Effect of Triple Direct Acting Antiviral Agents (DAAs) for Non-cirrhotic Subjects With Chronic HCV G1b Infection
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
Study Overview
Brief Summary
The study is designed to test the hypothesis that the addition of a protease inhibitor to dual NS5a-NS5B nucleoside prodrug analog will enhance antiviral efficacy and hence shorten the treatment duration to 3 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age equal to or greater than 18 years, with chronic genotype 1b HCV infection;
- •HCV RNA level > 10,000 and < 10,000,000 IU/ml at Screening;
- •Rapid response to triple DAAs therapy with less than 500 IU/ml plasma HCV RNA level at Day 2;
- •No evidence of cirrhosis. Cirrhosis defined as any 1 of the following, within 6 months of study entry:
- •Liver biopsy showing cirrhosis;
- •Fibroscan showing cirrhosis or results>12.5 kPa ;
- •FibroTest® score >0.75 and an aspartate aminotransferase (AST): platelet ratio index (APRI) >2 during screening.
Exclusion Criteria
- •Pregnant or nursing female or male with pregnant female partner;
- •HIV or chronic hepatitis B virus (HBV) infection;
- •Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
- •Active or recent history (≤ 1 year) of drug or alcohol abuse;
- •Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers);
- •History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
Arms & Interventions
LDV/SOF+ASV
Participants with genotype 1b HCV infection will receive LDV/SOF FDC + ASV 3 weeks.
Intervention: LDV/SOF+ASV (Drug)
SOF+DCV+SMV
Participants with genotype 1b HCV infection will receive SOF + DCV + SMV for 3 weeks.
Intervention: SOF+DCV+SMV (Drug)
SOF+DCV+ASV
Participants with genotype 1b HCV infection will receive SOF + DCV + ASV for 3 weeks
Intervention: SOF+DCV+ASV (Drug)
Outcomes
Primary Outcomes
Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
Time Frame: Post treatment Week 12
SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.
Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
Time Frame: Baseline up to Week 24
Secondary Outcomes
- Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment.(Baseline up to Week 24)
- HCV RNA levels and change during and after treatment.(Baseline up to Week 24)
- Proportion of participants with on-treatment virologic breakthrough and relapse(Baseline up to Week 24)