Clinical trial NCT03801707
Conditions: Kidney Transplant Hepatitis C HCV
Sponsor: Ohio State University
Start date: 2019-03-22; Completion date: 2021-04-30
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the safety and feasibility of transplanting kidneys from Hepatitis C virus (HCV) infected donors into recipients without HCV infection

Detailed description:
This will be an open label, prospective, interventional, proof of concept study to evaluate the feasibility and safety of kidney transplant from HCV positive donors into HCV negative recipients using treatment with pan-genotypic direct acting antiviral therapies (DAAS) for treatment of post-transplant HCV transmission

Arms: arm 1: kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.
Interventions: intervention 1: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] intervention 2: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET]
Intervention descriptions: intervention 1: fixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C intervention 2: Three tablets once a day for 12 weeks for treatment of hepatitis C

Protocol documents:
Prot_SAP_ICF_001.pdf: 
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Version: 6.0 
Study Protocol, Statistical Analysis Plan, and Informed Consent for  
Utilization of Hepatitis C Positive Kidneys in Negative Recipients  
(USE-Hep C) 
I. 
Objectives 
To evaluate the safety and feasibility of transplanting kidneys from Hepatitis C virus (HCV) 
infected donors into recipients without HCV infection  
 
II. 
Background and Rationale  
a. Background 
 
Patients with end stage renal disease (ESRD) have increased mortality compared to their 
healthy peers with a five years survival chance of 42-52% in hemodialysis and peritoneal 
dialysis patients respectively. Over the last decade, the number of ESRD patients has risen 
significantly. In 2015, there was over 124,000 new cases and 703,243 prevalent cases of 
ESRD in the United States (1a). Kidney transplantation remains the preferred treatment 
modality. Successful kidney transplantation is associated with improved survival, improved 
quality of life and health care cost savings when compared to dialysis. However, the gap 
between patients in needs and available organs remains large. In 2017, there were over 
94,000 patients waiting on the deceased donor kidney transplant waiting list with only 
28,588 deceased donor transplantation performed(1). This organ shortage along with the 
advances in the available treatments of transmittable diseases such as human 
immunodeficiency virus (HIV) and hepatitis C virus (HCV) has prompted the transplant 
society to explore donors previously believed to be an acceptable candidate for donation.  
 
Traditionally, HCV donor positive (HCV D+) kidneys were offered only to HCV positive 
recipients due to a 100% HCV transmission risk. Due to the low numbers of kidney 
transplant candidates who are also HCV positive, many of these kidneys are discarded. 
The development of direct acting anti-viral drugs (DAAs) have transformed the realm of HCV 
therapy. DAAs has turned HCV hepatitis into a highly curable condition with cure rates 
exceeding 95% for all different HCV genotypes 1 through 6(2-6).  
 
DAAs can be safely used in all solid organ transplantation. Sofosbuvir/velpastasvir (Epclusa) 
combination was used for treatment of recurrent HCV infection (genotype 1 through 6) after 
liver transplantation (3, 5, 7). A 12 weeks treatment resulted in overall 96% cure rate in 
patients with and without cirrhosis. The drug combination was very well tolerated and had 
minimal interaction with immunosuppressants. Once daily Glecaprevir/pibrentasvir 
(Mavyret) combination was used to treat HCV infection (genotype 1 through 6) in 80 liver 
transplant and 20 kidney transplant recipients in the MAGELLAN-2 study(8). The overall cure 
rate was 98% at 12 weeks post-treatment. The drug combination was again very well 
tolerated.  


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These advances in the treatment of HCV infection has made it possible to entrain the use of 
organs from HCV viremic patients into non infected HCV recipients with plan for HCV 
treatment post transplantation  
 
b. Rationale: 
DAAs are highly tolerated by patients and carry a cure rate of >95%. This favorable side 
effect profile and high efficacy can help expand the pool of available organs by increasing 
the utilization of organs from HCV infected donors. Over the past decade, the opioid crisis 
have increased the number of HCV infected deceased donors. These donors are usually 
young with fewer comorbid conditions such as diabetes and hypertension. Organ procured 
from such donors are usually of good quality. The transmission rate of HCV when using 
infected organ is guaranteed but the availability of DAAs make this less of a concern. This 
scenario has been tested and proven safe by other groups. The EXPANDER (Exploring Renal 
Transplant Using Hepatitis C Infected Donors for HCV- Negative Recipients) group at Johns 
Hopkins University performed transplantation of kidneys from HCV+ into 10 HCV- 
recipients(9). The group used elbasvir-grzoprevir (supplemented with sofosbuvir for 
genotype 2, 3) started before transplant and continued for 12 weeks post-transplant. There 
were no treatment related adverse effects. HCV virus was undetectable with stable liver 
function in all recipients 12 weeks after completion of treatment.  
Another group, the THINKER (Transplanting Hepatitis C kidneys Into Negative Kidney 
Recipient), from the University of Pennsylvania also used similar drug combination elbasvir-
grazoprevir (Zepatier)  in 20 HCV negative recipients who received kidneys from donor 
infected with HCV genotype -1(10). The group reported a 100% transmission rate of HCV 
with 100% cure rate as evident by undetectable HCV pcr in the blood 12 weeks post 
treatment. There were again no treatment related adverse events. Kidney allograft function 
was excellent at 6 and 12 months. 
  
The use of HCV + donors into negative recipients has also been investigated in thoracic 
organ transplantation including heart (11) and lung (12, 13). Patients in these reports were 
treated by either Sofosbuvir/Ledipasvir (Harvoni) if they contacted HCV genotype 1 or 
Sofosbuvir/Velpatasvir if they contracted other genotypes. All of the reported cases had 
complete cure of HCV transmitted after transplant and no treatment associated adverse 
effects.  
 
Giving the large body of evidence supporting the safety and efficacy of DAAs in treatment of 
HCV in the transplant recipients, we at the Ohio State University, would also like to explore 
the safety of transplanting HCV positive kidneys into negative recipients in our program. We 
hope to incorporate this a standard practice for patients who consent to receive HCV + 
donor kidney. 
 
