eligibility was different from the currently implemented system. At that time, elevated ALT levels (> 60 IU/L) were needed in order for an inmate to continue with the treatment evaluation process and get a liver biopsy (Kelly, 2005). However, it was later realized that many HCV infected African Americans would still have normal ALT levels (0-40 IU/L) even if they were seriously ill with HCV (Carol Bova, personal communication). As a result of this finding, alterations were made to the protocol in order to eliminate ALT eligibility requirements. Tests for HCV antibody and HCV RNA levels are now used to determine whether or not an inmate qualifies for a liver biopsy and possibly HCV therapy. This alteration will ideally minimize the exclusion of African Americans from treatment in Massachusetts correctional facilities. In this case, summaries of the demographics and outcomes of inmates revealed an issue which may have never been exposed or dealt with had their not been a system for collecting, organizing, and analyzing treatment data.
Beyond the actual process and management of the treatment system, data regarding treatment outcomes and response can serve as an important indicator of whether or not therapy is successful and whether or not this HCV treatment system is worth continuing. For instance, if only a small percentage of inmates were successfully responding to therapy, then it may be in the best interest of the Massachusetts correctional health system to invest their money and limited budget in the treatment and
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care of other medical ailments. However, results from this study have shown that HCV treatment in Massachusetts correctional facilities has been very effective.
For inmates who are unable to respond successfully to treatment, data collection can only help to further improve healthcare facilities in prisons. Information regarding treatment complications such as poor response to therapy and medication side effects will keep the staff informed of common medical problems associated with HCV treatment and facilitate them in being more prepared and better equipped to help patients cope with difficult symptoms while on treatment. This information may also be used to help educate inmates on what to expect during treatment prior to the start of therapy.
Recommendations
One of the primary constraints of this project was the limited amount of available data. For all inmates, information was extracted directly from individual hepatitis C worksheets. Any areas that were left blank or had no indication of an unknown or nonapplicable variable were correspondingly left blank in the database. These blank spaces were accumulatively referred to by SPSS as “missing system” data.
For most inmates, data was missing in at least one or two different fields. However, for an even larger proportion of inmates, data was missing in nearly every field. Variables such as sustained viral load measures and the inmate’s history of substance abuse and health conditions were recorded for less than half the inmates included in the database. This factor not only affected the accuracy of the analyses performed for this project, but also limited the number of fields that could be assessed. In order to ensure the quality and reliability of the database as well the accuracy of statistical analyses based on information in the database, improvements must be made in the collection and recording of data.
One major problem that accounted for the majority of “missing system” data was the irregularity in data recording on the hepatitis C worksheets. Some HIV/Hepatitis C case managers indicated unknown and non-applicable fields on the worksheet with an N/A, an Ø, or a brief note. Other case managers simply left the areas blank with no indication as to whether or not information was unknown, missing, or not applicable. As a standard procedure for data collection, these blank fields were left blank in the database, but whether or not data was actually missing from these fields was unclear.
In order to avoid confusion and future issues like these, it would be ideal for all case managers to follow a standard protocol. This does not mean that data needs to be recorded in exactly the same way for every inmate, but it should be clear in every area of the hepatitis C worksheet as to whether or not data is known, unknown, missing, or not applicable. Regularity among the hepatitis C worksheets would potentially help to eliminate a large proportion of “missing system” data in the database, particularly in areas such as health conditions, mental health conditions, and history of substance abuse and alcohol abuse.
The only other major problem that accounted for “missing system” data and altered the outcome of many of the data analyses conducted for this project was the extent of missing lab results. For some inmates, lab results were extensive. Values were recorded in the hepatitis C worksheet for nearly every lab prior to the start of treatment and during treatment. For the majority of inmates, however, lab results were nearly
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nonexistent. Baseline levels were recorded for the required labs, but few values were recorded beyond the start of treatment. In particular, HCV RNA levels 6 months following treatment were missing for nearly every inmate. Less than a quarter of them had any note of a sustained virologic response. The consequences of this missing data were noted primarily during this project in the inability to monitor treatment progress and success among inmates.
As a suggestion to improve the collection of lab data, specifically during and following treatment, the correctional health system may want to consider implementing a stricter data collection system. Any inmate who is receiving treatment for hepatitis C should be closely monitored both during treatment and six months following treatment. Case managers or other health care personnel within the individual facilities should help to ensure during this time that necessary labs are performed at the required times. Lab results recorded immediately following the lab will help to guarantee that data is not missing from the hepatitis C worksheet.
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Effectiveness of Needle Disinfection among Injecting Drug Users. Journal of Acquired Immune Deficiency Syndromes, 7(7), 760-766. Ward, R. P. and Kugelmas, M. (15 August 2005). Using Pegylated Interferon and Ribavirin to Treat Patients with Chronic Hepatitis C. American Family Physician, 72(4), 655.
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Appendix A: Hepatitis C Worksheet
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Appendix B: “Inmate Agreement” Form
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Appendix C: Example of an Original Inmate Treatment Record
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Appendix D: Copy of First Data Collection Form
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Case 1:15-cv-12298-NMG Document 35-18 Filed 05/16/16 Page 1 of 2

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

JEFFREY FOWLER, PAUL WHOOTEN, MICHAEL TURNER, and MICHAEL FITZPATRICK, on behalf of themselves and all others similarly situated,
Plaintiffs,
v.
THOMAS TURCO, Commissioner of Massachusetts Department of Correction, in his official capacity, and MASSACHUSETTS PARTNERSHIP FOR CORRECTIONAL HEALTHCARE, INC.,
Defendants.

C.A. NO. 1:15CV12298

AFFIDAVIT OF JEFFREY FOWLER
I, Jeffrey Fowler, do hereby swear and depose:
1. I am a prisoner in the custody of the Massachusetts Department of Correction. I am serving a life sentence without the possibility of parole.
2. I have had Hepatitis C, genotype 1A, for over 25 years. I have been told by my providers that I have evidence of liver cirrhosis.
3. I was treated with combination therapy in 1999-2000. I suffered side effects of a low white blood cell count (anemia) and my viral load did not come down enough so the treatment was stopped, and I was deemed a "non-responder" to treatment.
4. After being deemed a non-responder my Hepatitis C was basically forgotten about by my medical providers. They did no further testing that they shared with me and when I brought up that I still was infected with hepatitis C, I was told there was nothing that could be done.
5. In or around the late 2000s, when I finally convinced a Nurse Practitioner to check my viral load and order a complete blood count, I was told that "the committee" denied the request.

Case 1:15-cv-12298-NMG Document 35-18 Filed 05/16/16 Page 2 of 2
6. In 2012, after triple therapy was FDA-approved, I had a teleconference with Dr. Mutinga at Lemuel Shattuck Hospital and he believed that another liver biopsy would be beneficial. I didn't receive the second liver biopsy until August of 2013.
7. During this time I was suffering from extreme fatigue and felt drawn out all the time.
8. I was ultimately approved for triple therapy and began it in March or April of 2014. It was stopped in the end of August 2014. I was again a non-responder to treatment. My viral load came down at first, but it went back up. I lost thirty-five pounds during the treatment because I felt sick all the time. This medication regimen was very hard on my body. During the treatment, I had body aches and cold sweats, I became depressed, I developed sores in my mouth, and I had to take a Neupagen shot once a week to boost my white blood cell count.
9. Given my history and disease I was told that I would be a "high priority" for the newer treatment, but I am still waiting. I was told that the "cure rate" with the new medication is close to 100%, but I have not received it.
10. In February of 2015, I was told that my APRI score (0.38) and liver biopsy results did not meet MPCH criteria for further evaluation, even though MPCH decided to treat me with triple therapy based on those same biopsy results.
11. In March of 2015, lab tests were done and my APRI score had risen to 0.74.
12. In February of 2016, MPCH finally drew my blood again for lab tests. The lab numbers were worse than they had ever been before. My viral load was the highest it has ever been, and my ALT was over 180, when it had never been over 100 in any of the previous tests. The FibroTest had me at an F3 level of fibrosis, and an A3 level of inflammation.
13. I have been having abdominal pain for the past eight months, and a Lemuel Shattuck Hospital provider told me that the pain is explained by the high labs.
14. In May of 2016 I had a teleconference with the GI service at Lemuel Shattuck Hospital, where it was recommended that I be treated with Harvoni. I was told that LSH doctors would send this paperwork to the prison, but I am still waiting for treatment and do not know if the GI specialist# s recommendation has been or will be approved.
Sworn to upon the pains and penalties of perjury this 13th day of May, 2016.
/s/ Jeffrey Fowler Jeffrey Fowler
2

Case 1:15-cv-12298-NMG Document 35-19 Filed 05/16/16 Page 1 of 2

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

JEFFREY FOWLER, PAUL WHOOTEN, MICHAEL TURNER, and MICHAEL FITZPATRICK, on behalf of themselves and all others similarly situated,
Plaintiffs,
v.
THOMAS TURCO, Commissioner of Massachusetts Department of Correction, in his official capacity, and MASSACHUSETTS PARTNERSHIP FOR CORRECTIONAL HEALTHCARE, INC.,
Defendants.

C.A. NO. 1:15CV12298

AFFIDAVIT OF PAUL WHOOTEN
I, Paul Whooten, do hereby swear and depose:
1. I am a prisoner in the custody of the Massachusetts Department of Correction.
2. I have Hepatitis C.
3. Medical providers have advised me that I have Genotype 1a and 2b of the Hepatitis C virus.
4. I was previously treated for Hepatitis C in the mid-2000s, with Interferon and Ribavirin. I went through all 48 weeks of treatment and had obtained a viral response at that time, but the virus returned a few weeks later.
5. I had my most recent liver biopsy in 2011, which concluded that my liver fibrosis was at Stage 3 out of 6 on the Ishak scale.
6. I tried to obtain triple therapy (Interferon, Ribavirin, and either Teleprevir or Boceprevir) from the DOC when it became the standard. In July of 2013, MPCH staff advised me that because of my date of incarceration, which was deemed to be March of 2013, I would not even be considered for treatment until April of 2014.

Case 1:15-cv-12298-NMG Document 35-19 Filed 05/16/16 Page 2 of 2 7. I had actually been in DOC custody since 2011, as a pretrial detainee. At that time, I was
told that Hepatitis C treatment was not available to me because of my pretrial status. March 2013 marked the beginning of my sentence, but I was already in DOC custody. 8. I have not had a gastroenterology consult since arriving in the DOC. Sworn to upon the pains and penalties of perjury this 12th day of May, 2016. /s/ Paul Whooten Paul Whooten
2

Case 1:15-cv-12298-NMG Document 35-20 Filed 05/16/16 Page 1 of 2

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

JEFFREY FOWLER, PAUL WHOOTEN, MICHAEL TURNER, and MICHAEL FITZPATRICK, on behalf of themselves and all others similarly situated,
Plaintiffs,
v.
THOMAS TURCO, Commissioner of Massachusetts Department of Correction, in his official capacity, and MASSACHUSETTS PARTNERSHIP FOR CORRECTIONAL HEALTHCARE, INC.,
Defendants.

C.A. NO. 1:15CV12298

AFFIDAVIT OF MICHAEL TURNER
I, Michael Turner, do hereby swear and depose:
1. I am a prisoner in the custody of the Massachusetts Department of Correction. I am due to be released in 2021 or 2022. I become eligible for parole in 2017 or 2018.
2. I have Hepatitis C.
3. According to my medical providers, I have Genotype 1b of the Hepatitis C virus.
4. My most recent liver biopsy was in 2011. I was found to have liver fibrosis at stage 3 out of 6.
5. I was treated for Hepatitis C in 2012, while in DOC custody. The treatment was Pegylated Interferon and Ribavirin. The treatment was discontinued, because it was not working. I was also having side effects from the medications.
6. In April 2014, I consulted with MPCH providers about treatment options. After discussing triple therapy and the potential for new, Interferon-free regimens that were coming soon, I agreed that we should wait until the new regimens had arrived.
7. In November 2014, I submitted a medical grievance requesting Hepatitis C treatment with the new medications. I was told that I was not eligible for treatment under MPCH# s

Case 1:15-cv-12298-NMG Document 35-20 Filed 05/16/16 Page 2 of 2
current guidelines. It was also suggested that my liver function was normal, despite all the previous tests and my previously having been found eligible for treatment. 8. At that time, MPCH providers also advised that my APRI score was 0.621 and that their treatment protocol required that I have an APRI score of greater than or equal to 1.0. The APRI score was based on blood tests that were done in April 2014. 9. On September 1, 2015, I had a video appointment with a gastroenterologist. She advised me that I was approved for Hepatitis C treatment. She said I would be starting on the medications in the following week. 10. Since that time I have asked my MPCH providers about the schedule for treatment, but I was told there is no specific time when I will start treatment. In November 2015 and again in April 2016, I was told that I am on a waiting list and that I am lower priority on that list. 11. I had a FibroTest and ActiTest $ blood tests $ taken in January 2016. I had severe liver fibrosis (score of 0.78, or F4 on a scale of 0 $ 4), and some inflammation activity (score of 0.47, or A1-A2 on a scale of A0-A3).
Sworn to upon the pains and penalties of perjury this 12th day of May, 2016.
/s/ Michael Turner Michael Turner
2

Case 1:15-cv-12298-NMG Document 35-21 Filed 05/16/16 Page 1 of 3

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

JEFFREY FOWLER, PAUL WHOOTEN, MICHAEL TURNER, and MICHAEL FITZPATRICK, on behalf of themselves and all others similarly situated,

Plaintiffs, v.

