Efficacy and Safety of Uprifosbuvir (MK-3682) + Ruzasvir (MK-8408) in Treating Hepatitis C Virus Infection Genotypes 1-6 (MK-3682-041)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Uprifosbuvir; Ruzasvir; Ribavirin
Intervention description: Participants take 3 tablets each containing 150 mg uprifosbuvir q.d. by mouth.; Participants take 3 capsules each containing 60 mg RZR q.d. by mouth.; RBV 200 mg capsules will be taken according to package instructions for a maximum of 16 weeks for any GT that meets virologic futility rules on uprifosbuvir + RZR alone.
Intervention MeSH terms: Ribavirin; Ruzasvir; Uprifosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 282.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a nonrandomized, multi-site, open-label trial to evaluate a novel two-drug
      combination regimen (uprifosbuvir [MK-3682] 450 mg + ruzasvir [RZR; MK-8408] 180 mg once
      daily [q.d.] for 12 weeks) in male and female treatment-naïve (TN) or treatment-experienced
      (TE) participants with chronic hepatitis C virus (HCV) infection genotype (GT) GT1, GT2, GT3,
      GT4, GT5, or GT6 who have not previously received HCV direct-acting antiviral (DAA) therapy.
      Cirrhotic (C) and non-cirrhotic (NC) participants with and without human immunodeficiency
      virus (HIV) co-infection will be enrolled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  has HCV ribonucleic acid (RNA) (≥10,000 IU/mL in peripheral blood) at the time of
             screening

          -  has documented chronic HCV GT1, GT2, GT3, GT4, GT5, or GT6 (with no evidence of
             non-typeable or mixed GT)

          -  is a female who is not of reproductive potential, or is a female of reproductive
             potential who agrees to avoid becoming pregnant from two weeks prior to Day 1 through
             14 days after the last dose of study drug via abstinence or use of two approved
             contraceptives

          -  is C or NC

          -  if coinfected with HIV, has documented HIV infection prior to Day 1, and either does
             not use an antiretroviral therapy (ART) or has well-controlled HIV on stable ART (at
             least 4 weeks prior to study entry)

        Exclusion Criteria:

          -  has evidence of decompensated liver disease

          -  is C and is Child-Pugh Class B or C, or has a Child-Tucotte-Pugh score >6

          -  is coinfected with hepatitis B virus (hepatitis B surface antigen or hepatitis B core
             antibody positive)

          -  is coinfected with HIV and has a recent (within 6 months prior to screening)
             opportunistic infection

          -  has a history of malignancy other than adequately treated basal cell or squamous cell
             skin cancer or in situ cervical cancer or carcinoma in situ within 5 years of signing
             informed consent

          -  is C and has evidence (liver imaging within 6 months prior to Day 1) of hepatocellular
             carcinoma (HCC) or is under evaluation for HCC

          -  has participated in another investigational drug study within 30 days of signing
             informed consent

          -  is a female who is pregnant or breastfeeding or expecting to conceive or donate eggs
             from Day 1 through 6 months after the last dose of study drug or longer if dictated by
             local regulations, or is a male who is expecting to donate sperm from Day 1 through 14
             days after the last dose of study drug or longer if dictated by local regulations, or
             is a male whose female partner(s) is/are pregnant or breastfeeding

          -  has clinically relevant alcohol or drug abuse within 12 months of screening

          -  has any of the following conditions: organ transplants other than cornea and hair;
             poor venous access; history of gastric surgery; clinically significant cardiac
             abnormality/dysfunction; any major medical condition which, in the opinion of the
             investigator, might interfere with participation; hospitalization within 3 months
             prior to enrollment; any condition that might require hospitalization; any condition
             requiring or likely to require chronic systemic administration of corticosteroids,
             tumor necrosis factor (TNF) antagonists, or immunosuppressant drugs; a
             life-threatening SAE during screening; or hepatitis not caused by HCV