Efficacy and Safety of Combination Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) in Genotype 2 Hepatitis C Infection (MK-5172-047)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Grazoprevir; Elbasvir; Ribavirin
Intervention description: 100 mg every day (QD) orally; 50 mg QD orally; Administered twice daily (BID) orally at a total daily dose of 800 mg to 1400 mg based on participant's weight on Day 1
Intervention MeSH terms: Ribavirin; Grazoprevir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multi-site, open-label trial evaluating the safety and efficacy of 100 mg of
      grazoprevir (MK-5172) used in combination with or without 50 mg of elbasvir (MK-8742) and/or
      ribavirin (RBV) in treating non-cirrhotic treatment-naïve participants with chronic genotype
      (GT) 2, 4, 5, and 6 hepatitis C infection.

      In Part A there is no randomization or stratification; all GT2 participants will be assigned
      to arm A1. In Part B, all GT2 participants will be assigned to Arm B1 and all participants
      with GT4, GT5 and GT6 will be randomized in a 1:1 ratio to either Arm 3 or Arm 4 with
      stratification by genotype.
    

Eligibility criteria:

        Inclusion Criteria:

        Parts A and B: -Body weight ≥50 kg (111 lbs) and ≤ 125 kg (275 lbs) -Has absence of
        cirrhosis -Agrees to use two acceptable methods of birth control from at least 2 weeks
        prior to Day 1 and continue until at least 6 months after last dose of study drug, or
        longer if dictated by local regulations (for female participant who is of childbearing
        potential or male participant with female sexual partner who is of childbearing potential).

        Part A only: -Has chronic HCV GT2 infection Part B only: -Has chronic HCV GT2, GT4, GT5, or
        GT6 infection

        Exclusion Criteria:

        Parts A and B:

        -Is not treatment naïve (participant has had previous treatment with any interferon, RBV,
        approved or experimental direct acting antiviral(s), or other investigational therapies for
        HCV) -Is determined to be coinfected with hepatitis B virus (HBsAg positive) or HIV -Has
        evidence of, or is under evaluation for, hepatocellular carcinoma (HCC) -Has a clinical
        diagnosis of substance abuse including the following specified drugs within specified
        timeframes: Alcohol, intravenous drugs, inhalational, psychotropics, narcotics, cocaine
        use, prescription or over-the-counter drugs (within 1 year of the screening visit), is
        receiving opiate agonist substitution therapy (within 1 year of screening visit), or
        excessive historic marijuana use -Has evidence of active or suspected malignancy, or a
        history of malignancy, within the last 5 years -Female participant who is pregnant,
        lactating, expecting to conceive or donate eggs, or is of childbearing potential and
        unwilling to commit to two methods of birth control throughout treatment and after the
        completion of all treatment, or male participant who is planning to impregnate or provide
        sperm donation or has a female sexual partner of childbearing potential and is unwilling to
        commit to using a two methods of birth control throughout treatment and after the
        completion of all treatment -Has evidence or history of chronic hepatitis not caused by
        HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced
        hepatitis, and autoimmune hepatitis. -Has uncontrolled diabetes (documented HbA1c >8.5%)

        Part A only:

        -Has non GT2 HCV infection

        Part B only:

        -Has HCV infection with a genotype other than GT2, GT4, GT5 or GT6