C.A. NO. 1:15CV12298

THOMAS TURCO, Commissioner of Massachusetts Department of Correction, in his official capacity, and MASSACHUSETTS PARTNERSHIP FOR CORRECTIONAL HEALTHCARE, INC.,

Defendants.

AFFIDAVIT OF MICHAEL FITZPATRICK I, Michael Fitzpatrick, do hereby swear and depose:

1. I am a prisoner in the custody of the Massachusetts Department of Correction. I am due to be released in September of 2016.

2. I have Hepatitis C.

3. I suffer from advanced cirrhosis of the liver brought on by uncured Hepatitis C, genotype 1a. I also suffer from GAVE disease, which is associated with cirrhosis of the liver and causes me to bleed from my rectum. I have had esophageal varices, which occur when blood can't get through the liver and backs up in veins and arteries of the esophagus. Varices can rupture, which can be fatal if I don't receive immediate emergency medical care.

4. When I entered DOC custody in 2010, I told my medical providers that I had Hepatitis C and was seeking treatment.

5. In April of 2012, I was seen by an infectious disease specialist from Lemuel Shattuck Hospital. She noted that my viral load was high, and a FibroSure test showed cirrhosis of the liver. She recommended putting me ! on the top of the list for triple therapy." She repeated this recommendation in June of 2012.

6. A year passed after that initial recommendation, before I finally began triple therapy in April of 2013.

Case 1:15-cv-12298-NMG Document 35-21 Filed 05/16/16 Page 2 of 3
7. The treatment began with combination therapy (Interferon and Ribavirin) and Boceprevir was added later, in May of 2013. I suffered from multiple side effects which worsened with time, including severe pancytopenia. The treatment was stopped in July 2013.
8. In April of 2014, a gastroenterologist concluded that I was a candidate for interferon-free therapy for Hepatitis C, and that the ! treatment would include simeprevir [Olysio] and sofosbuvir [Sovaldi] for 12 weeks with minimal side effects."
9. I was hospitalized in May of 2014 with explosive diarrhea and fevers. A gastroenterologist noted that I continued to have esophageal varices, a CT scan showed signs of portal hypertension and splenomegaly, and a FibroSure test suggested that I had cirrhosis. My APRI score at the end of my hospitalization was 3.76.
10. In February of 2015, I was hospitalized at Lemuel Shattuck Hospital for an infection. At this point, I was periodically spitting up blood. I was told that I needed to see a liver specialist in order to manage treatment of my hepatitis C. The discharge papers recommended an appointment with gastroenterology in 3-4 weeks. This appointment never took place.
11. In or around April of 2015, I received disciplinary report for possession of homebrew. MPCH providers informed me that the disciplinary report made me ineligible for Hepatitis C treatment for twelve months.
12. In August of 2015 I was rushed to Norwood Hospital emergency room because I was vomiting blood and had bloody stool. Imaging found evidence of portal hypertension and varices, and it was thought that the bleeding was caused by GAVE disease. I was given medication to help with the varices but I have not been provided care for the cause of the varices, Hepatitis C.
13. In late December 2015 I was taken to the emergency room again, with abdominal pain, vomiting, and a low platelet count. The emergency room doctor evidently consulted with the prison medical staff about my Hepatitis C and treatment for it, and he was told that I needed to be not using alcohol for one year before they would consider treatment. They said it had been eight months.
14. I was readmitted four days later, in January 2016, with bloody stool, spitting up blood, vomiting, and severe abdominal pain. Imaging found esophageal, gastric, and splenic varices. I was transferred from Norwood Hospital to Lemuel Shattuck Hospital. I remained inpatient for weeks, and ultimately I was sent to Boston Medical Center for surgery on my stomach, for complications from the GAVE disease.
15. Despite all the medical complications I have had because of untreated Hepatitis C, I still am waiting for treatment. MPCH has not taken any action to have me receive the treatment I need and it appears they won't. They are waiting for me to be released or die. Either way, they will not have to spend the money.
2

Case 1:15-cv-12298-NMG Document 35-21 Filed 05/16/16 Page 3 of 3 Sworn to upon the pains and penalties of perjury this 15th day of May, 2016.
/s/ Michael Fitzpatrick Michael Fitzpatrick
3

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 Case: 1:15-cv-12298-NMG As of: 03/28/2019 04:29 PM EDT 1 of 11
CLOSED,STAYED
United States District Court District of Massachusetts (Boston) CIVIL DOCKET FOR CASE #: 1:15−cv−12298−NMG

Fowler et al v. Turco et al Assigned to: Judge Nathaniel M. Gorton Cause: 42:1983 Prisoner Civil Rights Plaintiff Emilian Paszko on behalf of themselves and all others similarly situated TERMINATED: 07/01/2016
Plaintiff Jeffrey Fowler on behalf of themselves and all others similarly situated
Plaintiff Paul R. Whooten
Plaintiff

Date Filed: 06/10/2015 Date Terminated: 03/21/2018 Jury Demand: Defendant Nature of Suit: 550 Prisoner: Civil Rights Jurisdiction: Federal Question
represented by Jonathan Shapiro Shapiro & Teitelbaum LLP 90 Canal Street Boston, MA 02114−2022 617−742−5800 Fax: 617−742−5858 Email: jshapiro@jsmtlegal.com LEAD ATTORNEY ATTORNEY TO BE NOTICED
Joel H. Thompson Prisoners' Legal Services 50 Federal Street, 4th Floor Boston, MA 02110 617−482−2773 Fax: 617−451−6383 Email: jthompson@plsma.org ATTORNEY TO BE NOTICED
represented by Jonathan Shapiro (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
Tatum A. Pritchard Prisoners' Legal Services 50 Federal Street, 4th Floor Boston, MA 02110 617−482−2773 Fax: 617−451−6383 Email: tpritchard@plsma.org LEAD ATTORNEY ATTORNEY TO BE NOTICED
Joel H. Thompson (See above for address) ATTORNEY TO BE NOTICED
represented by Tatum A. Pritchard (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
Joel H. Thompson (See above for address) ATTORNEY TO BE NOTICED

Case: 1:15-cv-12298-NMG As of: 03/28/2019 04:29 PM EDT 2 of 11

Michael Turner

represented by Tatum A. Pritchard (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED

Joel H. Thompson (See above for address) ATTORNEY TO BE NOTICED

Plaintiff
Michael Fitzpatrick TERMINATED: 05/22/2018

represented by Joel H. Thompson (See above for address) ATTORNEY TO BE NOTICED

V. Defendant Carol Higgins O'Brien TERMINATED: 04/15/2016
Defendant Massachusetts Partnership for Correctional Healthcare LLC

represented by Carrie M. Benedon Office of the Attorney General Martha Coakley One Ashburton Place Boston, MA 02108 617−963−2080 Fax: 617−727−5785 Email: carrie.benedon@state.ma.us TERMINATED: 03/25/2019 LEAD ATTORNEY ATTORNEY TO BE NOTICED
J. David Hampton Office of the Attorney General Insurance & Financial Services One Ashburton Place 18th Floor Boston, MA 02108 617−963−2572 Fax: 617−727−3076 Email: david.hampton@massmail.state.ma.us TERMINATED: 03/25/2019 ATTORNEY TO BE NOTICED
Janna J. Hansen Office of the Attorney General Trial Division One Ashburton Place Boston, MA 02108 617−963−2812 Fax: 617−727−3076 Email: janna.hansen@state.ma.us ATTORNEY TO BE NOTICED
represented by William J. Flanagan Morrison, Mahoney, & Miller LLP 250 Summer Street Boston, MA 02210−1181 617−439−7500 Fax: 617−342−4887 Email: jflanagan@morrisonmahoney.com LEAD ATTORNEY ATTORNEY TO BE NOTICED

Case: 1:15-cv-12298-NMG As of: 03/28/2019 04:29 PM EDT 3 of 11

Curtis L.S. Carpenter Morrison Mahoney LLP 250 Summer Street Boston, MA 02210 617−439−7589 Fax: 617−342−4841 Email: ccarpenter@morrisonmahoney.com TERMINATED: 02/12/2018 ATTORNEY TO BE NOTICED

Tory A. Weigand Morrison, Mahoney, & Miller LLP 250 Summer Street Boston, MA 02210−1181 617−737−8827 Fax: 617−342−4947 Email: tweigand@morrisonmahoney.com ATTORNEY TO BE NOTICED

Defendant
Thomas Turco Commissioner of the Massachusetts Department of Correction

represented by Carrie M. Benedon Office of the Attorney General One Ashburton Place Boston, MA 02108 617−963−2080 Fax: 617−727−5785 Email: carrie.benedon@state.ma.us TERMINATED: 03/25/2019 LEAD ATTORNEY ATTORNEY TO BE NOTICED

J. David Hampton (See above for address) TERMINATED: 05/25/2016 LEAD ATTORNEY ATTORNEY TO BE NOTICED

Janna J. Hansen (See above for address) TERMINATED: 07/12/2018 LEAD ATTORNEY PRO HAC VICE ATTORNEY TO BE NOTICED

Anne M. McLaughlin Attorney General's Office 18th Floor One Ashburton Place Boston, MA 02108 617−727−2200 Email: anne.m.mclaughlin@state.ma.us TERMINATED: 03/26/2019 ATTORNEY TO BE NOTICED

Stephen G. Dietrick MA Department of Correction Legal Division 70 Franklin Street Suite 600 Boston, MA 02110 617−727−3300 Fax: 617−727−7403 Email: Stephen.Dietrick@massmail.state.ma.us ATTORNEY TO BE NOTICED

Case: 1:15-cv-12298-NMG As of: 03/28/2019 04:29 PM EDT 4 of 11

Thomas Vincent DiGangi Massachusetts Attorney General's Office 18th Floor, Room 1813 1 Ashburton Place Boston, MA 02108 6177−727−2593 Email: tom.digangi@massmail.state.ma.us TERMINATED: 01/19/2017 ATTORNEY TO BE NOTICED
Timothy D. Hartnett Office of the Attorney General One Ashburton Place Boston, MA 02108 617−963−2915 Email: timothy.hartnett@state.ma.us TERMINATED: 03/25/2019 ATTORNEY TO BE NOTICED

Date Filed 06/10/2015
06/10/2015
06/10/2015
07/01/2015 07/07/2015 07/21/2015 07/27/2015 07/31/2015 08/06/2015 08/06/2015 08/07/2015

# Docket Text
1 COMPLAINT against All Defendants Filing fee: $ 400, receipt number 0101−5601831 (Fee Status: Filing Fee paid), filed by Jeffrey Fowler, Emilian Paszko. (Attachments: # 1 Civil Cover Sheet, # 2 Category Form)(Shapiro, Jonathan) (Attachment 2 replaced on 6/10/2015) (Burgos, Sandra). (Attachment 1 replaced on 6/10/2015) (Burgos, Sandra). (Entered: 06/10/2015)
2 ELECTRONIC NOTICE of Case Assignment. Judge Nathaniel M. Gorton assigned to case. If the trial Judge issues an Order of Reference of any matter in this case to a Magistrate Judge, the matter will be transmitted to Magistrate Judge Donald L. Cabell. (Abaid, Kimberly) (Entered: 06/10/2015)
3 Summons Issued as to All Defendants. Counsel receiving this notice electronically should download this summons, complete one for each defendant and serve it in accordance with Fed.R.Civ.P. 4 and LR 4.1. Summons will be mailed to plaintiff(s) not receiving notice electronically for completion of service. (Burgos, Sandra) (Entered: 06/10/2015)
4 NOTICE of Appearance by William J. Flanagan on behalf of Massachusetts Partnership for Correctional Healthcare LLC (Flanagan, William) (Entered: 07/01/2015)
5 WAIVER OF SERVICE Returned Executed by Emilian Paszko, Jeffrey Fowler. Carol Higgins O'Brien waiver sent on 6/16/2015, answer due 8/17/2015. (Shapiro, Jonathan) (Entered: 07/07/2015)
6 NOTICE of Appearance by Carrie M. Benedon on behalf of Carol Higgins O'Brien (Benedon, Carrie) (Entered: 07/21/2015)
7 NOTICE of Appearance by J. David Hampton on behalf of Carol Higgins O'Brien (Hampton, J.) (Entered: 07/27/2015)
8 NOTICE of Appearance by Joel H. Thompson on behalf of Jeffrey Fowler, Emilian Paszko (Thompson, Joel) (Entered: 07/31/2015)
9 Assented to MOTION for Extension of Time to 9/17/2015 to File Answer by Carol Higgins O'Brien.(Hampton, J.) (Entered: 08/06/2015)
10 MEMORANDUM in Support re 9 Assented to MOTION for Extension of Time to 9/17/2015 to File Answer filed by Carol Higgins O'Brien. (Hampton, J.) (Entered: 08/06/2015)
11 Judge Nathaniel M. Gorton: ELECTRONIC ORDER entered granting 9 Motion for Extension of Time to Answer re 1 Complaint, Carol Higgins O'Brien answer due 9/17/2015. (Lima, Christine) (Entered: 08/07/2015)

