**Criteria for Use of Consensus Interferon (Infergen®) in Hepatitis C**

VHA Pharmacy Benefits Management Service and the Medical Advisory Panel

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*These criteria were developed using the best evidence currently
available. The following recommendations are dynamic and will be
revised, as new clinical data become available. These guidelines are not
intended to interfere with clinical judgment. Rather, they are intended
to assist practitioners in providing consistent, high quality cost
effective care.*

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| **Exclusion Criteria (if any box is checked the patient DOES NOT      |
| qualify)**                                                            |
+-----------------------------------------------------------------------+
| -   Patient who is treatment naïve for Hepatitis C (HCV)              |
|                                                                       |
| -   Patient with decompensated cirrhosis                              |
|                                                                       |
| -   Hypersensitivity to alpha interferons and/or to E. coli-derived   |
|     products.                                                         |
|                                                                       |
| -   Life-determining extrahepatic disease (malignancy, unstable       |
|     angina or arrhythmias, CABG or MI in past 12 months, severe COPD) |
|                                                                       |
| -   Uncontrolled autoimmune disorders                                 |
|                                                                       |
| -   Severe uncontrolled psychiatric disease, particularly depression  |
|     with current suicidal risk                                        |
|                                                                       |
| -   Inability to self-administer or to arrange administration of      |
|     parenteral medication                                             |
|                                                                       |
| -   Ongoing injection drug use                                        |
|                                                                       |
| -   Ongoing alcohol abuse                                             |
+-----------------------------------------------------------------------+
| **Inclusion Criteria ( one box must be checked)**                     |
+-----------------------------------------------------------------------+
| -   Patient who is a non responder \[no early virologic response      |
|     (EVR)\] to pegylated interferon/ribavirin therapy for HCV and had |
|     an adequate trial of therapy with documented compliance           |
|                                                                       |
| > or                                                                  |
|                                                                       |
| -   Patient who is a relapser \[no sustained virologic response       |
|     (SVR)\] to pegylated interferon/ribavirin therapy for HCV and had |
|     an adequate trial of therapy with documented compliance           |
|                                                                       |
| > or                                                                  |
|                                                                       |
| -   Patient with no end of treatment response (ETR) to pegylated      |
|     interferon/ribavirin therapy for HCV and had an adequate trial of |
|     therapy with documented compliance                                |
+-----------------------------------------------------------------------+
| **Inclusion Criteria (continued- one box must be checked)**           |
+-----------------------------------------------------------------------+
| -   Ultrasound, CT or MRI evidence of advanced fibrosis or cirrhosis  |
|     (e.g. hepatomegaly with liver nodularity, portal hypertension,    |
|     splenomegaly or esophageal varices)                               |
|                                                                       |
| > or                                                                  |
|                                                                       |
| -   Patient with biopsy proven advanced fibrosis or cirrhosis,        |
|     METAVIR or FibroSure/FibroTest score [\>]{.underline} F2          |
|                                                                       |
| > or                                                                  |
|                                                                       |
| -   Patient with extrahepatic manifestations of HCV such as           |
|     cryoglobulinemias and/or vasculitis                               |
+-----------------------------------------------------------------------+
| **Dosage Recommendations**                                            |
+-----------------------------------------------------------------------+
| -   Consensus interferon 15 µg subcutaneously daily, decrease dose to |
|     9 µg subcutaneously daily if patient is unable to tolerate the    |
|     higher dose; may decrease dosage further to 9 µg three times      |
|     weekly if needed.                                                 |
|                                                                       |
| -   Concurrent weight based ribavirin dose 10.6 mg/kg/day up to 1,200 |
|     mg/day in patients with adequate renal function (Cr \<1.5). In    |
|     some clinical situations, ribavirin doses up to 1400 mg/day may   |
|     be considered in patients with adequate renal function (Cr        |
|     \<1.5).                                                           |
+-----------------------------------------------------------------------+
| **Discontinuation Criteria**                                          |
+-----------------------------------------------------------------------+
| -   Patient who develops decompensated cirrhosis                      |
|                                                                       |
| -   Patient who has \< 2 log decrease in HCV viral load at 12 weeks   |
|     of therapy                                                        |
|                                                                       |
| -   Alpha interferons, including consensus interferon, may cause or   |
|     aggravate fatal or life-threatening neuropsychiatric, autoimmune, |
|     ischemic, and infectious disorders. Patients should be monitored  |
|     closely with periodic clinical and laboratory evaluations.        |
|     Patients with persistently severe or worsening symptoms of these  |
|     conditions should be withdrawn from therapy                       |
+-----------------------------------------------------------------------+
| **Dosage Adjustments**                                                |
+-----------------------------------------------------------------------+
| -   Patient with undetectable HCV viral load by 12 weeks of therapy,  |
|     treat for 48 weeks total                                          |
|                                                                       |
| -   Patient with detectable but ≥2 log decrease in HCV viral load by  |
|     12 weeks of therapy, consider treatment for up to 72 weeks only   |
|     if the patient is HCV PCR negative at 24 weeks                    |
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1.  Yee HS, Tortorice K, Chapman S, Cunningham F, Currie S. Hepatitis C
    Virus (HCV) Treatment Outcomes with consensus interferon with or
    without ribavirin in peginterferon/ribavirin
    nonresponders/relapsers: Results from national clinical practice
    setting. Poster Presentation, 58th Annual Meeting of the American
    Association for the Study of Liver Diseases November 2-6, 2007**,**
    Boston, Massachusetts.

2.  Sjogren MH, Sjogren R, Lyons MF, et al. Antiviral response of HCV
    genotype 1 to consensus interferon and ribavirin versus pegylated
    interferon and ribavirin. Dig Dis Sci.2007 Jun;52(6):1540-7.

> Epub 2007 Apr 4.

3.  Alaimo G, Di Marco V, Ferraro D, et al. Different doses of consensus
    interferon plus ribavirin in patients with hepatitis C virus
    genotype 1 relapsed after interferon monotherapy: a randomized
    controlled trial. World J Gastroenterol. 2006 Nov 14;12(42):6861-4.

4.  Bocher WO, Schuchmann M, Link R, et al. Consensus interferon and
    ribavirin for patients with chronic hepatitis C and failure of
    previous interferon-alpha therapy. Liver Int. 2006 Apr;26(3):319-25.

5.  Cornberg M, Hadem J, Herrmann E,et al. Treatment with daily
    consensus interferon (CIFN) plus ribavirin in non-responder patients
    with chronic hepatitis C: a randomized open-label pilot study. J
    Hepatol. 2006 Feb;44(2):291-301. Epub 2005 Nov 28.

6.  Fattovich G, Zagni I, Minola E, et al. A randomized trial of
    consensus interferon in combination with ribavirin as initial
    treatment for chronic hepatitis C. J Hepatol. 2003 Nov;39(5):843-9.

7.  Kao JH, Chen PJ, Lai MY, Chen DS. Efficacy of consensus interferon
    in the treatment of chronic hepatitis C. J Gastroenterol Hepatol.
    2000 Dec;15(12):1418-23.