Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059)

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks) versus standard 48 week treatment in previously untreated adult participants with chronic hepatitis C (CHC) genotype 4 infection who achieve rapid virologic response (RVR), defined as HCV ribonucleic acid (RNA) negativity after 4 weeks of treatment.

Detailed Description
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Participants who achieved RVR after 4 weeks of PEG-INF alfa-2b plus RBV treatment were randomized to receive either 20 or 44 weeks of continued therapy, for a total of 24 or 48 weeks total of PEG-INF plus RBV therapy.

Official Title
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Randomized Open Label Study to Assess the Efficacy and Safety of Short Course Therapy (24 Weeks) With Peginterferon Alpha-2b and Ribavirin for Chronic Hepatitis C (Genotype 4) Patients Who Achieve a Rapid Virological Response (HCV -RNA Undetectable at Week 4 of Treatment)

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: PEG-IFN alfa-2b
* Drug: ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is ≥40 kg and ≤120 kg weight Participant and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations. Previously documented CHC genotype 4 infection Liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no other etiology and with hepatic fibrosis scores (F0, F1, F2, F3). Exclusion Criteria: Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus Treatment for hepatitis C with any investigational medication Treatment with any investigational drug within 30 days of the screening visit Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy Autoimmune hepatitis or a history of autoimmune disease Hepatic fibrosis score F4 Severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months Autoimmune hepatitis or a history of autoimmune disease Thyroid disease uncontrolled with conventional treatment Epilepsy and/or compromised central nervous system (CNS) function

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 44 Weeks of PEG-IFN alfa-2b + RBV<br>Participants achieving RVR at 4 weeks of treatment will receive 44 additional weeks of Peg-IFN Alfa-2b + RBV. | Drug: PEG-IFN alfa-2b<br>* Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week<br>Drug: ribavirin<br>* Ribavirin 200 mg capsules administered orally daily based on weight<br>|
| Experimental: 20 Weeks of PEG-IFN alfa-2b + RBV<br>Participants achieving RVR at 4 weeks of treatment will receive 20 additional weeks of Peg-IFN Alfa-2b + RBV. | Drug: PEG-IFN alfa-2b<br>* Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week<br>Drug: ribavirin<br>* Ribavirin 200 mg capsules administered orally daily based on weight<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Achieving Sustained Virologic Response (SVR) | SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy. | At 24 weeks after the completion of therapy (up to 72 weeks) |