Case: 1:15-cv-12298-NMG As of: 03/28/2019 04:29 PM EDT 5 of 11

08/07/2015 09/17/2015 09/18/2015
10/02/2015 10/29/2015 10/29/2015
10/30/2015
12/17/2015
12/18/2015 12/18/2015
12/21/2015
03/08/2016 03/10/2016 03/10/2016 03/14/2016 03/14/2016 03/14/2016 03/15/2016 03/15/2016

12 NOTICE of Appearance by Curtis L.S. Carpenter on behalf of Massachusetts Partnership for Correctional Healthcare LLC (Carpenter, Curtis) (Entered: 08/07/2015)
13 ANSWER to 1 Complaint, by Carol Higgins O'Brien.(Benedon, Carrie) (Entered: 09/17/2015)
14 NOTICE of Scheduling Conference Scheduling Conference set for 11/5/2015 03:00 PM in Courtroom 4 before Judge Nathaniel M. Gorton. (Danieli, Chris) (Entered: 09/18/2015)
15 ANSWER to 1 Complaint, with Jury Demand by Massachusetts Partnership for Correctional Healthcare LLC.(Flanagan, William) (Entered: 10/02/2015)
16 Joint MOTION to Continue Scheduling Conference dated 11/5/2015 at 3 p.m. to 1/4/2016 by Carol Higgins O'Brien.(Hampton, J.) (Entered: 10/29/2015)
17 Joint MEMORANDUM in Support re 16 Joint MOTION to Continue Scheduling Conference dated 11/5/2015 at 3 p.m. to 1/4/2016 filed by Carol Higgins O'Brien. (Hampton, J.) (Entered: 10/29/2015)
18 Judge Nathaniel M. Gorton: ELECTRONIC ORDER entered granting 16 Motion to Continue Scheduling Conference set for 1/6/2016 03:30 PM in Courtroom 4 before Judge Nathaniel M. Gorton. (Danieli, Chris) (Entered: 10/30/2015)
19 ELECTRONIC NOTICE OF RESCHEDULING Scheduling Conference set for 1/6/2016 10:45 AM in Courtroom 4 before Judge Nathaniel M. Gorton. NOTE − CHANGE IS AS TO TIME ONLY. (Lima, Christine) (Entered: 12/17/2015)
20 Joint MOTION to Continue Scheduling Conference dated 1/6/16 to 3/7/16 or after by Carol Higgins O'Brien.(Hampton, J.) (Entered: 12/18/2015)
21 MEMORANDUM in Support re 20 Joint MOTION to Continue Scheduling Conference dated 1/6/16 to 3/7/16 or after filed by Carol Higgins O'Brien. (Hampton, J.) (Entered: 12/18/2015)
22 Judge Nathaniel M. Gorton: ELECTRONIC ORDER entered granting 20 Motion to Continue Scheduling Conference set for 3/15/2016 03:00 PM in Courtroom 4 before Judge Nathaniel M. Gorton. (Lima, Christine) (Entered: 12/21/2015)
23 JOINT STATEMENT re scheduling conference set for 3/15/2016. (Hampton, J.) (Entered: 03/08/2016)
24 NOTICE − Parties are reminded to submit their Local Rule 16.1 Certifications forthwith. (Lima, Christine) (Entered: 03/10/2016)
25 CERTIFICATION pursuant to Local Rule 16.1 . (Hampton, J.) (Entered: 03/10/2016)
26 CERTIFICATION pursuant to Local Rule 16.1 of Jeffrey Fowler. (Thompson, Joel) (Entered: 03/14/2016)
27 SUGGESTION OF DEATH Upon the Record as to Emilian Paszko by Emilian Paszko. (Thompson, Joel) (Entered: 03/14/2016)
28 CERTIFICATION pursuant to Local Rule 16.1 . (Carpenter, Curtis) (Entered: 03/14/2016)
29 NOTICE of Appearance by Janna J. Hansen on behalf of Carol Higgins O'Brien (Hansen, Janna) (Entered: 03/15/2016)
30 Electronic Clerk's Notes for proceedings held before Judge Nathaniel M. Gorton: Scheduling Conference held on 3/15/2016: Automatic Discovery to be completed by 4/14/16; Amendments and/or Supplements to the Pleadings, and Motion for Class Certification due by 5/16/2016; opposition to Motion due by 6/16/16. If the case proceeds after class certification, written discovery served by 9/30/16, answered by 10/31/16; all fact Discovery to be completed by 12/31/2016; Plaintiffs' experts designated and Rule 26 Reports exchanged by 2/28/17; Defendants' experts designated and Rule 26 Reports exchanged by 3/31/17; rebuttals by 4/30/17; dispositve Motions due by 7/31/2017, oppositions by 8/31/17, no replies without leave of Court. Joint Status Report regarding Mediation due by 1/15/2017. Final Pretrial Conference set for 11/16/2017 03:00 PM in Courtroom 4 before Judge Nathaniel M. Gorton. Jury Trial

Case: 1:15-cv-12298-NMG As of: 03/28/2019 04:29 PM EDT 6 of 11

04/14/2016 05/16/2016 05/16/2016 05/16/2016 05/16/2016
05/17/2016
05/25/2016 06/13/2016 06/14/2016 06/14/2016 06/30/2016 07/01/2016
07/01/2016 07/14/2016 07/22/2016 07/22/2016 07/22/2016

set for 12/4/2017 09:00 AM in Courtroom 4 before Judge Nathaniel M. Gorton. (Court Reporter: No Court Reporter Used.)(Attorneys present: Shapiro, Kelston, Thompson, Hampton, Hansen, Carpenter) (Lima, Christine) (Entered: 03/16/2016)
31 NOTICE by Carol Higgins O'Brien of Substitution of Thomas Turco for Carol Higgins O'Brien as Commissioner of the Massachusetts Department of Correction (Hampton, J.) (Entered: 04/14/2016)
32 MOTION to Amend 1 Complaint, by Jeffrey Fowler. (Attachments: # 1 Proposed Amended Complaint)(Thompson, Joel) (Entered: 05/16/2016)
33 MEMORANDUM in Support re 32 MOTION to Amend 1 Complaint, filed by Jeffrey Fowler. (Thompson, Joel) (Entered: 05/16/2016)
34 MOTION to Certify Class by Jeffrey Fowler.(Thompson, Joel) (Entered: 05/16/2016)
35 MEMORANDUM in Support re 34 MOTION to Certify Class filed by Jeffrey Fowler. (Attachments: # 1 Exhibit 1, # 2 Exhibit 2, # 3 Exhibit 3, # 4 Exhibit 4, # 5 Exhibit 5, # 6 Exhibit 6, # 7 Exhibit 7, # 8 Exhibit 8, # 9 Exhibit 9, # 10 Exhibit 10, # 11 Exhibit 11, # 12 Exhibit 12, # 13 Exhibit 13, # 14 Exhibit 14, # 15 Exhibit 15, # 16 Exhibit 16, # 17 Exhibit 17, # 18 Exhibit 18, # 19 Exhibit 19, # 20 Exhibit 20, # 21 Exhibit 21, # 22 Exhibit 22)(Thompson, Joel) (Entered: 05/16/2016)
36 ELECTRONIC NOTICE issued requesting courtesy copy for 35 Memorandum in Support of Motion. Counsel who filed this document are requested to submit a courtesy copy of it to the Clerk's Office. These documents must be clearly marked as a Courtesy Copy and reflect the document number assigned by CM/ECF. (Lima, Christine) (Entered: 05/17/2016)
37 NOTICE of Withdrawal of Appearance by J. David Hampton (Hampton, J.) (Main Document 37 replaced on 5/25/2016) (Caruso, Stephanie). (Entered: 05/25/2016)
38 Joint MOTION for Extension of Time to 6/30/2016 to File Response/Reply to Plaintiffs' Motion for Class Certification by Carol Higgins O'Brien.(Hansen, Janna) (Entered: 06/13/2016)
39 Judge Nathaniel M. Gorton: ELECTRONIC ORDER entered granting 38 Motion for Extension of Time to File Response/Reply re 34 MOTION to Certify Class Responses due by 6/30/2016 (Caruso, Stephanie) (Entered: 06/14/2016)
40 NOTICE of Appearance by Thomas Vincent DiGangi on behalf of Thomas Turco (DiGangi, Thomas) (Entered: 06/14/2016)
41 Joint MOTION for Extension of Time to July 14, 2016 to Respond to Plaintiffs' Motion for Class Certification by Massachusetts Partnership for Correctional Healthcare LLC, Thomas Turco.(Hansen, Janna) (Entered: 06/30/2016)
42 Judge Nathaniel M. Gorton: ELECTRONIC ORDER entered granting 41 Motion for Extension of Time to July 14, 2016 to Respond to Plaintiffs' Motion for Class Certification by Massachusetts Partnership for Correctional Healthcare LLC, Thomas Turco. (Caruso, Stephanie) (Entered: 07/01/2016)
43 Set/Reset Deadlines as to 34 MOTION to Certify Class . Responses due by 7/14/2016 (Caruso, Stephanie) (Entered: 07/01/2016)
44 Joint RESPONSE to Motion re 34 MOTION to Certify Class filed by Thomas Turco. (Hansen, Janna) (Entered: 07/14/2016)
45 Judge Nathaniel M. Gorton: ENDORSED ORDER entered granting 32 Motion to Amend 1 Complaint, by Jeffrey Fowler. (Caruso, Stephanie) (Entered: 07/25/2016)
46 Judge Nathaniel M. Gorton: ENDORSED ORDER entered granting 34 Motion to Certify Class (Caruso, Stephanie) (Entered: 07/25/2016)
47 Judge Nathaniel M. Gorton: ENDORSED ORDER entered. re 44 Joint RESPONSE to Motion re 34 MOTION to Certify Class filed by Thomas Turco.
"Joint Class Certification Proposal in approved."

Case: 1:15-cv-12298-NMG As of: 03/28/2019 04:29 PM EDT 7 of 11

07/26/2016 07/29/2016 08/12/2016 08/12/2016 10/25/2016 11/10/2016 11/10/2016 12/08/2016 12/29/2016 01/11/2017
01/17/2017 01/18/2017 04/19/2017 04/27/2017

(Caruso, Stephanie) (Entered: 07/25/2016)
48 Judge Nathaniel M. Gorton: ELECTRONIC ORDER entered. Plaintiffs are directed to file their amended complaint re 45 Order on Motion to Amend (Caruso, Stephanie) (Entered: 07/26/2016)
49 AMENDED COMPLAINT against Massachusetts Partnership for Correctional Healthcare LLC, Thomas Turco, filed by Jeffrey Fowler, Paul R. Whooten, Michael Turner, Michael Fitzpatrick.(Thompson, Joel) (Entered: 07/29/2016)
50 ANSWER to 49 Amended Complaint by Massachusetts Partnership for Correctional Healthcare LLC.(Carpenter, Curtis) (Entered: 08/12/2016)
51 ANSWER to 49 Amended Complaint by Thomas Turco.(Benedon, Carrie) (Entered: 08/12/2016)
52 Joint MOTION for Protective Order by Thomas Turco. (Attachments: # 1 Text of Proposed Order Proposed Stipulated Protective Order)(Hansen, Janna) (Attachment 1 replaced on 10/26/2016) (Lima, Christine). (Entered: 10/25/2016)
53 Judge Nathaniel M. Gorton: ENDORSED ORDER entered granting 52 Motion for Protective Order. "Joint motion allowed subject to the provision on page 16 of the order." (Caruso, Stephanie) (Entered: 11/14/2016)
54 Judge Nathaniel M. Gorton: ORDER entered. PROTECTIVE ORDER. "Subject, specifically, to the provisions of Local Rule 7.2."(Caruso, Stephanie) (Entered: 11/14/2016)
55 NOTICE of Appearance by Anne M. McLaughlin on behalf of Thomas Turco (McLaughlin, Anne) (Entered: 12/08/2016)
56 Joint MOTION for Extension of Time to 5/1/2017 to Complete Discovery by Michael Fitzpatrick, Jeffrey Fowler, Michael Turner, Paul R. Whooten.(Thompson, Joel) Modified on 1/18/2017 (Caruso, Stephanie). (Entered: 12/29/2016)
57 Judge Nathaniel M. Gorton: ENDORSED ORDER entered. "Motion allowed"
re 56 Joint MOTION for Extension of Time to 5/1/2017 to Complete Discovery filed by Jeffrey Fowler, Paul R. Whooten, Michael Fitzpatrick, Michael Turner
Completion of fact discovery, including responses to writtenDiscovery to be completed by 5/1/2017; Plaintiffs experts designated and Rule 26 reports produced by 6/30/2017; Defendants experts designated and Rule 26 reports produced by 7/31/2017; Expert rebuttals produced by 8/31/2017; Dispositive motions due by 10/2/2017; Oppositions to dispositive motions due by 11/2/2017; Joint Status Report regarding mediation due by 1/17/2017; Final Pretrial Conference set for 1/16/2018 03:00 PM in Courtroom 4 before Judge Nathaniel M. Gorton; Jury Trial set for 2/5/2018 09:00 AM in Courtroom 4 before Judge Nathaniel M. Gorton. (Caruso, Stephanie) (Entered: 01/12/2017)
58 JOINT STATEMENT of counsel on Mediation. (Thompson, Joel) (Entered: 01/17/2017)
59 NOTICE of Withdrawal of Appearance by Thomas Vincent DiGangi (DiGangi, Thomas) (Entered: 01/18/2017)
60 Joint MOTION for Extension of Time to July 31, 2017 to Complete fact discovery by Thomas Turco.(Benedon, Carrie) Modified on 4/27/2017 (Caruso, Stephanie). (Entered: 04/19/2017)
61 Judge Nathaniel M. Gorton: ENDORSED ORDER entered granting in part and denying in part 60 Motion for Extension of Time to Complete Discovery
"Joint motion allowed, in part, and denied, in part; the extended deadlines are approved as requested except that the jury trial, if necessary will commence on Mon., April 30, 2018 at 9:00 A.M.. There will be no further extensions of time." (Caruso, Stephanie) (Entered: 04/27/2017)