We plan on using Sofosbuvir/Velpatasvir (Epclusa) as our first therapy choice. Our choice for 
Epclusa stems from the fact it’s a daily one tablet preparation (improving patient’s 
treatment adherence), has minimal drug-drug interaction with immunosuppressive drugs, 


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and is equally effective again all different HCV genotypes without needs for supplemental 
therapy. Epclusa has been studied in liver transplant patients and proven to be effective and 
very well tolerated (7). The one important caveat with Epclusa is its need for dose 
adjustment in renal failure. Hence, we plan on using Glecaprevir/Pibrentasvir (Mavyret) as 
agent of choice in patients who develop delayed graft function or continue to have poor 
allograft function with estimated glomerular filtration rate (eGFR) <30 ml/min by one to two 
weeks post-transplant. Mavyret does not require dose adjustment based on renal function 
and is equally effective against all different HCV genotypes.  It was also studied in liver and 
kidney transplant patients and proven highly effective and well tolerated (8). 
Sofosbuvir/Velpatasvir or elbasvir/grazoprevir will be used as a third-line drug based on the 
HCV genotype in case of coverage denial of the first and second-line drugs by the patient’s 
health insurance. 
 
c. Significance:  
DAAs has the potential to turn HCV infection into a condition similar to cytomegalovirus 
(CMV) infection. Currently, it’s a routine and completely acceptable practice to transplant 
organs from CMV+ donors to CMV- recipients. These recipients are at very high risk for CMV 
infection. In the absence of preventive measures, 40 to 100% off all kidney transplant 
patients will develop CMV infection and up to 67% will develop CMV disease that could be 
life threatening(14, 15). Such risk is greatly ameliorated by the presence of active treatment 
for CMV infection in the form of ganciclovir, cidofovir and foscarnet. Similarly, DAAs are 
effective and very well tolerated treatment that should make transplanting HCV positive 
organs into negative donors possible.  
 
It is hard to accurately estimate the number of additional donors that could be available if 
HCV+ organs are being used routinely. It’s estimated that between 2005 and 2014 about 
4,144 kidneys from HCV+ donors were discarded(16). Many more kidneys from HCV infected 
donors were probably never procured because of fear of lack of appropriate recipients. Over 
8000 lives could have been saved have these kidneys been utilized. Additionally, accepting 
kidneys from HCV+ donors can shorten patients waiting time on the deceased waiting 
list(17). This in turn results in improved survival and overall quality of life and decreased 
health care costs. A cost effectiveness analysis compared the cost associated with accepting 
HCV+ donor kidney followed by DAAs vs remaining on dialysis while awaiting for HCV- 
kidney found a total cost saving of about $138,000 per patient(18). 
 
We believe HCV positive donor organs are being underutilized in the current era of DAAs. 
We hope to provide further proof to the safety and utility of the strategy of transplanting 
HCV positive donor into negative recipient. We hope such proof will encourage transplant 
leaders, organ procurement organizations, and payers to invest into building an 
infrastructure that can turn such strategy into standard of care and ensure access and 
coverage for a variable selection of HCV therapies. 
 
III. 
Procedures  
a. Research design: 


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This will be an open label, prospective, interventional, proof of concept study to 
evaluate the feasibility and safety of kidney transplant from HCV positive donors into 
HCV negative donor using Sofosbuvir/Velpatasvir as the preferred treatment choice for 
post-transplant HCV transmission. 
 
The Ohio (OSUMC) has performed HCV+ into HCV- recipient liver transplants as standard 
of care since February of 2019. OSUMC has also been performing transplant of liver and 
kidneys from donors who are HCV antibody positive but PCR negative (non-viremic 
donors) since 2016. In order to present an overall picture of the patient outcomes 
across multiple types of organ transplants using HCV+ organs, we would like to review 
data from these liver and kidney transplant patients. To do so, retrospective data from 
recipients of HCV positive into negative liver transplants, and HCV antibody positive but 
PCR negative liver and kidney transplant recipients will be analyzed. Patients who were 
treated between January 19th, 2016 and November 26th, 2019 will be included in our 
analysis.  
In order to confirm the safety of transplants using HCV+ kidneys, we will compare the 
outcomes of transplant from HCV viremic donors (HCV PCR+) to those from HCV non 
viremic doors (donors with HCV antibody neg/PCR negative and HCV antibody 
positive/PCR negative). To do so, we will retrospectively review charts of patients who 
received a kidney transplant at OSU between 1/1/2018 and 8/1/2020. This review will 
include recipients of HCV antibody negative/PCR negative (antibody (ab)-/Nucleic 
Antigen Test (NAT)-), HCV antibody positive/PCR negative (ab+/Nat-), and HCV antibody 
positive/PCR positive (ab+/Nat+). 
 
b. Study sample: 
The study will aim to enroll 55 patients. Giving the fact this is a proof of concept study, a 
sample size cannot be calculated based on power analysis. 
Patients will be screened by a research nurse after completion of their pre-transplant 
evaluation. Patient who meets all inclusion and none of the exclusion criteria will be 
approached for consent. The consent will be discussed and explained to patient by a 
physician or research coordinator. 
 
