Efficacy and Safety of Uprifosbuvir (MK-3682) With Ruzasvir (MK-8408) in Adults With Chronic Hepatitis C Genotype 1, 2, 3, 4, 5 or 6 Infection (MK-3682-035)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Uprifosbuvir 450 mg; Ruzasvir 60 mg
Intervention description: 450 mg administered as 3 x 150 mg oral tablets; 60 mg administered as 6 x 10 mg oral capsules
Intervention MeSH terms: Ruzasvir; Uprifosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is an open-label, multi-center trial to evaluate the novel 2-drug regimen of
      uprifosbuvir (MK-3682) 450 mg and ruzasvir (MK-8408) 60 mg in participants with chronic
      hepatitis C virus (HCV) genotype (GT)1, GT2, GT3, GT4, GT5, or GT6 infection. The impact of
      the study treatment regimen on the percentage of participants with undetectable HCV
      ribonucleic acid [RNA] 12 weeks after completing study treatment (SVR12) will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has hepatitis C virus (HCV) ribonucleic acid (RNA) at the time of screening

          -  Has documented chronic HCV genotype (GT)1, GT2, GT3, GT4, GT5, or GT6 with no evidence
             of non-typeable or mixed GT infection

          -  Is otherwise healthy as determined by the medical history, physical examination,
             electrocardiogram (ECG), and clinical laboratory measurements performed at the time of
             screening

          -  Has absence of cirrhosis or has compensated cirrhosis

          -  Is HCV treatment-naïve or has experienced virologic failure after completing a prior
             interferon-containing regimen

          -  Is of non-childbearing potential or agrees to avoid becoming pregnant or impregnating
             a partner beginning at least 2 weeks prior to administration of the initial dose of
             study drug and for 14 days after the last dose of study drug

          -  For human immunodeficiency virus (HIV) co-infected participants: is not currently on
             antiretroviral therapy (ART) and has no plans to initiate ART treatment while
             participating in this study Or has well-controlled HIV on ART

        Exclusion Criteria:

          -  Is mentally or legally incapacitated, has significant emotional problems (at screening
             or expected during the study) or has a history of a clinically significant psychiatric
             disorder that would interfere with the study procedures.

          -  Has evidence of decompensated liver disease manifested by the presence of or history
             of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other
             signs or symptoms of advanced liver disease

          -  Is Child-Pugh Class B or C or has a Pugh-Turcotte (CPT) score >6 if cirrhotic

          -  Is co-infected with Hepatitis B Virus

          -  Has a history of opportunistic infection in the preceding 6 months prior to screening
             if co-infected with HIV

          -  Has a history of malignancy ≤5 years prior to study start (except for adequately
             treated basal cell or squamous cell skin cancer or in situ cervical cancer or
             carcinoma in situ) or is under evaluation for other active or suspected malignancy

          -  Has cirrhosis and liver imaging within 6 months prior to study start showing evidence
             of hepatocellular carcinoma (HCC) or is under evaluation for HCC

          -  Is taking any medications or herbal supplements restricted by the study entry criteria
             in the period from ≤2 weeks prior to study start through 2 weeks after the last dose
             of study drug

          -  Has clinically-relevant drug or alcohol abuse within 12 months of study start

          -  Has participated in any clinical study of an investigational product within 30 days
             prior to the first dose of study drug

          -  Is female and is pregnant or breastfeeding, or expecting to conceive or donate eggs
             from at least 2 weeks prior to study start and 14 days after the last dose of study
             drug

          -  Is male and is expecting to donate sperm from at least 2 weeks prior to Day 1 until 14
             days after the last dose of study drug

          -  Has or has had any of the following: organ transplants (including hematopoietic stem
             cell transplants) other than cornea and hair; poor venous access; history of gastric
             surgery; or history of malabsorption disorders

          -  Has any cardiac abnormalities/dysfunction including but not limited to: unstable
             angina; unstable congestive heart failure; or unstable arrhythmia

          -  Has a history of a medical/surgical condition that resulted in hospitalization within
             3 months prior to study start, other than for minor elective procedures

          -  Has any medical condition requiring, or likely to require, chronic systemic
             administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other
             immunosuppressant drugs during the study

          -  Has evidence of history of chronic hepatitis not caused by HCV