Case: 1:15-cv-12298-NMG As of: 03/28/2019 04:29 PM EDT 8 of 11

04/27/2017
04/28/2017 07/10/2017 07/10/2017 07/11/2017 07/18/2017 07/19/2017 07/25/2017
07/25/2017

62 Set/Reset Scheduling Order Deadlines: Completion of fact discovery, including responses to written Discovery to be completed by 7/31/2017; Plaintiffs experts designated and Rule 26 reports produced by 9/28/2017; Defendants experts designated and Rule 26 reports produced by 10/30/2017; Expert rebuttals produced by 11/29/2017; Dispositive motions due by 1/5/2018; Oppositions to dispositive motions due by 2/6/2018; Final Pretrial Conference set for 4/23/2018 03:00 PM in Courtroom 4 before Judge Nathaniel M. Gorton; Jury Trial set for 4/30/2018 09:00 AM in Courtroom 4 before Judge Nathaniel M. Gorton (Caruso, Stephanie) Modified on 4/28/2017 (Caruso, Stephanie). (Entered: 04/27/2017)
63 Notice of correction to docket made by Court staff. Correction: Docket Entry 62 corrected because: Status Report deadline of 1/17/17 has been satisfied and removed from the deadlines. (Caruso, Stephanie) (Entered: 04/28/2017)
64 MOTION to Compel Production of Documents and to Extend Discovery Deadline by Michael Fitzpatrick, Jeffrey Fowler, Michael Turner, Paul R. Whooten.(Thompson, Joel) (Entered: 07/10/2017)
65 MEMORANDUM in Support re 64 MOTION to Compel Production of Documents and to Extend Discovery Deadline filed by Michael Fitzpatrick, Jeffrey Fowler, Michael Turner, Paul R. Whooten. (Attachments: # 1 Exhibit)(Thompson, Joel) (Entered: 07/10/2017)
66 Judge Nathaniel M. Gorton: ELECTRONIC ORDER entered. REFERRING CASE to Magistrate Judge Donald L. Cabell Referred for: Events Only (e). Motions referred: 64 MOTION to Compel Production of Documents and to Extend Discovery Deadline. (Caruso, Stephanie) Motions referred to Donald L. Cabell. (Entered: 07/11/2017)
67 ELECTRONIC NOTICE of Hearing. Telephone Conference re: 64 MOTION to Compel Production of Documents and to Extend Discovery Deadline set for 7/24/2017 10:30 AM in Courtroom 23 before Magistrate Judge Donald L. Cabell. Participating counsel should call into 888−278−0296; Access Code: 6533617 at least 5 minutes before the hearing. (Russo, Noreen) (Entered: 07/18/2017)
68 ELECTRONIC NOTICE OF RESCHEDULING: Telephone Conference re: 64 MOTION to Compel Production of Documents and to Extend Discovery Deadline reset for 7/25/2017 at 03:00 PM in Courtroom 23 before Magistrate Judge Donald L. Cabell. Participating counsel should call into 888−278−0296; Access Code: 6533617 at least 5 minutes before the hearing. (Russo, Noreen) (Entered: 07/19/2017)
69 Electronic Clerk's Notes for proceedings held before Magistrate Judge Donald L. Cabell: Telephone Conference held on 7/25/2017. The parties contacted the court re 64 and indicated that a telephone conference may be helpful to resolve the motion. After hearing from the parties: MPCH will make efforts to comply and produce documents within thirty days. Any third party discovery will have to be sought by Rule 17 subpoenas or otherwise sought with those third parties. The parties believe that all discovery including depositions can be completed by the end of September and the court will extend the discovery deadline to September 30, 2017. In light of this plan counsel indicates the motion is moot. (Court Reporter: Digital Recording.) To order a copy of this Digital Recording, please go to http://www.mad.uscourts.gov/attorneys/Magistrate−Audio.htm . For a transcript of this proceeding, contact Deborah Scalfani by email at deborah_scalfani@mad.uscourts.gov.(Attorneys present: Carpenter, Thompson, Benedon, Hansen)(Russo, Noreen) (Entered: 07/25/2017)
70 Magistrate Judge Donald L. Cabell: ELECTRONIC ORDER entered denying as moot 64 Motion to Compel. The plaintiff's motion to compel production of documents is denied as moot. As agreed during the telephone court hearing on this day, the defendant Massachusetts Partnership for Correctional Healthcare shall make every effort to produce the requested materials within 30 days of this order. With respect to any materials that may be in the possession of third parties, the plaintiff understands that the materials will need to be sought directly from those entities. To effect the foregoing and allow the parties sufficient time to review and make use of the materials, discovery will be extended incorporate the materials. The discovery deadline is further extended to the end of September, 2017. (Russo, Noreen) (Entered: 07/25/2017)

Case: 1:15-cv-12298-NMG As of: 03/28/2019 04:29 PM EDT 9 of 11

07/25/2017 10/06/2017 10/12/2017
10/18/2017 10/20/2017 11/21/2017 11/22/2017
11/29/2017 12/06/2017 12/08/2017
12/23/2017 01/31/2018 02/01/2018 02/01/2018

71 Case no longer referred to Magistrate Judge Donald L. Cabell. (Russo, Noreen) (Entered: 07/25/2017)
72 ELECTRONIC NOTICE of Hearing. Telephone Conference re docket no. 69 set for 10/12/2017 03:00 PM in Courtroom 23 before Magistrate Judge Donald L. Cabell. Counsel may participate by phone and should call into 888−278−0296; Access Code: 6533617 at least 5 minutes before the hearing.(Russo, Noreen) (Entered: 10/06/2017)
73 Electronic Clerk's Notes for proceedings held before Magistrate Judge Donald L. Cabell: Telephone Conference held on 10/12/2017. The court convened the hearing upon request of Att. Thompson indicating there has been some delay with regard to discovery. Counsel for MPCH indicate that the production is a complicated process which has taken more time than expected but they are working diligently and expect to have it completed by 10/20 − having previously been expected by August 31. As a result, the scheduling deadlines are getting tight and may need to be extended a bit. Magistrate Judge Cabell asks the parties to confer and to file a motion directed to Judge Gorton concerning the requested scheduling issues. (Court Reporter: Digital Recording.) To order a copy of this Digital Recording, please go to http://www.mad.uscourts.gov/attorneys/Magistrate−Audio.htm . For a transcript of this proceeding, contact Deborah Scalfani by email at deborah_scalfani@mad.uscourts.gov.(Attorneys present: Thompson (by phone), Flanagan and Carpenter (in person), Hansen (by phone)) (Russo, Noreen) (Entered: 10/12/2017)
74 NOTICE of Appearance by Timothy D. Hartnett on behalf of Thomas Turco (Hartnett, Timothy) (Entered: 10/18/2017)
75 Joint MOTION to Continue Trial, Joint MOTION to Amend Scheduling Order Deadlines ( Responses due by 11/3/2017) by Massachusetts Partnership for Correctional Healthcare LLC.(Carpenter, Curtis) (Entered: 10/20/2017)
76 Judge Nathaniel M. Gorton: ENDORSED ORDER entered granting 75 Motion to Extend Deadlines and Continue Trial. Bench Trial set for 5/21/2018 09:00 AM in Courtroom 4 before Judge Nathaniel M. Gorton. (Lima, Christine) (Entered: 11/22/2017)
77 Set/Reset Deadlines: Document production completed by 10/20/17; fact Discovery to be completed by 12/8/2017; Plaintiffs' experts disclosed and Rule 26 Reports exchanged by 12/22/17; Defendants' experts disclosed and Rule 26 Reports exchanged by 1/19/18; rebuttal expert reports exchanged by 2/2/18; dispositive Motions due by 2/16/2018, oppositions due by 3/16/18. Rule 26 Meeting Report due by 1/19/2018.(Lima, Christine) (Entered: 11/22/2017)
78 ELECTRONIC NOTICE OF RESCHEDULING Final Pretrial Conference set for 5/9/2018 03:00 PM in Courtroom 4 before Judge Nathaniel M. Gorton. (Lima, Christine) (Entered: 11/29/2017)
79 Joint MOTION to Stay by Michael Fitzpatrick, Jeffrey Fowler, Michael Turner, Paul R. Whooten.(Thompson, Joel) (Entered: 12/06/2017)
80 Judge Nathaniel M. Gorton: ENDORSED ORDER entered granting 79 Motion to Stay. "Motion allowed with the caveat that if the case is not reported settled on or before January 31, 2018, all previously set deadlines will be continued for 90 days and the final pretrial conference will be held on Thursday, August 9, 2018 at 3:00 PM." (Lima, Christine) (Entered: 12/11/2017)
81 STATUS REPORT by Michael Fitzpatrick, Jeffrey Fowler, Michael Turner, Paul R. Whooten. (Thompson, Joel) (Entered: 12/23/2017)
82 STATUS REPORT (Joint) by Michael Fitzpatrick, Jeffrey Fowler, Michael Turner, Paul R. Whooten. (Thompson, Joel) (Entered: 01/31/2018)
83 Judge Nathaniel M. Gorton: ELECTRONIC ORDER entered. Parties are directed to file a status report by February 10, 2018. (Franklin, Yvonne) (Entered: 02/01/2018)
84 Set/Reset Deadlines: Status Report due by 2/10/2018 (Lima, Christine) (Entered: 02/01/2018)

Case: 1:15-cv-12298-NMG As of: 03/28/2019 04:29 PM EDT 10 of 11

02/09/2018 02/09/2018 02/09/2018 02/12/2018 02/15/2018 03/09/2018
03/09/2018
03/12/2018
03/15/2018 03/20/2018
04/06/2018 04/06/2018 04/06/2018 04/09/2018 04/16/2018 04/16/2018 04/19/2018 04/19/2018 04/20/2018 04/23/2018 05/21/2018