Inclusion criteria: 
Adult age >18 years able to provide consent  
Lack of available living donor  
Calculated pre-transplant reactive panel (cPRA) of <80% 
Estimated post-transplant survival (EPTS) index >20% and <80% 
Negative pre-transplant HIV, HCV, and HBV serology and blood PCR 
No clinically significant pre-transplant liver disease  
Contraception based on the REMS protocol  
Agree to abstinence form alcohol for at least 6 months post-transplant 
Exclusion criteria: 
Living donor available  
Dialysis time >5 years  


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History of previous organ transplantation  
Listing for multi-organ transplantation  
Active or recent history (<6 months) of alcohol or substance abuse  
Clinically significant liver disease as determined by principal investigator  
History of hepatocarcinoma  
Pregnancy or lactation  
Refusal to accept blood transfusion  
HIV infection  
HCV pcr or antibody positive  
HBV infection  
Any condition that in the opinion of the investigator would impair the patients’ ability to 
comply with the study procedures 
Donor selection criteria; 
Positive HCV PCR at time of donation  
KDPI<85% 
 
For the retrospective chart review of HCV+ liver/HCV- recipients and HCV antibody 
positive/PCR negative liver and kidney transplant recipients, we aim to review 78 charts. 
The Ohio State University has so far performed 11 HCV+ into negative liver transplant, 
25 HCV ab+/PCR negative kidney transplant and 25 HCV ab+/PCR negative liver 
transplant so far., Since this is a retrospective chart review portion of the study, a waiver 
of consent and HIPAA authorization will be requested for this portion of the study.  
 
c. Measurements/End points: 
Primary efficacy end point is the proportion of patients with undetectable HCV PCR at 
12 weeks after completion of HCV treatment with Sofosbuvir/Velpatasvir 
Primary safety end point: The incidence of adverse events related to DAA treatment  
Secondary end points: 
eGFR and serum creatinine at 6 and 12 months post-transplant  
Patient’s survival at 6 and 12 months  
Graft’s survival at 12 months  
 
d. Detailed study procedures: 
After completion of post-transplant evaluation and signing informed concept, patient 
status at UNOS will be changed to “Willing to accept HCV+ organ”. Once an organ 
become available, it will be offered to the patients on HCV+ list per UNOS points system. 
Care following receiving HCV+ donor kidney for study patients will be as follow  
1. Induction/maintenance therapy: 
I. 
Patient will receive induction with Thymoglobulin (rabbit ATG) for a 
total dose of 4-6 mg/kg per routine center protocol. Thymoglobulin 
induction will be started on day 0 after transplant surgery. 
II. 
Maintenance immunosuppressive therapy: patient enrolled in the study 
will receive the same routine maintenance immunosuppressive therapy 
used for recipients of HCV negative kidneys in our center. Maintenance 


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therapy will be started on post-operative day 1 with Tacrolimus, 
Mycophenolic acid, and rapid prednisone taper. Tacrolimus will be 
started at a weight based total dose of 0.15 mg/kg divided into two 
daily doses 12 hours apart. Trough levels will be checked daily prior to 
morning dose while inpatient and dose will be adjusted to target trough 
level of 8-12 for the first three months. Trough levels target in enrolled 
patients will follow our center post-transplant Tacrolimus trough target. 
Mycophenolic acid will be started at dose of 720 mg twice daily on post-
Operative day one and continued long term. Dose can be 
adjusted/reduced per patient’s primary transplant physician as 
appropriate due to side effect or infectious complications. Prednisone 
therapy will be tapered off by day 4 per center protocol  
2. Hepatitis C evaluation and treatment:  
I. 
Recipients will have HCV PCR checked on admission day 0 prior to 
kidney transplant, and on day 3 prior to discharge. Patient with negative 
HCV PCR prior to discharge will have PCR checked weekly for 8 weeks 
then monthly up to 12 months post-transplant until PCR is positive. 
Checks will be stopped once PCR is positive. Patients with positive HCV 
PCR at day 3 post-transplant will not have further weekly or monthly 
checks but will follow the during treatment/post-treatment HCV PCR 
schedule mentioned below in section 2.3.d.  
 
II. 
Hepatology consult will be placed automatically on day 0 of transplant 
index admission and again if the patient is symptomatic for HCV. 
III. 
 Direct acting anti-viral drugs (DAAs) will be initiated within eight weeks 
of first positive HCV PCR. 
a. Sofosbuvir/Velpatasvir will be first line therapy. Treatment will 
be with one tablet a day for 12 weeks.  
b. Glecaprevir/Pibrentasvir will be a second line therapy for 
patients with delayed graft function or poor graft function 
(eGFR <30) two weeks post-transplant. Glecaprevir/Pibrentasvir 
doesn’t require renal dose adjustment. Treatment will be with 3 
tablets daily for 12 weeks. 
c. Other FDA approved DAAs could be utilized as potential third 
line therapies if the first and second line therapies are not 
approved by insurance or patient could have a potential drug to 
drug interactions 
d. Patient will receive follow up HCV PCR on week 4 and week 12 
of therapy. HCV PCR will be repeated on week 12 following 
completion of DAA therapy.  
3. Clinic schedule follow up: 
I. 
Patient will be seen in the transplant clinic per routine post-transplant 
protocol; weekly x4, then on weeks 6, 9 and 12, then months 4,6,9 and 
12, 18 and 24. 


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II. 
Patient will be seen by Hepatology only if the patient is symptomatic for 
HCV. 
4. Laboratory schedule: 
I. 
Patient will have CBC, Chem-7, and Tacrolimus trough levels drawn 
twice weekly for the first 12 weeks, then once a week 3-6 months, then 
every two weeks 6-12 months, then once a month thereafter (standard 
of care) 
II. 
Liver function test (LFTs), Prothrombin time (PT), and Partial 
Thromplastin Time (PTT) will be checked weekly for the first 12 weeks 
then quarterly per center protocol  
III. 
HCV PCR will be checked on week 4 and week 12 of therapy. HCV PCR 
will be repeated on week 12 following completion of DAA therapy then 
quarterly for one year Lipid profile, HbA1c, iron studies and alloscreen 
will be checked per center protocol   
e. Data and statistical analysis: 
I. 
Data presented will be mostly a descriptive data giving low 
number of enrolled patient and lack of adequate power analysis 
II. 
We will collect the following data points for retrospective chart 
review:  
a. Recipient: medical record number, transplant date, 
patient demographics, blood type, End-stage liver disease 
etiology, Model for end stage liver disease (MELD) score at 
transplant, end stage renal disease etiology, time of 
dialysis prior to transplant, CMV status for donor and 
recipient, Epstein-Barr virus (EBV) status, and post-
transplant HCV activation, and post-transplant treatment 
information 
b. Donor: demographics, cause of death, CMV status, EBV 
status, HCV genotype 
III. 
[] This will also be a descriptive analysis. Continuous variables will 
be expressed as median and interquartile ranges. Discrete 
variables will be expressed as percentage. Any p-values will be 
significant if <0.05  
 
 
IV. 
Bibliography  
1a.         USRDS Annual Data Report 2017. https://www.usrds.org/2017/view/Default.aspx 
1. 
Hart A, Smith JM, Skeans MA, Gustafson SK, Wilk AR, Robinson A, et al. OPTN/SRTR 2016 Annual 
Data Report: Kidney. Am J Transplant. 2018;18 Suppl 1:18-113. 


