Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects

Phase 2

Completed

• Conditions: Chronic Hepatitis C Infection
• Interventions: Drug: LDV/SOF+ASV; Drug: SOF+DCV+SMV; Drug: SOF+DCV+ASV

• Registration Number: NCT02470858
• Lead Sponsor: Humanity and Health Research Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-06-05
• Study First Submitted QC: 2015-06-09
• Study First Posted: 2015-06-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-26
• Last Update Posted: 2016-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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:

  1. Liver biopsy showing cirrhosis;
  2. Fibroscan showing cirrhosis or results>12.5 kPa ;
  3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LDV/SOF+ASV	LDV/SOF+ASV	Participants with genotype 1b HCV infection will receive LDV/SOF FDC + ASV 3 weeks.
SOF+DCV+SMV	SOF+DCV+SMV	Participants with genotype 1b HCV infection will receive SOF + DCV + SMV for 3 weeks.
SOF+DCV+ASV	SOF+DCV+ASV	Participants with genotype 1b HCV infection will receive SOF + DCV + ASV for 3 weeks

Primary Outcome Measures

Name	Time	Method
Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)	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)	Baseline up to Week 24

Secondary Outcome Measures

Name	Time	Method
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	Viral breakthrough is defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) during treatment, but did not achieve a sustained virologic response (SVR). Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR.

Trial Locations

Locations (1)

Humanity and Health GI and Liver Centre; 🇨🇳 Hong Kong, Hong Kong, China