85 Letter/request for public records (non−motion) from Steven Morello. (Franklin, Yvonne) (Entered: 02/09/2018)
86 NOTICE of Withdrawal of Appearance by Curtis L.S. Carpenter (Carpenter, Curtis) (Entered: 02/09/2018)
87 STATUS REPORT CONCERNING SETTLEMENT by Michael Fitzpatrick, Jeffrey Fowler, Michael Turner, Paul R. Whooten. (Thompson, Joel) (Entered: 02/09/2018)
88 Set/Reset Deadlines: Status Report due by 3/12/2018 (Lima, Christine) (Entered: 02/12/2018)
89 NOTICE of Appearance by Tory A. Weigand on behalf of Massachusetts Partnership for Correctional Healthcare LLC (Weigand, Tory) (Entered: 02/15/2018)
90 Joint MOTION for Settlement Approval by Michael Fitzpatrick, Jeffrey Fowler, Michael Turner, Paul R. Whooten. (Attachments: # 1 Settlement Agreement, # 2 HCV Clinical Guidance, # 3 Proposed Notice to Class)(Thompson, Joel) (Entered: 03/09/2018)
91 MEMORANDUM in Support re 90 Joint MOTION for Settlement Approval filed by Michael Fitzpatrick, Jeffrey Fowler, Michael Turner, Paul R. Whooten. (Attachments: # 1 Affidavit of Joel H. Thompson)(Thompson, Joel) (Entered: 03/09/2018)
92 ELECTRONIC NOTICE issued requesting courtesy copy for 91 Memorandum in Support of Motion, 90 Joint MOTION for Settlement Approval. Counsel who filed these documents are requested to submit a courtesy copy of them to the Clerk's Office. These documents must be clearly marked as a Courtesy Copy and reflect the document number assigned by CM/ECF. (Lima, Christine) (Entered: 03/12/2018)
93 NOTICE:Courtesy copy received 3/15/18 Re: D.E. #90 & #91. (Franklin, Yvonne) (Entered: 03/16/2018)
94 Judge Nathaniel M. Gorton: ELECTRONIC ENDORSED ORDER entered Joint Motion Allowed 90 Motion for Settlement. (Franklin, Yvonne) (Paine, Matthew). (Entered: 03/20/2018)
95 Letter/request (non−motion) from Arthur Saccoach regarding Class Action Suit. (Franklin, Yvonne) (Entered: 04/06/2018)
96 Letter/request (non−motion) Opposing the Proposed Class Action Suit from Thomas Young. (Franklin, Yvonne) (Entered: 04/06/2018)
97 Letter/request(non/motion) Objection to Class Action Suit from Marcos Soto. (Franklin, Yvonne) (Entered: 04/06/2018)
98 Letter/request (non−motion) from Schuyler Gibson. Request to become a class member. (Franklin, Yvonne) (Entered: 04/09/2018)
99 Objection to the Proposed Class Action Suit, from Ramadan Shabazz. (Lima, Christine) (Entered: 04/17/2018)
100 Objection to the Proposed Class Action Suit, filed by MacArthur Denson. (Lima, Christine) (Entered: 04/17/2018)
101 Objection to Proposed Settlement, filed by Ramadan Shabazz. (Lima, Christine) (Entered: 04/20/2018)
102 Objections to Proposed Settlement, filed by Antonio Gomes. (Attachments: # 1 Exhibit)(Lima, Christine) (Entered: 04/20/2018)
104 Objection to Proposed Class Settlement, filed by Ernesto Ortiz. (Lima, Christine) (Entered: 04/25/2018)
103 Objection to Proposed settlement, filed by Harold A. Maxwell. (Franklin, Yvonne) (Entered: 04/24/2018)
105 Assented to MOTION to Dismiss Voluntarily Plaintiff Michael Fitzpatrick by Jeffrey Fowler, Michael Turner, Paul R. Whooten.(Thompson, Joel) (Entered: 05/21/2018)

Case: 1:15-cv-12298-NMG As of: 03/28/2019 04:29 PM EDT 11 of 11

05/22/2018 05/22/2018 06/13/2018 06/21/2018 06/21/2018 06/22/2018 06/28/2018
06/29/2018
07/06/2018 07/11/2018 03/22/2019 03/22/2019 03/22/2019 03/22/2019 03/22/2019 03/25/2019

106 ELECTRONIC NOTICE of Hearing.Final Approval Hearing set for 6/28/2018 02:30 PM in Courtroom 4 before Judge Nathaniel M. Gorton. (Lima, Christine) (Entered: 05/22/2018)
107 Judge Nathaniel M. Gorton: ELECTRONIC ORDER entered ALLOWED 105 Motion to Dismiss plaintiff Michael Fitzpatrick. (Franklin, Yvonne) (Entered: 05/22/2018)
108 Judge Nathaniel M. Gorton: ELECTRONIC ORDER entered. Responses to settlement objections must be filed on or before 6/21/18. (Lima, Christine) (Entered: 06/13/2018)
109 RESPONSE TO COURT ORDER by Thomas Turco and Plaintiffs. (Hansen, Janna) (Entered: 06/21/2018)
110 Joint MOTION to Seal Document by Thomas Turco.(Hansen, Janna) (Entered: 06/21/2018)
111 Judge Nathaniel M. Gorton: ELECTRONIC ORDER entered ALLOWING 110 Motion to Seal Document. (Franklin, Yvonne) (Entered: 06/22/2018)
113 Electronic Clerk's Notes for proceedings held before Judge Nathaniel M. Gorton: Final Approval Hearing held on 6/28/2018. Court hears from the parties with regards to the joint settlement proposal. MPCH will be dismissed without prejudice if the proposal is approved. Court finds that the settlement is fair, reasonable, and adequate, and approves the class settlement and settlement agreement. Court will review the matter of fees promptly. Defendants have an agreement in place with regards to how they plan to pay the fees. (Court Reporter: Debra Lajoie at lajoiedebra@gmail.com.)(Attorneys present: Shapiro, Thompson, Benedon, Hansen, Weigand) (Lima, Christine) Modified on 6/29/2018 (Lima, Christine). (Entered: 06/29/2018)
114 Judge Nathaniel M. Gorton: ELECTRONIC ORDER entered re 90 Joint MOTION for Settlement Approval filed by Jeffrey Fowler, Paul R. Whooten, Michael Fitzpatrick, Michael Turner. "Pursuant to Fed. R. Civ. P. 23(e), the Settlement Agreement (Docket No. 90) is, with respect to attorneys fees and costs, approved. Class Counsel is awarded $270,000 for attorneys fees and $1,500 for expenses." (Lima, Christine) (Entered: 06/29/2018)
115 NOTICE of Appearance by J. David Hampton on behalf of Thomas Turco (Hampton, J.) (Entered: 07/06/2018)
116 NOTICE of Withdrawal of Appearance by Janna J. Hansen (Hansen, Janna) (Entered: 07/11/2018)
117 NOTICE of Appearance by Stephen G. Dietrick on behalf of Thomas Turco (Dietrick, Stephen) (Entered: 03/22/2019)
118 NOTICE of Withdrawal of Appearance by J. David Hampton (Hampton, J.) (Entered: 03/22/2019)
119 NOTICE of Withdrawal of Appearance by Timothy D. Hartnett (Hartnett, Timothy) (Entered: 03/22/2019)
120 NOTICE of Withdrawal of Appearance by Carrie M. Benedon (Benedon, Carrie) (Entered: 03/22/2019)
121 NOTICE of Appearance by Tatum A. Pritchard on behalf of Jeffrey Fowler, Michael Turner, Paul R. Whooten (Pritchard, Tatum) (Entered: 03/22/2019)
122 NOTICE of Withdrawal of Appearance by Anne M. McLaughlin (McLaughlin, Anne) (Entered: 03/25/2019)

 
 CCaassee11:1:155-c-cvv-1-122229988-N-NMMGG DDooccuummeennt t3429-1 FFileiledd0075/2/196/1/166 PPaaggee11oof f1188

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

JEFFREY FOWLER, PAUL WHOOTEN, MICHAEL TURNER, and MICHAEL FITZPATRICK, on behalf of themselves and all others similarly situated,
Plaintiffs,
v.
THOMAS TURCO, Commissioner of Massachusetts Department of Correction, in his official capacity, and MASSACHUSETTS PARTNERSHIP FOR CORRECTIONAL HEALTHCARE, LLC,
Defendants.

C.A. NO. 1:15CV12298

FIRST AMENDED CLASS ACTION COMPLAINT Introduction
1. This is a class action that seeks declaratory and injunctive relief under 42 U.S.C. §1983 for violation of the Eighth Amendment as a result of the deliberate indifference of defendants, the Commissioner of the Massachusetts Department of Correction and the Massachusetts Partnership for Correctional Healthcare, LLC (“MPCH”), to the serious medical needs of plaintiffs and the members of the class, who are infected with the Hepatitis C virus. Over 1,500 state prisoners in Massachusetts have Hepatitis C, but as of the present time very few of them have been treated for it. For many of them, including plaintiffs and the members of their class, the illness will progress toward end stage liver disease and death. A major advance in treatment was made in 2014, with the introduction of medication regimens that have nearperfect success rates, far fewer side effects, and a much shorter duration. Despite these

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advances, defendants have failed and refused to provide this new treatment to plaintiffs and the members of their class.
The DOC and MPCH have instead continued a years-long reduction in the number of patients treated for Hepatitis C; they have knowingly delayed evaluating prisoners, and they have consciously avoided knowledge of their treatment needs. Prisoners who ought to receive the new medications are not receiving them, and a vast number of prisoners with Hepatitis C are not even being afforded the necessary testing to determine the severity of their disease.
Plaintiffs Jeffrey Fowler, Paul Whooten, Michael Turner, and Michael Fitzpatrick are four such prisoners. They bring this action on behalf of themselves and all other state prisoners with Hepatitis C to remedy defendants’ deliberate indifference to their serious medical need for treatment for their Hepatitis C. By not assuming the financial cost of Hepatitis C treatment, defendants are imposing a human cost on the prisoners in their care as well as on the population which will be at risk when these prisoners are released.
JURISDICTION AND VENUE 2. The Court has subject matter jurisdiction over plaintiffs’ claims pursuant to 28 U.S.C. §§1331 (federal question jurisdiction) and 1343 (civil rights jurisdiction). 3. Venue is proper pursuant to 28 U.S.C. §1391(b).
PARTIES 4. Plaintiff Jeffrey Fowler is currently incarcerated at Old Colony Correctional Center in Bridgewater, Massachusetts, a penal institution operated by the DOC. Mr. Fowler has Hepatitis C and, without treatment, he will suffer from the complications of this disease, up to and including death. He brings this action on his own behalf and on behalf of all prisoners in DOC custody who have Hepatitis C.
2

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5. Non-invasive testing has confirmed that Mr. Fowler has advanced liver fibrosis (scarring). In 2014, Mr. Fowler was treated with triple therapy, a medication regimen that preceded today’s medication regimens, but that treatment was unsuccessful. Since then, he has waited in vain to be treated with the Interferon-free regimens that have been available for two and a half years.
6. Plaintiff Paul Whooten is currently incarcerated at Souza-Baranowski Correctional Center in Lancaster, Massachusetts. Mr. Whooten has Hepatitis C and, without treatment, he will suffer from the complications of this disease, up to and including death. He brings this action on his own behalf and on behalf of all prisoners in DOC custody who have Hepatitis C.
7. Mr. Whooten was treated for Hepatitis C before his incarceration, but the treatment failed. A subsequent 2011 liver biopsy revealed moderate fibrosis. Since entering DOC custody, Mr. Whooten has repeatedly sought treatment but has been denied.
8. Plaintiff Michael Turner is currently incarcerated at NCCI-Gardner in Gardner, Massachusetts. Mr. Turner has Hepatitis C and, without treatment, he will suffer from the complications of this disease, up to and including death. He brings this action on his own behalf and on behalf of all prisoners in DOC custody who have Hepatitis C.
9. Mr. Turner was treated with combination therapy in 2012, while incarcerated, but it was discontinued because it was not working and Mr. Turner suffered from significant side effects. Since the arrival of Interferon-free regimens in late 2014, Mr. Turner has sought treatment but has been denied. MPCH deems him a low priority for treatment. A January 2016 blood test indicated that he has severe fibrosis.
10. Plaintiff Michael Fitzpatrick is currently incarcerated at MCI-Norfolk in Norfolk, Massachusetts. Mr. Fitzpatrick has Hepatitis C and, without treatment, he will suffer from the
3

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complications of this disease, up to and including death. He brings this action on his own behalf and on behalf of all prisoners in DOC custody who have Hepatitis C.
11. Mr. Fitzpatrick was treated with triple therapy in 2013, while in DOC custody, but had to stop treatment because of severe side effects. Mr. Fitzpatrick has cirrhosis of the liver, and he has developed esophageal varices and GAVE disease. He has required repeated hospitalizations in the three years since stopping treatment, and he has sought treatment with Interferon-free regimens but has been denied.
12. Defendant Thomas Turco is the Commissioner of the Massachusetts DOC, and he is being sued in his official capacity. The DOC is an agency of the Commonwealth of Massachusetts that is charged with the care and custody of state prisoners and has a constitutional obligation to attend to the serious medical needs of the prisoners in its custody. Defendant Turco is aware of the facts alleged below, and he has acted, and continues to act, under color of law, custom and policy with respect to his failure and refusal to provide constitutionally adequate care and treatment to plaintiffs and the members of their class.
13. Defendant Massachusetts Partnership for Correctional HealthCare, LLC (“MPCH”) is a Massachusetts corporate entity with a principal place of business in Westborough, Massachusetts. MPCH is the health care provider for the DOC, pursuant to a contract between the two parties. Since July 1, 2013, MPCH has been responsible for providing adequate medical care to all prisoners in DOC custody. MPCH is aware of the facts alleged in this Complaint, and has been acting, and continues to act, under color of law, custom and policy with respect to its failure and refusal to provide constitutionally adequate medical care and treatment to plaintiffs and the members of their class.
4