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2. 
Curry MP, O'Leary JG, Bzowej N, Muir AJ, Korenblat KM, Fenkel JM, et al. Sofosbuvir and 
Velpatasvir for HCV in Patients with Decompensated Cirrhosis. N Engl J Med. 2015;373(27):2618-28. 
3. 
Feld JJ, Jacobson IM, Hezode C, Asselah T, Ruane PJ, Gruener N, et al. Sofosbuvir and Velpatasvir 
for HCV Genotype 1, 2, 4, 5, and 6 Infection. N Engl J Med. 2015;373(27):2599-607. 
4. 
Feld JJ, Moreno C, Trinh R, Tam E, Bourgeois S, Horsmans Y, et al. Sustained virologic response of 
100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 
12weeks. J Hepatol. 2016;64(2):301-7. 
5. 
Foster GR, Afdhal N, Roberts SK, Brau N, Gane EJ, Pianko S, et al. Sofosbuvir and Velpatasvir for 
HCV Genotype 2 and 3 Infection. N Engl J Med. 2015;373(27):2608-17. 
6. 
Younossi ZM, Stepanova M, Sulkowski M, Foster GR, Reau N, Mangia A, et al. Ribavirin-Free 
Regimen With Sofosbuvir and Velpatasvir Is Associated With High Efficacy and Improvement of Patient-
Reported Outcomes in Patients With Genotypes 2 and 3 Chronic Hepatitis C: Results From Astral-2 and -
3 Clinical Trials. Clin Infect Dis. 2016;63(8):1042-8. 
7. 
Agarwal K, Castells L, Mullhaupt B, Rosenberg WMC, McNabb B, Arterburn S, et al. 
Sofosbuvir/velpatasvir for 12weeks in genotype 1-4 HCV-infected liver transplant recipients. J Hepatol. 
2018;69(3):603-7. 
8. 
Reau N, Kwo PY, Rhee S, Brown RS, Jr., Agarwal K, Angus P, et al. Glecaprevir/pibrentasvir 
treatment in liver or kidney transplant patients with hepatitis C virus infection. Hepatology. 2018. 
9. 
Durand CM, Bowring MG, Brown DM, Chattergoon MA, Massaccesi G, Bair N, et al. Direct-Acting 
Antiviral Prophylaxis in Kidney Transplantation From Hepatitis C Virus-Infected Donors to Noninfected 
Recipients: An Open-Label Nonrandomized Trial. Ann Intern Med. 2018;168(8):533-40. 
10. 
Reese PP, Abt PL, Blumberg EA, Van Deerlin VM, Bloom RD, Potluri VS, et al. Twelve-Month 
Outcomes After Transplant of Hepatitis C-Infected Kidneys Into Uninfected Recipients: A Single-Group 
Trial. Ann Intern Med. 2018. 
11. 
Schlendorf KH, Zalawadiya S, Shah AS, Wigger M, Chung CY, Smith S, et al. Early outcomes using 
hepatitis C-positive donors for cardiac transplantation in the era of effective direct-acting anti-viral 
therapies. J Heart Lung Transplant. 2018;37(6):763-9. 
12. 
Abdelbasit A, Hirji A, Halloran K, Weinkauf J, Kapasi A, Lien D, et al. Lung Transplantation from 
Hepatitis C Viremic Donors to Uninfected Recipients. Am J Respir Crit Care Med. 2018;197(11):1492-6. 
13. 
Khan B, Singer LG, Lilly LB, Chaparro C, Martinu T, Juvet S, et al. Successful Lung Transplantation 
From Hepatitis C Positive Donor to Seronegative Recipient. Am J Transplant. 2017;17(4):1129-31. 
14. 
De Keyzer K, Van Laecke S, Peeters P, Vanholder R. Human cytomegalovirus and kidney 
transplantation: a clinician's update. Am J Kidney Dis. 2011;58(1):118-26. 
15. 
Sagedal S, Hartmann A, Nordal KP, Osnes K, Leivestad T, Foss A, et al. Impact of early 
cytomegalovirus infection and disease on long-term recipient and kidney graft survival. Kidney Int. 
2004;66(1):329-37. 
16. 
Reese PP, Abt PL, Blumberg EA, Goldberg DS. Transplanting Hepatitis C-Positive Kidneys. N Engl J 
Med. 2015;373(4):303-5. 
17. 
Kucirka LM, Peters TG, Segev DL. Impact of donor hepatitis C virus infection status on death and 
need for liver transplant in hepatitis C virus-positive kidney transplant recipients. Am J Kidney Dis. 
2012;60(1):112-20. 
18. 
Gupta G, Zhang Y, Carroll NV, Sterling RK. Cost Effectiveness of Hepatitis C Positive Donor Kidney 
Transplantation for Hepatitis C Negative Recipients with Concomitant Direct-Acting Anti-Viral Therapy. 
Am J Transplant. 2018. 
 
