efficacy and safety of uprifosbuvir (mk-3682) + ruzasvir (mk-8408) in treating hepatitis c virus infection genotypes 1-6 (mk-3682-041)

Conditions: Hepatitis C

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.

any gt that meets virologic futility criteria will be given the option of extending treatment with uprifosbuvir + rzr to 16 weeks with ribavirin (rbv) added.

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