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CLASS ACTION ALLEGATIONS 14. This is a class action under Rule 23(a) and (b) of the Federal Rules of Civil Procedure. 15. Plaintiffs are representatives of a class composed of all prisoners in the custody of the DOC who have Hepatitis C. 16. Membership in the class is so numerous that joinder of all members is impracticable. Over 1,500 DOC prisoners have Hepatitis C at any given time, and the population changes as persons are admitted and released. 17. Plaintiffs’ claims involve common questions of law and fact that are typical of the claims of the class as a whole. The claims concern defendants’ policy and practice for treating Hepatitis C, which is applicable to all prisoners with Hepatitis C. Common questions include (1) whether treatment for Hepatitis C is a serious medical need; (2) whether defendants have knowingly failed to provide the necessary staging of Hepatitis C patients in accordance with the prevailing standard of care, including the pretreatment testing to determine the severity of the disease; (3) whether defendants have knowingly failed to provide treatment for plaintiffs and the members of their class with the newest, most effective medications for Hepatitis C in accordance with the prevailing standard of care; (4) whether defendants have knowingly employed policies and practices that unjustifiably delay or deny treatment for Hepatitis C; (5) whether defendants have permitted cost considerations to improperly interfere with the treatment of Hepatitis C; (6) whether defendants’ failure to provide treatment to plaintiffs and the member of their class in accordance with the prevailing standard of care for treatment of Hepatitis C has put plaintiffs and the members of their class at risk of serious harm; and (7) whether defendants have been deliberately indifferent to the serious medical needs of plaintiffs
5

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and the members of their class. 18. These common questions predominate over any questions affecting only individual
class members. Defendants have acted and refused to act on grounds generally applicable to the class so that final declaratory and injunctive relief would be appropriate to the class as a whole.
19. Plaintiffs have a strong personal interest in the outcome of this litigation, and they are represented by competent counsel who will adequately and fairly protect the interests of the class.
20. A class action is superior to any other available method for a fair and efficient adjudication of this controversy. Separate actions by individual members of the class would create a risk of inconsistent or differing adjudications and delay the ultimate resolution of the issues at stake.
FACTS Hepatitis C Defined 21. Hepatitis C is a blood borne disease caused by the Hepatitis C virus (“HCV”). The virus brings about inflammation that damages liver cells. It is a leading cause of liver disease and liver transplants. 22. There are several different genotypes of Hepatitis C, with subtypes. Genotype 1 is the most common type of Hepatitis C in the United States. 23. Approximately eighty percent of people who become infected with the Hepatitis C virus will develop chronic Hepatitis C. 24. Chronic Hepatitis C patients develop fibrosis (liver scarring), which can worsen liver function until the patient develops cirrhosis. Ultimately, patients may end up with end stage liver disease, cancer, or other serious illnesses. Some patients will need a liver transplant,
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and others will die. 25. Hepatitis C is transmitted by infected blood. Methods of transmission include
intravenous drug use (via shared equipment), tattooing (same), blood transfusions (with infected blood, largely before regular screening of donated blood began), and sex. Intravenous drug use is the most common means of transmission in the U.S.
26. It is widely accepted that the number of reported cases of Hepatitis C nationwide understates its actual prevalence. In 2000, the United States Surgeon General called Hepatitis C a “silent epidemic,” and estimated that as much as two percent of the adult U.S. population had Hepatitis C.
27. The last decade has seen a spike in reported cases of Hepatitis C among young people. This increase in new cases of Hepatitis C is largely attributable to the increase in opioid addiction and the resulting use of intravenous drugs.
28. The incidence of Hepatitis C is not diminishing, and its effects are worsening. In 2011, the CDC reported that Hepatitis C had overtaken HIV as a cause of death.
Hepatitis C in Prison 29. The prevalence of Hepatitis C in prison is higher than in the general population. It is estimated to be anywhere from 9.6% to 41.1% of the prison population nationally. As many as half a million people in prison at any given time have Hepatitis C. 30. In 1997, according to one study, 29% to 43% of all people infected with Hepatitis C in the United States passed through a correctional facility. 31. In the Massachusetts Department of Correction, over 1,500 of the ten thousand prisoners are known to have Hepatitis C.
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History of Hepatitis C Treatment 32. Treatment exists for chronic Hepatitis C. The available treatments have changed over time. 33. In 1991, a drug called Interferon was approved to be used alone. Seven years later, the FDA approved the use of Ribavirin alongside Interferon, and in 2001, Ribavirin was paired with Pegylated Interferon. This regimen was referred to as combination therapy. 34. Combination therapy was marked by a long duration of treatment – 48 weeks. The medications had significant side effects. Interferon in particular was troublesome, causing such side effects as depression, thrombocytopenia, and loss of bone marrow. While research had shown that combination therapy was very effective against Genotypes 2 and 3, only around 60% of patients with Genotype 1 taking combination therapy achieved a Sustained Viral Response (“SVR”) – an undetectable viral load six months after completing treatment, which is considered a cure. 35. The standard of care after 2001 was to treat Genotypes 2 or 3 with combination therapy, and to treat Genotype 1 with combination therapy if the patient had reached a certain stage of liver damage, typically measured by a liver biopsy. If after treatment the virus was not suppressed, or if it was suppressed during treatment but later returned, there was no other treatment available for the so-called nonresponder or relapser. 36. 2011 saw the FDA approval of two protease inhibitors that produced better results when either one was taken with combination therapy, especially for Genotype 1 (SVR of 6080%). 37. The standard of care evolved to include so-called triple therapy – one of the two protease inhibitors, taken with Interferon and Ribavirin – for Genotype 1 patients. Triple
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therapy was effective on nonresponders and relapsers, giving them a new option and potential cure.
38. The duration of treatment with triple therapy remained the same as with combination therapy, as did the side effects. The expense increased because of the additional medication.
39. In 2013 and 2014, the FDA approved more new antiviral medications. These medications can now be taken as part of an Interferon-free regimen. The change is dramatic; the worst side effects are avoided. The regimen is a much shorter duration – 12 weeks for most. Best of all, the success rate for these regimens is better than combination or triple therapy – well over 90%, including for nonresponders and relapsers.
40. There have also been changes in how the disease is monitored. To measure fibrosis, providers now generally forego a liver biopsy in favor of non-invasive tests. Blood tests can offer an accurate assessment of liver fibrosis, and these tests can be coupled with certain types of scanning if desired.
41. These new developments in staging the disease, and treating it, have eliminated the barriers to a cure.
History of Hepatitis C Treatment in the DOC 42. The DOC has treated some prisoners for Hepatitis C since approximately 2000, with combination therapy the treatment of choice since 2002. 43. In about 2002, the DOC implemented a Hepatitis C treatment protocol, with input from its health care contractor and the Department of Public Health. 44. The treatment protocol contained directions for screening of prisoners. Those prisoners considered at high risk would be given an HCV antibody test (detecting whether HCV
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antibodies are present in the blood). 45. If a prisoner tested positive for HCV antibodies, confirmatory testing would be
done, including liver function tests and measurement of the viral load (the amount of virus in the blood).
46. Laboratory testing and a medical assessment would be done to determine whether the prisoner should receive a liver biopsy. A biopsy provided the best evidence of whether there was fibrosis of the liver.
47. If the biopsy resulted in a recommendation for treatment, the prisoner did not necessarily receive treatment right away. He or she was instead placed on a wait list. The DOC and its health care contractor rationed treatment, authorizing a certain number of “treatment slots” – a maximum number of prisoners who could receive treatment at one time. Prisoners were selected from the wait list for treatment based on the severity of their disease, and other factors.
48. The DOC and its health care contractor paid close attention to the number of prisoners receiving combination therapy and to how much money had been spent on Pegylated Interferon and Ribavirin. Monthly reports calculated both numbers.
49. The DOC’s health care contractor had a Hepatitis C program manager – a staff member dedicated to overseeing Hepatitis C treatment in the DOC. The manager followed the number of Hepatitis C cases, managed a database of Hepatitis C prisoners, maintained the wait list, and participated in the determination of who received treatment and when.
50. The treatment protocol contained several exclusions, some of which were tied to prison issues rather than medical issues. For example, prisoners who were too close to their release date would not receive treatment, the stated concern being that the prisoner would not
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complete the treatment after release. Moreover, prisoners who received certain types of disciplinary reports would be rendered ineligible for treatment.
51. By 2011, when triple therapy arrived nationally, the DOC and its health care contractor had been convening a Hepatitis C Task Force for two years. The Task Force was comprised of representatives from the DOC, its health care contractor, and the Department of Public Health.
52. The Task Force and its members were well aware of the two new protease inhibitors before their approval by the FDA. Nevertheless, the treatment protocol was not amended in a timely way when triple therapy became available.
53. A sizable number of prisoners in the DOC were nonresponders or relapsers. These patients in particular had had little hope of cure, until the arrival of triple therapy. Most or all of them had not been staged (evaluated) in a long time, and did not know how much farther their liver fibrosis had progressed.
54. New prisoners were also entering DOC custody with Hepatitis C, specifically with Genotype 1, for which triple therapy was superior to combination therapy.
55. Many of these prisoners sought staging and a determination of their eligibility for treatment. Prisoner advocates inquired about how the DOC and its health care contractor planned to implement triple therapy, and especially how it planned to conduct the necessary testing for nonresponders and relapsers – patients who needed to be brought back into the treatment pipeline.
56. For nearly two years, prisoners and their advocates were told only that the treatment protocol was “under review.” Heavy emphasis was placed on the fact that the medications were “new,” even though their arrival had been anticipated for years, and even as months passed
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without a single DOC prisoner receiving triple therapy. 57. In July of 2012, the DOC advised that its task force continued to meet, that its health
care contractor was still working on a revised protocol, and that after the protocol was submitted, the DOC would then review it further. There was no timetable for implementation of the new protocol.
58. On October 3, 2012, the DOC issued a Request for Response – a call for bids on a new health care contract. In its Request, the DOC advised that it was still “in the process of implementing a new Hepatitis C protocol.”
59. Finally, in 2013, a few DOC prisoners began to receive triple therapy. Very few prisoners were treated.
60. The DOC has for years reduced Hepatitis C treatment, as has MPCH since its arrival in 2013 as DOC’s health care contractor. In Fiscal Year 2009 (July 2008 – June 2009), an average of 81 prisoners were taking Hepatitis C medications in any given month. In Fiscal Year 2014, that number had dropped to 16.
61. This dramatic reduction in the number of treatment slots was coupled with a failure to stage Hepatitis C patients. With nonresponders and relapsers joining the treatment-naïve Hepatitis C patients, the situation called for a rigorous, speedy process of conducting the necessary tests. This task should have been made easier since the standard of care permitted non-invasive tests, rather than liver biopsies, to measure liver fibrosis. But such a process never emerged.
62. In late 2013, the FDA approved Sovaldi and Olysio, which brought an even higher cure rate for Genotype 1 when taken with Interferon and Ribavirin, or when taken together without Interferon or Ribavirin.
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63. Within their joint Pharmacy & Therapeutics Committee, defendants first discussed Sovaldi in April of 2014. In the months leading up to that meeting, defendants had further reduced the number of prisoners on triple therapy or combination therapy.
64. By the time of the August 2014 Pharmacy & Therapeutics Committee meeting, defendants reported having an interim guideline for use of Sovaldi, and three prisoners were said to have been evaluated and cleared to begin therapy that month.
65. However, at the September 2014 meeting, it was reported that in all DOC facilities there were only six prisoners taking combination therapy, six prisoners taking triple therapy, and no prisoners taking Sovaldi. The three prisoners referred to above were now said to be ready for treatment “once operational processes are put into place.”
66. By October of 2014, there were only five prisoners cleared to start treatment with Sovaldi “once operational processes are put into place.” Meanwhile, the number of prisoners receiving combination or triple therapy dropped to six.
67. The FDA approved Harvoni (in October 2014) and Viekira Pak (in December 2014), both of which are Interferon-free treatment regimens. These regimens also enjoy nearperfect cure rates.
68. Nevertheless, only a handful of prisoners have been treated with one of the new regimens. As of February 2015, there were only three prisoners taking Hepatitis C medications of any kind. Defendants have not changed their policy or practice to recognize the new reality in Hepatitis C treatment, and they have done nothing to ensure timely pre-treatment testing of the many prisoners – the nonresponders, relapsers, and treatment-naïve – who will benefit from treatment now.
69. Moreover, defendants have not addressed their protocol’s outdated treatment
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exclusions. For example, disqualifying prisoners based on an upcoming release date made some sense under a 48-week combination therapy regimen, but today the standard treatment time is 12 weeks. Prisoners with decompensated cirrhosis of the liver used to be excluded, but the new regimens are effective in these cases. Excluding prisoners who have contraindications to taking Interferon or Ribavirin is no longer necessary or appropriate.
Conscious Disregard of Serious Needs by Delay and Denial 70. In years past using combination therapy, the DOC rationed treatment, delaying care for many prisoners. However, they at least treated eighty or more Hepatitis C prisoners at a time. The DOC provided combination therapy despite its challenges, which included a long duration of treatment, significant side effects (some of which would require abandoning treatment, and some of which could only be treated at further expense), only a moderate chance of success (for Genotype 1), and high-priced medications. 71. Today, the standard of care is to use Interferon-free regimens. These regimens are of much shorter duration, lack the worst side effects, and offer a near-certain cure. Defendants, however, have treated almost no one with the newest regimens. 72. Systemic delay – delay in the defendants’ approval of the new medications, delay in amendments to the treatment protocol, delay in the timely staging of prisoners, and delay in treatment itself – rewards Defendants, who thereby delay or avoid paying for treatment. 73. In the case of prisoners who are released without having been treated, who will require treatment for the Hepatitis C and also the complications therefrom, such delay amounts to patient-dumping on the hospitals and medical providers who will inherit these patients. 74. When prisoners inquire about Hepatitis C treatment, defendants respond vaguely. They indicate that the prisoner will have a chronic disease appointment soon, that the Hepatitis
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C protocol is under review, or that the prisoner is on a list, without any specific commitment about if or when the prisoner will be treated.
75. There is no legitimate excuse for delaying treatment. Defendants knew that the Interferon-free regimens were coming long before they were approved by the FDA.
76. In fact, defendants counseled prisoners out of combination or triple therapy by pointing to the imminent arrival of Interferon-free regimens. They saved money by deferring treatment and reducing the number of treatment slots, in anticipation of this time.
77. The DOC and its health care contractor knew before 2011, when triple therapy arrived, that they needed to bring a large number of prisoners who were previously ineligible for treatment – particularly nonresponders and relapsers – back into the treatment protocol, by ordering pre-treatment tests and staging them. They failed to do so then, and defendants are failing to do so now.
78. Defendants’ now-outdated treatment protocol contemplated a staging process of twelve months. It is taking far longer than that to work up most prisoners, with some not being ordered the necessary tests or consults at all, despite the staging process being easier and less invasive than ever before.
79. The result of this foot-dragging is that defendants do not know which prisoners need treatment the most. By their actions, defendants have made a conscious choice not to know.
80. Moreover, to treat only the most severe cases of Hepatitis C is no longer the standard of care. The standard of care now is to treat any patient with chronic Hepatitis C. In the past, prisoners without advanced fibrosis were encouraged to wait for the arrival of new regimens. Those regimens are now here and have been here for two and a half years.
81. Having chosen to delay treatment for so many prisoners from 2011 to 2016, and
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having saved a significant amount of money in so doing, defendants cannot now be heard to complain about cost, or to delay treatment any longer under the guise of further deliberation.
82. Defendants should be adhering to specific guidelines and short deadlines for followup testing and evaluation of prisoners who, for whatever reason, were previously deemed ineligible for treatment.
Risk of Serious Harm That Results 83. Some 20% of people with Hepatitis C will progress toward cirrhosis, putting them at risk of end stage liver disease, cancer, and death. Many people with Hepatitis C develop pain, fatigue, and other ailments as well. 84. DOC prisoners with Hepatitis C are at risk of serious harm, including cirrhosis, end stage liver disease, cancer, and death, if they do not receive timely and adequate testing and treatment. 85. The risk of serious harm and death is not hypothetical. Other prisoners were forced to wait while their untreated Hepatitis C led to their deaths.
CLAIM FOR RELIEF CRUEL AND UNUSUAL PUNISHMENT IN VIOLATION OF THE EIGHTH AND
FOURTEENTH AMENDMENTS TO THE UNITED STATES CONSTITUTION 86. Plaintiffs restate and reallege paragraphs 1-85 as if fully set forth herein. 87. In all relevant aspects, defendants have acted, and are acting, under color of law,
custom and policy. 88. By their policies, practices, and acts, defendants are violating the rights of plaintiffs
and the members of their class to be free from cruel and unusual punishment guaranteed by the Eighth and Fourteenth Amendments to the United States Constitution and 42 U.S.C. § 1983 as a result of their deliberate indifference to the serious medical needs of plaintiffs and the members
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of their class for immediate and effective treatment for Hepatitis C. PRAYER FOR RELIEF
89. WHEREFORE, plaintiffs request that this Court grant them the following relief: a. Certify that this action be maintained as a class action of all prisoners in Department of Correction custody who have Hepatitis C; b. Issue a judgment against defendants, declaring that their acts, omissions, policies, and practices with regard to the treatment of Hepatitis C are cruel and unusual punishment in violation of the Eighth and Fourteenth Amendments to the United States Constitution and 42 U.S.C. § 1983; c. Issue preliminary and permanent injunctions ordering defendants to implement and adhere to a comprehensive treatment protocol that includes timely and adequate screening of DOC prisoners; timely evaluation and staging of Hepatitis C prisoners; timely treatment with the most effective medications; timely and adequate treatment of side effects to ensure that the Hepatitis C treatment is successful; and elimination of unjustified exclusions from or denials of treatment; d. Enjoin defendants from taking any action to interfere with plaintiffs’ right to maintain this action, or from retaliating in any way against plaintiffs for bringing this action; e. Award plaintiffs their reasonable attorneys’ fees and costs, in accordance with 42 U.S.C. § 1988 and other applicable law;
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f. Grant such other and further relief as this Court considers just and proper.