 


IRB#: 2018H0499 
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The Ohio State University Combined Consent to Participate in 
Research and HIPAA Research Authorization 
 
 
Study Title: Utilization of Hepatitis C Positive Kidneys in Negative recipients (USE-
Hep C) 
 
Principal Investigator: Reem Daloul, MD 
 
Sponsor: None 
 
 
• This is a consent form for research participation.  It contains important information 
about this study and what to expect if you decide to participate.  Please consider the 
information carefully. Feel free to discuss the study with your friends and family and to 
ask questions before making your decision whether or not to participate. 
• Your participation is voluntary.  You may refuse to participate in this study.  If you 
decide to take part in the study, you may leave the study at any time.  No matter what 
decision you make, there will be no penalty to you and you will not lose any of your 
usual benefits.  Your decision will not affect your future relationship with The Ohio State 
University.  If you are a student or employee at Ohio State, your decision will not affect 
your grades or employment status. 
• You may or may not benefit as a result of participating in this study.  Also, as explained 
below, your participation may result in unintended or harmful effects for you that may 
be minor or may be serious depending on the nature of the research. 
• You will be provided with any new information that develops during the study that 
may affect your decision whether or not to continue to participate.  If you decide to 
participate, you will be asked to sign this form and will receive a copy of the form.  You 
are being asked to consider participating in this study for the reasons explained below.   
 
1.   Why is this study being done? 
 
You are being invited to participate in a study that aims to evaluate the safety of 
transplanting hepatitis C virus (HCV) infected kidneys in recipients who have never been 
infected with HCV. Following transplant, patients will be given very effective medicine to 
treat the HCV infection. 


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HCV is one of several viruses that infects the liver. It can be transmitted, or passed, from 
one person to the other through blood products, sexual contact, or organ transplant. It is 
estimated that about 3.5 million people in the United States are infected with HCV. There 
are several types of HCV, called genotypes. These are given the numbers 1 to 6 to name 
each genotype.  
 
Hepatitis C infection describes the inflammation (redness and swelling) of the liver tissue 
caused by HCV virus. The disease usually produces no symptoms and many patients do not 
realize they are infected. The inflammation of the liver usually progresses slowly over the 
years until it leads to complete scarring of the liver, or what is called “end stage liver disease 
or cirrhosis”. Concurrent use of anti-rejection drugs can accelerate the damage caused by 
HCV virus if the virus is not treated or fails to respond to treatment. Patients with end stage 
liver disease require liver transplant to stay alive.  
 
Previously, kidneys from donors infected with HCV have only been given to patients on the 
kidney transplant list who also have HCV. This is because the virus passing to the recipient is 
almost guaranteed. Due to the low number of infected transplant patients, most of the 
infected kidneys get discarded and go without good use, despite being quality organs. 
About 800 HCV infected kidneys are wasted each year.  
 
In the last several years, new and highly effective anti-viral drugs, or medicines that treat 
viral infections, for HCV have become available. These drugs are called direct anti-viral drugs 
(DAAs), and they inhibit the virus reproduction and can lead to cure of the disease. The cure 
rate for most of these drugs range between 95-100%. These drugs have made the 
treatment of HCV infection easy, and they are usually well tolerated by patients. We plan to 
use these drugs to treat HCV infection after transplanting infected kidneys. We believe this 
will allow us to decrease the numbers of wasted kidneys and increase the number of 
patients receiving kidney transplant every year.  
 
The main study drug, Sofosbuvir/Velpatasvir (Epclusa), is FDA approved for treatment of 
HCV. It is a daily tablet that is given for 12 weeks. The cure rate for Epclusa is between 95-
100% and works against all 6 types of HCV. This drug has been used to treat HCV infection in 
transplant patients and has had a 96% success rate. Epclusa was well tolerated by patients 
and did not interfere with anti-rejection medications. 


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Some patients may experience delayed or poor graft function. In these patients, a different 
anti-HCV drug will be used. Glecaprevir/pibrentasvir (MAVYRET) is given as 3 tablets daily 
over 12 weeks. The cure rate for Mavyret is also between 95-100% and it is effective against 
all 6 types of HCV. It has also been shown to be successful in HCV infected transplant 
patients.  
 
Other FDA approved drugs for treatment of hepatitis C, such as Sofosbuvir/Ledipasvir 
(Harvoni) or Elbasvir/Grazoprevir (Zepatier), will be used in case your health insurance 
denies coverage for first and second line therapy.  
 
Patients who have history of hepatitis B virus infection of the liver might have activation of 
their infection when taking direct anti-viral drugs (DAAs). You will be screened for HBV 
infection prior to enrollment and will not be enrolled in the study if you tested positive. 
 
If you join the study, you will receive the exact same care you would have received if you 
decided not to be part of the study. The only difference would be the addition of the study 
drug and a blood test to monitor for HCV infection called HCV PCR. The blood work for HCV 
infection will be drawn at the same time you get your routine blood work for transplant. 
There will be no need for any additional blood testing. 
 
2.   How many people will take part in this study? 
 
We plan to enroll 55 patients in this study.  
 
3.   What will happen if I take part in this study? 
 
After Enrollment 
Once you are enrolled in the study, your status on the kidney waiting system will be 
changed to “Accepting HCV+ organ”. Once an organ becomes available, it will be offered to 
you. You have the chance to turn down the offer and withdraw from the study at any point. 


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After Transplant 
After transplant, you will receive the routine care that any other kidney transplant recipient 
patient normally gets. In addition, we will be monitoring you for HCV infection using a blood 
test called HCV Polymerase Chain Reaction (PCR). The first check will be on day three post-
transplant. If this first test is not positive, you will have blood tests every week for 8 weeks 
or until the test is positive. If after 8 weeks the test is still negative, we will monitor HCV 
infection every month until the test is positive or until 12 months is reached.  
 
You will be seen by the Hepatologist (liver doctor) while inpatient and again only if you 
would become symptomatic. 
 
