Efficacy and Safety of Combination Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Sofosbuvir + Pegylated Interferon + Ribavirin in Hepatitis C Virus Genotype 1, 4 or 6 Infection (MK-5172-077)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Sofosbuvir; PegIntron; Ribavirin; Grazoprevir/Elbasvir (100 mg/50 mg) FDC
Intervention description: 400 mg tablets, taken orally (PO) every day (QD) for 12 weeks.; PegIntron administered subcutaneously every week (QW) at 1.5 mcg/kg for 12 weeks.; Capsule and/or tablet administered PO twice daily (BID) based on weight (1000 - 1200 mg) for 12 weeks.; Grazoprevir/Elbasvir (100 mg/50 mg) FDC, taken PO QD for 12 weeks.
Intervention MeSH terms: Ribavirin; Sofosbuvir; Peginterferon alfa-2b; Grazoprevir; Elbasvir-grazoprevir drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 257.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study comparing grazoprevir (MK-5172) plus elbasvir (MK-8742) treatment with
      sofosbuvir (SOF) plus Pegylated Interferon plus Ribavirin (RBV) [PR] treatment in
      treatment-naïve and prior PR treatment failure participants with chronic Hepatitis C Virus
      (HCV) genotype (GT)1, GT4, or GT6 infection. The primary objectives are to compare efficacy
      (assessed by the percentage of participants achieving sustained virologic response 12 weeks
      after ending study treatment [SVR12]) and safety between the grazoprevir plus elbasvir
      treatment arm and the SOF plus PR treatment arm. The primary hypothesis is that the
      percentage of participants achieving SVR12 in the grazoprevir plus elbasvir treatment arm is
      non-inferior to that in the SOF plus PR treatment arm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Weigh ≥40 kg and ≤125 kg

          -  documented chronic HCV GT1, GT4, or GT6 infection

          -  cirrhosis/absence of cirrhosis defined by liver biopsy, Fibroscan, or FibroSure®

          -  either treatment naïve or PR Null Responder, PR Partial Responder, or PR Prior
             Relapser

          -  participant and partner both agree to use at least use at least 2 effective methods of
             contraception from at least 2 weeks prior to Day 1 and continue until up to 6 months
             after last dose of study drug, or longer if dictated by local regulations

        Exclusion Criteria:

          -  has evidence of decompensated liver disease

          -  is coinfected with hepatitis B virus (e.g. hepatitis B surface antigen positive) or
             human immunodeficiency virus

          -  history of malignancy ≤5 years prior to signing informed consent, or is under
             evaluation for other active or suspected malignancy

          -  has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of
             hepatocellular carcinoma (HCC) or is under evaluation for HCC

          -  has any of the following conditions: immunologically-mediated disease, organ
             transplants other than cornea and hair, poor venous access that precludes routine
             peripheral blood sampling, history of gastric surgery or malabsorption disorders, or
             any medical condition requiring, or likely to require, chronic systemic administration
             of corticosteroids during the course of the trial, history of chronic hepatitis not
             caused by HCV