Date: May 16, 2016

Respectfully submitted,
Plaintiffs Jeffrey Fowler, Paul Whooten, Michael Turner, and Michael Fitzpatrick, on behalf of themselves and all others similarly situated,
By their attorneys,
/s/ Jonathan Shapiro Jonathan Shapiro, BBO #454220 jshapiro@swglegal.com David Kelston, BBO #267310 dkelston@swglegal.com Shapiro Weissberg & Garin 90 Canal Street Boston, MA 02114 (617) 742-5800, ext. 115
Cooperating Attorneys National Lawyers Guild Massachusetts Chapter, Inc.
/s/ Joel H. Thompson Joel H. Thompson, BBO #662164 jthompson@plsma.org Prisoners’ Legal Services 10 Winthrop Square, 3rd Flr. Boston, MA 02110 (617) 482-2773, ext. 102

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 Case 1:15-cv-12298-NMG Document 90-1 Filed 03/09/18 Page 1 of 15

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

JEFFREY FOWLER, PAUL WHOOTEN, MICHAEL TURNER, and MICHAEL FITZPATRICK on behalf of themselves and all others similarly situated.
Plaintiffs,

THOMAS TURCO, Commissioner of Massachusetts Department of Correction, in his official capacity, and MASSACHUSETTS PARTNERSHIP FOR CORRECTIONAL HEALTHCARE, INC.,
Defendants.

C.A.NO. 1:15CV12298­NMG

SETTLEMENT AGREEMENT

I. PARTIES AND DEFINITIONS

1. The Parties to this Settlement Agreement ("Agreement") are plaintiffs Jeffrey

Fowler, Paul Whooten, and Michael Turner'; the Class Members; and defendant Thomas Turco,

in his official capacity as Commissioner of the Massachusetts Department of Correction.

Defendant Massachusetts Partnership for Correctional Healthcare is not a party to this

Agreement.

2. "Action" shall refer to the above­captioned action.

3. "Amended Complaint" shall refer to the Amended Complaint filed in the Action

on or about July 29, 2016.

4.

"Class Counsel" shall refer to Joel Thompson of Prisoners' Legal Services and

1 Michael Fitzpatrick, identified in the case as a class representative, is no longer in the custody of the Department of Correction and thus is not a member of the class. Counsel will file an appropriate motion removing him as a class representative.
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Jonathan Shapiro and David Kelston of Shapiro, Weissberg & Garin.

5.

"Class Members" shall refer to all current and future DOC prisoners who have or

will have Hepatitis C, as defined by the Court in its order allowing class certification.

6. "Contractor" shall refer to the entity providing correctional healthcare to DOC

prisoners.

7.

"DAA" shall refer to the class of medications known as Direct­Acting Antivirals,

used to treat the Hepatitis C virus.

8.

"DOC" shall refer to the Massachusetts Department of Correction, as established

by G.L. c. 27.

9. "DOC Commissioner" shall refer to the Commissioner of the Massachusetts

Department of Correction, as defined in G.L. c. 27, § 1.

10. "Fairness Hearing" shall refer to the hearing before the Court where the Parties will request that this Agreement be entered as an Order of the Court, as fair, reasonable, and

adequate, and approve the Fee Award.

11. "Fee Award" shall refer to the amount of attorneys' fees and reimbursement of expenses and costs awarded by the Court to Class Counsel.
12. "Final Approval" shall refer to this Court's entry of this Agreement as an Order of

the Court following the Fairness Hearing. 13. "Monitor" shall refer to the consultant(s) hired by DOC to ensure compliance
with the Protocol, including any subsequent consultant(s), which DOC selects. 14. "MPCH" shall refer to the Massachusetts Partnership for Correctional
Healthcare, one of the defendants in the Action.

15. "Notice" shall refer to the notice to the Class Members of this Agreement. 16. "Patient" shall refer to any prisoner in the custody of DOC who has Hepatitis C.