Once HCV PCR becomes positive, you will start treatment with the anti-viral drug Epclusa 
(sofosbuvir/velpatasvir). One tab of Epclusa will be taken daily for 12 weeks. At the end of 
the treatment period, we will repeat the HCV blood test to confirm if the treatment worked. 
We will repeat the blood test again in the future to confirm the treatment worked and that 
the infection has not come back. If you have delayed graft function or poor graft function, 
you will be put on MAVYRET (glecaprevir/pibrentasvir) instead of Epclusa. This drug requires 
you take 3 tablets daily for 12 weeks. If insurance denies coverage to both of these drugs, 
you will be treated with either Zepatier (Elbasvir/Grazoprevir) or Harvoni 
(Sofosbuvir/Ledipasvir). The treatment with either of these two drugs is one tablet daily for 
12 weeks. As with Epclusa, blood tests will be repeated to determine whether the 
treatment worked.  
Clinic Follow-up 
You will have the same clinic follow-up as other kidney transplant patients. This means you 
will be seen in clinic every week between weeks 1 and 4, then on weeks 6, 9, and 12 post-
transplant. You will then be seen on months 4, 6, 9, and 12 post-transplant.  
 
A table showing the expected schedule of study and clinic activities is shown below. 
 
Activity 
Day 0 
pre-
transplant 
Day 3 
post-
transplant 
Wk1 Wk2 Wk3 Wk4 Wk6 Wk9 Wk12 Mo4 Mo6 Mo9 Mo12 
 
Physical 
examination 
and blood 
work(HCV 
X 
 
 
 
 
 
 
 
 
 
 
 
 


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PCR, Hep 
B and HIV 
testing 
Transplant 
clinic visit 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
HCV 
PCRa,b 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
a Patients with a positive HCV PCR at Day 3 post-transplant will receive a follow up HCV PCR on Week 
4 and Week 12 of therapy. 
b Patients with a negative HCV PCR prior to discharge will have an HCV PCR checked weekly for 8 
weeks, then monthly until Month 12. 
 
What Are Your Responsibilities During The Study? 
In order for this study to provide good information about how the study drugs work, you 
will be asked to do the following: 
• Take all study drugs with food and as directed by your study doctor. 
• Follow the instructions of your study doctor including requirements to use 
appropriate birth control methods. 
• Come to all your scheduled visits and procedures.  Let your study doctor know as 
soon as possible if you are not able to attend a visit so that they can work with you 
to make other arrangements. 
• Review all the medications you are taking with your study doctor.  You may have to 
stop or adjust the dose of certain medications and supplements before or during the 
study. 
• Do not change, start or stop any medications without checking first with your study 
doctor. 
• Tell the study staff what medical procedures/conditions you have had in the past.  
Some procedures/conditions you may have had in the past may keep you from being 
in this study. 
• Tell the study staff about any health problems or side affects you are having even if 
you don't think they are important or related to the study drugs or if you have made 
any visits to other doctors or hospitals. 
• Tell the study staff if you wish to stop being in the study. 
• Do not participate in any other research studies during your participation in this 
study. 
• Avoid drinking alcohol for at least 6 months post-transplant. 
• In the event of an emergency, dial your local emergency phone number 
immediately. 
• If you require emergency care, be sure to tell the emergency care provider about 
your participation in this study.  Contact the study doctor or study staff as soon as 
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Study Drug Instructions: 
• You will receive specific instructions on how to take all of the study drugs.  You will 
have a discussion with your study doctor or staff about the importance of taking your 
study drugs with food and at the same time each day.  Should you miss taking a dose 
at a scheduled time, it is important that you tell your study doctor at your next visit.  
If you decide to stop taking your study drugs, it is very important that you tell your 
study doctor right away. 
• Take and store your study drug as instructed and return the unused study drug 
and/or empty containers to the study doctor's office at each visit.  Do not share your 
study drug with anyone.  You are the only person allowed to take the study drug.  
Keep the study drug and study supplies out of the reach of children and persons of 
limited ability to read or understand 
 
4.   How long will I be in the study? 
 
It is difficult to say exactly how long you will be in this study since we do not know how long 
it will take for a donor organ to become available once your status is changed with UNOS 
(United Network for Organ Sharing). However, you will be in the study for up to 1 year 
following your transplant. It is estimated that the maximum amount of time you will 
dedicate to study specific visits is 5 hours over this 1 year period. This is based on need for 
study initiation visit (about 20-30 minutes including time for blood draw), post-transplant 
HCV blood tests (variable numbers. A total of 5-6 HCV blood test post-transplant is expected 
in 99% of the patients. Less than 1% of the patients might need more frequent HCV tests, up 
to a maximum of 21 tests) and any applicable Hepatology clinic visits (approximately 30 
minutes each). Your exact time commitment will be dependent on how long it takes for you 
to have a positive HCV result and whether you require a second round of HCV treatment. 
When possible, blood draws will be done at the same time as regular transplant visits to 
minimize extra time commitment.  
 
5. Can I stop being in the study? 
 
You may leave the study at any time.  If you decide to stop participating in the study, there 
will be no penalty to you, and you will not lose any benefits to which you are otherwise 
entitled.  Your decision will not affect your future relationship with The Ohio State 
University. If you leave the study before transplant, you can be listed back the deceased 


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waiting list. Your participation in the study will not affect in any way your position on the 
deceased waiting list. 
 
While you can leave the study at any time, stopping study drugs before the study drug has 
been completed can reduce the chance that the HCV infection will be successfully cured. In 
addition, stopping study medication before the treatment has been completed might 
increase the chance that your HCV will develop resistance to one or all of these drugs. It is 
possible that virus with resistance to these drugs may also be more difficult to treat in the 
future with other anti HCV drugs. 
 
6.   What risks, side effects or discomforts can I expect from being in the study? 
 
Risk of contracting HCV 
The main risk associated with this study is becoming infected with HCV. The likelihood that 
you will get this infection from the donor is close to 100%. However, we will monitor your 
blood for signs of infection very closely and we will start treatment with the anti-viral as 
soon as we discover the earliest sign of infection. The cure rate with any of the anti-viral 
drugs is more than 95%. There is a very small chance (less than 5%) that you will not be 
cured after the first round of treatment. In this case, a second round (another 12 weeks for 
Epclusa or Mavyret) of treatment will be needed. Most patients will be infection free after 1 
or 2 treatment rounds. If you fail to clear the infection, you might develop severe liver 
disease. 
 
