SHS_610042 KOWK CMER 16161

A Phase II, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-3682 + MK-8408 in Subjects With Chronic HCV Genotype 1, 2, 3, 4, 5 or 6 Infection

The study is a multiple-arm investigation of co-administration of 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. The impact of the study treatment regimen on Sustained Virologic Response (SVR)12 (undetectable HCV ribonucleic acid [RNA] 12 weeks after ending study treatment) for each HCV Genotype will be evaluated in cirrhotic participants and non-cirrhotic participants.

Inclusion Criteria:

Hepatitis C Virus (HCV) ribonucleic acid (RNA) at the time of screening
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
Absence of cirrhosis or compensated cirrhosis
Is HCV treatment-naïve or 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 no plans to initiate ART treatment while participating in this study or well-controlled HIV on ART

Exclusion Criteria:

Is mentally or legally incapacitated, significant emotional problems (at screening or expected during the study) or a history of a clinically significant psychiatric disorder that would interfere with the study procedures.
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 a Pugh-Turcotte (CPT) score >6 if cirrhotic
Is co-infected with Hepatitis B Virus
History of opportunistic infection in the preceding 6 months prior to screening if co-infected with HIV
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
Cirrhosis and liver imaging within 6 months prior to study start showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
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
Clinically-relevant drug or alcohol abuse within 12 months of study start
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
Any cardiac abnormalities/dysfunction
History of a medical/surgical condition that resulted in hospitalization within 3 months prior to study start, other than for minor elective procedures
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
Evidence of history of chronic hepatitis not caused by HCV
Phase II
NCT02759315
All Other
Hepatic
Kris Kowdley, M.D.
Merck
  • Swedish Medical Center