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17. "Plaintiffs" shall refer to the individuals named as plaintiffs in the Action, and Class Members.
18. "Preliminary Court Approval" shall refer to the Court's preliminary approval of this Agreement and the Notice.
19. "Prisoner" shall refer to a committed offender and such other person as is placed in custody in a state correctional facility in accordance with law, as defined in G.L. c. 125, § l(m), or an Inmate as defined in G.L. c. 125, § l(i).
20. "Protocol" shall refer to the document titled "Clinical Guidance: Evaluation and Management of Chronic Hepatitis C Virus (HCV) Infection," as amended from time to time in accordance with the provisions of this Agreement. A current version of the Protocol, dated February 2018, is appended hereto as Exhibit A, the provisions of which are incorporated herein by reference.
II. Focus OF THIS AGREEMENT
21. The Parties acknowledge and agree that this Agreement is intended to address the medical treatment of Prisoners who have Hepatitis C.
III. IMPLEMENTATION OFHEPATITIS C TREATMENT PROTOCOL 22. Immediately following execution of this Agreement and Preliminary Approval by
the Court and for the term of this Agreement, DOC shall cause the Contractor to implement the Protocol.
23. As of the date of Preliminary Approval of this Agreement by the Court, DOC shall cause the Contractor to produce a list of all Patients, and DOC shall produce a copy of the list to Class Counsel.
24. As detailed at pages 12­14 of the Protocol, DOC shall cause the Contractor to assign all Patients a Priority Level of 1, 2a, 2b, 2c, or 3, based on the criteria stated therein, and in
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accordance with the screening and testing procedures set forth in the Protocol. 25. Within 12 months of the date of Preliminary Approval of this Agreement by the
Court, DOC shall cause the Contractor to treat all Priority Level I Patients identified pursuant to paragraph 24 of this Agreement with DAAs, in accordance with the terms of the Protocol, regardless of how long it takes for the Contractor to assign them to this Priority Level.
26. Within 18 months of the date of Preliminary Approval of this Agreement by the Court, DOC shall cause the Contractor to treat all Priority Level 2a, 2b, and 2c Patients identified pursuant to paragraph 24 of this Agreement with DAAs, in accordance with the terms of the Protocol, regardless of how long it takes for the Contractor to assign them to this Priority Level.
27. During the 18 months following the date of Preliminary Approval of this Agreement by the Court, DOC shall cause the Contractor to treat any newly­admitted Prisoner who has the Hepatitis C virus and who is assigned a Priority Level of 1, 2a, 2b, or 2c, with DAAs, in accordance with the terms of the Protocol and in the following timeframes:
• Level 1 within 9 months of being assigned to Level 1; and, • Levels 2a, 2b, and 2c within 12 months of being assigned to Level 2a, 2b, or 2c. 28. Within 18 months of the date of Preliminary Approval of this Agreement by the Court, DOC shall cause the Contractor to treat any existing Patient who had been assigned a Priority Level of 3, but who subsequently is re­assigned a Priority Level of 1, 2a, 2b, or 2c, with DAAs, in accordance with the terms of the Protocol and in the following timeframes: • Level 1 within 9 months of being assigned to Level 1; and, • Levels 2a, 2b, and 2c within 12 months of being assigned to Level 2a, 2b, or 2c. 29. Notwithstanding any other provision in this Agreement, after the initial 18­month period following Preliminary Approval of this Agreement by the Court, DOC shall cause the Contractor to treat any Prisoner who has the Hepatitis C virus and who is assigned a Priority Level of 1 with DA As, in accordance with the terms of the Protocol, within 3 months of being assigned
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or reassigned to Level 1. 30. Notwithstanding any other provision in this Agreement, after the initial 18­month
period following Preliminary Approval of this Agreement by the Court, DOC shall cause the Contractor to treat any Prisoner who has the Hepatitis C virus and who is assigned a Priority Level of 2a or 2b with DAAs, in accordance with the terms of the Protocol, within 6 months of being assigned or reassigned to Level 2a or 2b.
31. Notwithstanding any other provision in this Agreement, after the initial 18­month period following Preliminary Approval of this Agreement by the Court, DOC shall cause the Contractor to treat any Prisoner who has the Hepatitis C virus and who is assigned a Priority Level of 2c with DAAs, in accordance with the terms of the Protocol, within 12 months of being assigned or reassigned to Level 2c.
32. The schedule laid out above is based on the review and analysis of current Patient information provided by DOC's Contractor and on national benchmarking data. DOC estimates that approximately 280 Patients in the current Prisoner population fall into Priority Levels 1, 2a, 2b, or 2c. If actual clinical experience demonstrates a 30% higher number of patients categorized as Priority Level 1, 2a, 2b or 2c than expected, the schedule shall be subject to revision. In this event, DOC shall notify Class Counsel in writing of the higher than expected Patient identification numbers and Class Counsel and DOC shall negotiate in good faith on a revised schedule. In any event:
• the schedule laid out in paragraph 25 shall not extend beyond 12 months from the date of Preliminary Approval of this Agreement by the Court;
• the schedule laid out in paragraph 26 shall not extend beyond 30 months from the date of Preliminary Approval of this Agreement by the Court.
33. In the event that changes in medical practice or the operational needs of DOC and/or the Contractor require revisions to the Protocol, DOC agrees to provide written notice of the
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proposed changes to Class Counsel. Class Counsel shall have 30 days to comment on the proposed changes, which DOC shall consider in good faith, and any disputes between DOC and Class Counsel shall be resolved pursuant to Section VII of this Agreement. Any changes to the Protocol shall not extend the schedule for treatment outlined above or materially reduce the treatment provided.
IV. MONITORING FOR COMPLIANCE WITH THE PROTOCOL AND AGREEMENT 34. Within 60 days of Final Approval, DOC shall enter into an agreement with a
Monitor, who shall not be DOC's medical contractor or any person employed by DOC, and who shall be reasonably acceptable to Class Counsel, whose role will be to ensure proper adoption and implementation of the Protocol. DOC shall provide a copy of the agreement with the Monitor to Class Counsel.
35. The Monitor shall conduct a concurrent review of a random selection of 100 identified Patients within the first 180 days of implementation of the Protocol, as set forth in paragraph 23 of this Agreement, from the screening and testing phase through the treatment and post­treatment monitoring, for such period of time as the Patient remains in DOC custody.
36. In addition to its concurrent review, the Monitor shall, at 6­month intervals starting upon DOC's entering into an agreement with the Monitor as set forth in paragraph 34 of this Agreement, conduct a retrospective review of Protocol adherence, from patient screening and baseline testing through post­treatment monitoring. The retrospective review shall include an audit of at least 10% of all Patient medical records, to ensure appropriate testing and staging in accordance with the Protocol.
37. The Monitor shall provide 6­month reports to the Parties on the results of its reviews. The Monitor, Class Counsel, Plaintiffs, and the Contractor shall use these reports only in connection with this litigation and for no purpose other than determining adherence to the Agreement and the agreed­upon Protocol. These reports shall not be disseminated other than to
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Class Counsel, DOC, and the Contractor and cannot be introduced in any proceeding other than in this Action and then only for the purpose of demonstrating material compliance or material non­ compliance with the adoption and implementation of the Protocol.
38. The Monitor's monitoring functions under this Agreement shall continue for a period of 30 months from the date of Final Approval of this Agreement by the Court.
39. The Monitor shall have access to all Prisoner medical records for the limited purpose of conducting its concurrent and retrospective reviews as detailed above. DOC shall cause the Contractor to cooperate with the Monitor and to provide access to all needed Prisoner medical records. All Parties shall comply with all applicable state and federal laws and requirements governing confidentiality of medical records, and shall negotiate in good faith to enter into any agreements required to protect said confidentiality of Prisoner medical records.
40. DOC's agreement with the Monitor shall provide that if the Monitor believes that there has been material non­compliance with the adoption and implementation of the Protocol, the Monitor shall raise that issue promptly with DOC and with Class Counsel and shall identify, in writing, the specific provision for which the Monitor believes there has been material non­ compliance. The purpose of doing so will be to give the Parties a reasonable opportunity to review, discuss and correct any such material non­compliance. DOC shall provide the Monitor and Class Counsel with a written response within thirty (30) days. Any further dispute resolution required in response to findings by the Monitor shall be subject to the Dispute Resolution provisions of Section VII of this Agreement.
41. In addition to the Monitor's review for compliance with the Protocol, DOC shall, at 3­month intervals, generate and provide to Class Counsel reports sufficient to determine compliance with the treatment schedule set forth in paragraphs 25 to 31 of this Agreement. Such reports shall include, at a minimum, a list of all Patients, along with each Patient's assigned Priority Level, the date each Patient was assigned that Priority Level, the date each Patient entered DOC custody, and
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the date each Patient began treatment with DAAs, if at all. If Class Counsel believes there has been material non­compliance with the treatment schedule set forth in paragraphs 25 to 31 of this Agreement, Class Counsel shall notify DOC in writing of the specific provision for which the Monitor believes there has been material non­compliance. DOC shall provide Class Counsel with a written response within thirty (30) days. Any further dispute resolution shall be subject to the Dispute Resolution provisions of Section VII of this Agreement. V. PRELIMINARY APPROVAL
42. As soon as practicable following execution of this Agreement, DOC shall provide Class Counsel with the names and addresses of all Class Members, in the form of the "HCV Summary" provided by MPCH, and the Parties shall apply to the Court for a preliminary order:
a) granting Preliminary Approval of this Agreement for purposes of disseminating notice to current DOC prisoners who are Class Members; b) approving the form, contents, and dissemination of the Notice of this Agreement to current DOC prisoners who are Class Members in the form and pursuant to the method attached hereto as Exhibit B; c) scheduling a Fairness Hearing to review comments and/or objections regarding this Agreement, consider the fairness, reasonableness, and adequacy of this Agreement, and consider whether the Court should order Final Approval of this Agreement and grant Class Counsel's requested Fee Award. VI. THE FEE AWARD 43. Class Counsel may file an application with the Court for payment by DOC of the Fee Award, to include (i) their reasonable attorneys' fees in an amount not to exceed $270,000.00, and (ii) their costs and expenses incurred in prosecution of this Action not to exceed $1,500.00. DOC agrees not to object to, and DOC agrees to pay such Fee Award if limited to those amounts. Notwithstanding anything herein, the Parties agree that the Court's failure to approve, in whole or
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in part, the Fee Award sought by Class Counsel shall not prevent this Agreement from becoming effective nor be grounds for termination of this Agreement. Class counsel reserve all rights to seek reasonable attorneys' fees and costs for successful enforcement of this Agreement after Final Approval, and DOC reserves all rights to oppose any such petition for fees and costs. VII. FINAL APPROVAL, DISPUTE RESOLUTION, AND ENFORCEMENT
44. All Parties agree that this Agreement represents a full and fair resolution of the claims for relief alleged in the Amended Complaint concerning the medical treatment of Prisoners who have Hepatitis C.
45. For purposes of this Agreement and its Final Approval by the Court, the Parties agree that this Action shall be maintained as a class action under FED. R. CIV. P. 23 with the class defined as all current and future DOC prisoners who have or will have Hepatitis C. The Parties also agree that the named plaintiffs, with the exception of Michael Fitzpatrick, or any person substituted for a named plaintiff by the Parties, shall be the class representatives for the Class Members.
46. This Agreement shall be subject to the Final Approval of the Court. The Parties shall cooperate in presenting this Agreement to the Court for Final Approval and/or at any hearing under FED. R. Crv. P. 23(e). If the Court grants Final Approval, the Parties stipulate that this Agreement shall not be construed as a consent decree. If the Court does not grant Final Approval, this Agreement shall be null and void and of no force and effect, and nothing herein shall be deemed to prejudice the position of any Party with respect to the Action or otherwise, and neither the existence of this Agreement, nor any of its terms or provisions, nor any of the negotiations or proceedings connected with it, shall be admissible in evidence, referred to for any purpose in the Action or in any other litigation or proceeding, or construed as an admission, presumption, or concession by any Defendant of any liability or the truth of any of the allegations in the Action.
47. This Agreement may be enforced only by the Parties hereto. Nothing contained in this Agreement is intended or shall be construed to evidence an intention to confer any rights or
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remedies upon any person other than the Parties hereto. 48. If Plaintiffs believe that there has been material non­compliance with any provision
of this Agreement by DOC, Plaintiffs, through Class Counsel, shall provide counsel of record for DOC, in writing, the specific reasons and grounds for such belief, including an identification of the specific provision with which such Plaintiff or Class Member believes there was material non­ compliance. DOC shall have 30 days to respond to Plaintiffs' written statement. The Parties agree that any minor, incidental, or isolated breach or delay in implementation of a provision of this Agreement shall not constitute material non­compliance.
49. If the alleged material non­compliance is not resolved by or in connection with DOC's response to Plaintiffs' written statement. Plaintiffs, through Class Counsel, and DOC may jointly or individually seek relief from the Court to effect material compliance with this Agreement.
50. If the Court determines that there has been material non­compliance by DOC with a provision of this Agreement at any time during the period of the Agreement, the Court may enter an order consistent with equitable principles that is designed to achieve material compliance with such provision(s) of this Agreement, but not through a petition for contempt.
51. If Plaintiffs, through Class Counsel, contend that DOC has not complied with an order entered by the Court under the preceding paragraph. Plaintiffs may, after reasonable notice to DOC, move for further relief from the Court to obtain compliance with the Court's prior order. In ruling on such motion, the Court may apply equitable principles and may use any appropriate equitable or remedial power available to it.
52. The term of this Agreement shall commence upon the date of Final Approval by the Court and shall extend for 30 months from said date of Final Approval. The Court's jurisdiction shall terminate at the end of the 30­month period with respect to any provision of this Agreement for which there is no pending claim that DOC is in material non­compliance. If the Court
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determines that there has been material non­compliance by DOC with a provision of this Agreement at any time during the 30­month period of this Agreement, or if there is a pending claim at the end of the 30­month period, the Court's jurisdiction with respect to such provision or provisions relating thereto shall continue until such time as DOC is found by the Court to be in compliance with this Agreement.
53. The Court shall be the sole forum for the enforcement of this Agreement. The Parties agree not to seek termination of or otherwise challenge this Agreement or any order approving this Agreement during the period of time that the Court retains jurisdiction. Nothing in this paragraph shall limit the Parties' rights to challenge or appeal any finding or any order entered by the Court.
54. Subject to the provisions set forth in this Section, this Agreement shall expire at the end of 30 months from the date of Final Approval by the Court and the Action shall be dismissed with prejudice. VIII. DISMISSAL OF MPCH FROM ACTION
55. Plaintiffs agree to dismiss MPCH from this Action, with prejudice, upon Final Approval of this Agreement. IX. APPROPRIATIONS AND RECEIPT OF FUNDING
56. The Parties acknowledge that DOC's ability to fulfill its obligations under this Agreement is subject to appropriations by the Legislature.
57. In order to implement and comply with this Agreement, the DOC shall submit budget requests as needed and will, consistent with Article 63 of the Massachusetts Constitution, make its best efforts to obtain the funding necessary to implement and comply with this Agreement. In the event that DOC alleges that it is unable to fulfill its obligations under this Agreement because of no or inadequate appropriations by the Legislature, Class Counsel reserve all rights to seek additional relief from the Court, including orders to the Commonwealth's executive or
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legislative branch and DOC reserves all rights to respond and/or oppose any such requested additional relief.
X. No ADMISSION OF LIABILITY
58. Nothing in this Agreement shall be construed in any way as an admission by DOC of any liability or wrongdoing whatsoever. DOC specifically disclaims any liability or wrongdoing whatsoever on the part of itself, its agents, and employees. XL MISCELLANEOUS
59. This Agreement sets forth the entire agreement between the Parties hereto, and fully supersedes any and all prior agreements or understandings between the Parties hereto pertaining to the subject matter hereof.
60. This Agreement shall be deemed to be made and entered into in the Commonwealth of Massachusetts and shall in all respects be interpreted, enforced, and governed under the laws of said Commonwealth and the laws of the United States.
61. This Agreement may not be relied upon as precedent in any future claim and shall not in any way be construed as an admission, presumption, or concession by any Defendant of any liability or wrongdoing whatsoever.
62. Each Party represents and acknowledges that each Party is and has been represented by its own counsel. Each Party further represents and acknowledges that, in executing this Agreement, no Party relies or has relied upon any representations or statements made by any other Party or its counsel other than the promises and representations set forth in this Agreement.
63. Should any part, term, or provision of this Agreement be declared or be determined by any Court to be illegal or invalid, the validity of the remaining parts, terms, or provisions shall not be affected thereby and said illegal or invalid part, term, or provision shall be deemed not to be a part of this Agreement, unless the Court declines to approve this Agreement.
64. Except as otherwise stated, this Agreement shall only be amended, revoked,
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changed, or modified through a written agreement executed by ail the Parties and approved by the Court. No waiver of any provision of this Agreement will be valid unless it is in writing and signed by the Party against whom such waiver is charged and approved by the Court.
65. This Agreement is the result of an arm's­length negotiation. Since all Parties contributed substantially, materially, and cooperatively in drafting this Agreement, it shall not be more strictly construed against one Party than any other.
66. This Agreement may be executed in a number of identical counterparts, all of which shall together constitute one Agreement, and such execution may be evidenced by signatures delivered by facsimile transmission or other electronic means.

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T H O M A S T T T R r n TTT R' n m m i s e i n n p r n f the Massachusetts Department of Correction,
(
Janna J. Hansen, BBO # 662063 Carrie Benedon, BBO # 625058 Assistant Attorneys General Government Bureau One Ashburton Place Boston, MA 02108 (617) 963­2812 (Hansen) (617) 963­2080 (Benedon) Janna.Hansen@state.ma.us Carrie.Benedon@state.ma.us
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