There is a risk that your HCV may become resistant to the specific study drug you are treated 
with during this study. The risk that your HCV will develop resistance is unknown.  It is also 
not known how long HCV might remain resistant to the specific drug after you stop taking it.  
Resistance to one study drug may lead to resistance to other anti-HCV drugs called DAAs, 
similar to the ones taken in this study, and this could affect your response to treatment with 
DAAs in the future.  During the course of this study, you will be monitored for the 
development of resistance. 
 
If you are infected with HCV, there is the risk of you passing this infection to the people you 
contact. HCV is believed to be most efficiently passed from the blood of one person to the 
blood of another. Following your transplant, care should be taken to not share items that may 
have blood on them (e.g. razorblades, toothbrushes, needles) and to keep open cuts or 
wounds properly covered.   Although rare, HCV can also be passed through sexual contact. 
Sexual contact that includes contact with blood of an infected individual increases the 
likelihood of the virus being passed. 
Risks of the Epclusa, MAVYRET, Harvoni, Zepatier 


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The most common side effects experienced following treatment with one of the DAAs (more 
than 10% of patients) were: fatigue, headache, and nausea. Less commonly experienced side 
effects include insomnia, irritability, cough, skin rash, and indigestion. 
 
Sometimes people have allergic reactions to these drugs. In extreme cases, an allergic 
reaction may lead to death. Some symptoms of a life-threatening allergic reaction 
(anaphylaxis) are: 
• A rash 
• Difficulty breathing 
• Wheezing 
• A sudden drop in blood pressure. (making you feel dizzy or lightheaded) 
• Swelling around the mouth, throat, or eyes 
• A fast pulse 
• Sweating 
 
You should get immediate medical attention if you experience any of these signs of a serious 
allergic reaction. If you experience any side effects during the study, please contact the study 
doctor or staff to report what you are experiencing. 
Reproductive risks 
Studies conducted in animal showed that Epclusa did not result in harmful effects to the 
fetus. However, such studies have not be conducted in humans and hence the effect of 
Epclusa in pregnancy is not known.  
Additionally, anti-rejection medications are known to have risks of first trimester pregnancy 
loss and congenital malformation. 
Females: 
If you are a sexually active female able to have children, you must use two forms of 
contraception simultaneously unless complete abstinence from heterosexual intercourse is 
your chosen method. The study doctor must approve the methods of birth control that you 
will be using and you must agree to continue using those methods of birth control following 
completion of the study. 
Medically proven methods of birth control can include oral or implanted hormonal 
contraceptives like the pill, barrier methods (e.g., condom with spermicide, diaphragm or 
vaginal cap with spermicide), or sexual abstinence. If you are a woman and have been 
surgically sterilized or you are in menopause (at least 12 consecutive months without 
menses) you do not need to use contraceptive methods. 
In case you discontinue study drug but continue taking mycophenolate mofetil (MMF), a 
medicine used to weaken your immune system so you do not reject your new organ, you 
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Males: 
Unless you have a previous history of vasectomy, you must agree to consistently use a 
condom during heterosexual interaction.  In addition, you must agree not to donate sperm 
from Study Day 1 through 7 months after the last dose of study drug 
Loss of Confidentiality 
Any time data is collected on a participant, there is the risk this information may be accessed 
by someone outside of the study. All precautions will be taken to avoid loss of confidentiality 
such as storing information in a locked office, on a protected computer and secure network. 
Any loose paper containing participant information will be stored in a locked office and 
locked cabinet. Only study personnel will have access to this information. 
Study drug interactions 
It is possible that taking the study drugs with your regular medications or supplements may 
change how the study drugs, your regular medications (such as atorvastatin, Prilosec, 
warfarin, colchicine and amiodarone), or your regular supplements work. It is very important 
that you tell the study doctor about all medications or supplements you are taking during the 
study including those you take as needed or which you take only occasionally. Your 
medication list will be reviewed during each clinic visit to confirm there is no dangerous or 
significant drug-drug interaction. 
If you stop or change your regular medication to be in the study, your health might get worse. 
Please tell the study doctor or study staff right away if you have any problems when you stop 
taking or change your regular medication. 
 
7.   What benefits can I expect from being in the study? 
 
If you decide to join the study, you will be listed on the HCV positive kidney waiting list. 
The wait time on this list is much shorter, usually between 3-6 months compared to 2-5 
years on the regular kidney waiting list. Additionally, donors who have HCV infection are 
usually younger and otherwise healthier. This means the quality of the organ is usually, 
though not always, better than average. 
 
8.   What other choices do I have if I do not take part in the study? 
 
You may choose not to participate without penalty or loss of benefits to which you are 
otherwise entitled. You do not have to participate in this study to receive kidney transplant. 


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Your study doctor can discuss the risks and advantages of alternative treatment methods 
with you. 
 
9. What are the costs of taking part in this study? 
 
The transplant and your regular post-transplant treatment are standard of care and will not 
be covered by this study. You or your insurance company will be billed for the transplant 
surgery and any standard of care clinic visits. You will be responsible for any out of pocket 
expenses associated with your insurance plan. In the unlikely event you incur unexpected 
costs related to therapy, the study team will work with you to help cover the costs.  
 
10. Will I be paid for taking part in this study? 
 
Participation in the study is completely voluntary. There will not be any financial 
reimbursement or incentives to being part of the study. 
 
11. What happens if I am injured because I took part in this study? 
 
If you suffer an injury from participating in this study, you should notify the researcher or 
study doctor immediately, who will determine if you should obtain medical treatment at 
The Ohio State University Wexner Medical Center.   
 
The cost for this treatment will be billed to you or your medical or hospital insurance. The 
Ohio State University has no funds set aside for the payment of health care expenses for 
this study.  
 
12. What are my rights if I take part in this study? 
 
If you choose to participate in the study, you may discontinue participation at any time 
without penalty or loss of benefits.  By signing this form, you do not give up any personal 
legal rights you may have as a participant in this study. 


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You will be provided with any new information that develops during the course of the 
research that may affect your decision whether or not to continue participation in the 
study. 
 
