Study to Investigate Tolerability and Efficacy of MK5172 / MK8742 Without Ribavirin for 12 Weeks in Patients With Chronic HCV G1b Infection With Compensated Cirrhosis

Study Overview
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Brief Summary
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To assess efficacy (SVR rate) of MK5172 / MK8742 for 12 weeks without RBV in G1b patients with compensated cirrhosis (Child-Pugh A5 to A6) previously failing first gen. PI or non responders to PR.

Official Title
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A Multicenter, Open Label, Pilot Study to Investigate Tolerability and Efficacy of MK5172 / MK8742 Without Ribavirin for 12 Weeks in Patients With Chronic HCV G1b Infection With Compensated Cirrhosis (Child-Pugh A5 to A6) and No Response to PR or Prior Failure to First Generation Protease Inhibitors (PIs)

Conditions
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Hepatitis C, Compensated Cirrhosis

Intervention / Treatment
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* Drug: MK5172 /MK8742


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent form signed, Age > 18 years, Chronic infection with Hepatitis C virus genotype 1b, HCV RNA > 100 IU/mL, HCV patients previously treated by PR with no response or previously treated with first generation PIs (boceprevir, telaprevir, simeprevir) and failing therapy, Subjects with compensated cirrhosis with Child-Pugh score ranging between A5 to A6. Cirrhosis defined by liver biopsy (METAVIR F4) or non-invasive methods (transient elastography (FibroScan) > 12.5 KPa; or FibroTest or FibroSure > 0.75 with APRI >2), Hepatic Venous Pressure Gradient (HVPG) > 6 mmHg (only in selected sites), Albumin level ≥ 3.0 g/dl, Platelet count ≥ 75 x 103/μL. Exclusion Criteria: Child-Pugh score greater than CP-A6, Patients with HCV genotype 1a, 2, 3, 4, 5, 6, Have any serious or active medical illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance, HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive), Decompensated cirrhosis/previous decompensation, Pregnancy, Breast-feeding, Known hypersensitivity to Grazoprevir, Elbasvir or any of its components, Albumin level < 3.0 g/dl, Platelet count < 75 x 103/μl, Concomitant participation in any clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK5172 /MK8742<br> | Drug: MK5172 /MK8742<br>* tablets of MK-5172 100 mg/MK-8742 50 mg will be administered orally, daily for 12 weeks without ribavirin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virologic response rates 12 weeks after discontinuation of therapy (SVR12). SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. |  | 12 weeks after discontinuation of therapy (SVR12). |