You may refuse to participate in this study without penalty or loss of benefits to which you 
are otherwise entitled. 
 
An Institutional Review Board responsible for human subjects research at The Ohio State 
University reviewed this research project and found it to be acceptable, according to 
applicable state and federal regulations and University policies designed to protect the 
rights and welfare of participants in research. 
 
13. Will my study-related information be kept confidential? 
 
Efforts will be made to keep your study-related information confidential.  However, there 
may be circumstances where this information must be released.  For example, personal 
information regarding your participation in this study may be disclosed if required by state 
law.   
 
Also, your records may be reviewed by the following groups (as applicable to the research): 
• 
Office for Human Research Protections or other federal, state, or international 
regulatory agencies; 
• 
U.S. Food and Drug Administration; 
• 
The Ohio State University Institutional Review Board or Office of Responsible 
Research Practices; 
• 
The sponsor supporting the study, their agents or study monitors; and 
• 
Your insurance company (if charges are billed to insurance). 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. law.  This website will not include information that can identify you.  At 
most, the website will include a summary of the results.  You can search the website at any 
time.  
 
14. HIPAA AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR 
      RESEARCH PURPOSES  
 
I. 
What information may be used and given to others? 


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• Past and present medical records; 
• Research records; 
• Records about phone calls made as part of this research; 
• Records about your study visits; 
• Information that includes personal identifiers, such as your name, or a number 
associated with you as an individual; 
• Information gathered for this research about: 
HIV / AIDS 
Hepatitis infection 
Sexually transmitted diseases 
Other reportable infectious diseases 
Physical exams 
Laboratory, x-ray, and other test results 
• Records about any study drug you received; 
 
II. 
Who may use and give out information about you? 
 
Researchers and study staff.   
 
III. 
Who might get this information? 
 
• The sponsor of this research.  “Sponsor” means any persons or companies that are: 
• working for or with the sponsor; or  
• owned by the sponsor. 
• Authorized Ohio State University staff not involved in the study may be aware that 
you are participating in a research study and have access to your information; 
• If this study is related to your medical care, your study-related information may be 
placed in your permanent hospital, clinic or physician’s office record; 
 
IV. 
 Your information may be given to: 
  
• The U.S. Food and Drug Administration (FDA), Department of Health and Human 
Services (DHHS) agencies, and other federal and state entities; 


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• Governmental agencies in other countries; 
• Governmental agencies to whom certain diseases (reportable diseases) must be 
reported; and  
• The Ohio State University units involved in managing and approving the research 
study including the Office of Research and the Office of Responsible Research 
Practices. 
 
V. 
Why will this information be used and/or given to others? 
 
• To do the research;  
• To study the results; and  
• To make sure that the research was done right.   
 
VI. 
 When will my permission end? 
 
There is no date at which your permission ends. Your information will be used indefinitely. 
This is because the information used and created during the study may be analyzed for 
many years, and it is not possible to know when this will be complete. 
 
VII. May I withdraw or revoke (cancel) my permission? 
 
Yes. Your authorization will be good for the time period indicated above unless you change 
your mind and revoke it in writing. You may withdraw or take away your permission to use 
and disclose your health information at any time. You do this by sending written notice to 
the researchers. If you withdraw your permission, you will not be able to stay in this study. 
When you withdraw your permission, no new health information identifying you will be 
gathered after that date. Information that has already been gathered may still be used and 
given to others. 
 
VIII. What if I decide not to give permission to use and give out my health 
information? 
 
Then you will not be able to be in this research study and receive research-related 
treatment.  However, if you are being treated as a patient here, you will still be able to 
receive care. 


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IX. 
 Is my health information protected after it has been given to others? 
 
There is a risk that your information will be given to others without your permission. Any 
information that is shared may no longer be protected by federal privacy rules. 
 
X. 
May I review or copy my information? 
 
Signing this authorization also means that you may not be able to see or copy your study-
related information until the study is completed.   
 
 
15. Who can answer my questions about the study? 
 
For questions, concerns, or complaints about the study, or if you feel you have been 
harmed as a result of study participation, you may contact Dr. Reem Daloul at 
____reem.daloul@osumc.edu_______________. 
 
For questions related to your privacy rights under HIPAA or related to this research 
authorization, please contact HIPAA Privacy Officer, Suite E2140, 600 Ackerman Road, 
Columbus, OH  43201. 
 
 
For questions about your rights as a participant in this study or to discuss other study-
related concerns or complaints with someone who is not part of the research team, you 
may contact Ms. Sandra Meadows in the Office of Responsible Research Practices at 1-800-
678-6251. 
 
If you are injured as a result of participating in this study or for questions about a study-
related injury, you may contact Dr. Reem Daloul 
at_____reem.daloul@osumc.edu_______________. 
 


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Signing the consent form 
 
I have read (or someone has read to me) this form and I am aware that I am being asked to 
participate in a research study.  I have had the opportunity to ask questions and have had them 
answered to my satisfaction.  I voluntarily agree to participate in this study.  
 
I am not giving up any legal rights by signing this form.  I will be given a copy of this combined 
consent and HIPAA research authorization form. 
 
 
 
 
 
Printed name of subject 
 
Signature of subject 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
 
 
 
 
 
 
 
Printed name of person authorized to consent for subject 
(when applicable) 
 
Signature of person authorized to consent for subject  
(when applicable) 
 
 
 
 
 
AM/PM 
Relationship to the subject 
 
Date and time 
 
 
 
 
Investigator/Research Staff 
 
I have explained the research to the participant or his/her representative before requesting the 
signature(s) above.  There are no blanks in this document.  A copy of this form has been given 
to the participant or his/her representative. 
 


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Printed name of person obtaining consent 
 
Signature of person obtaining consent 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
Witness(es) - May be left blank if not required by the IRB 
 
 
 
 
 
Printed name of witness 
 
Signature of witness 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
 
 
 
Printed name of witness 
 
Signature of witness 
 
 
 
 
 
 
AM/PM 
 
 
Date and time