Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotype 3 infection.

Official Title
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Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 3 Infection

Conditions
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Chronic Hepatitis C Infection

Intervention / Treatment
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* Drug: sofosbuvir and daclatasvir
* Drug: ledipasvir/sofosbuvir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age equal to or greater than 18 years, with chronic genotype 3 HCV infection; Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen; HCV RNA > 10,000 IU/mL at Screening; Screening laboratory values within defined thresholds; Negative pregnancy test at baseline (females of childbearing potential only); Use of two effective contraception methods if female of childbearing potential or sexually active male. Exclusion Criteria: Pregnant or nursing female; HIV infection or HBV infection (HBcAb and HBsAg positive); 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).

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sofosbuvir and Daclatasvir<br>Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks. | Drug: sofosbuvir and daclatasvir<br>* Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60 mg tablet administered orally once daily.<br>* Other names: BMS-790052;|
| Active Comparator: Ledipasvir/sofosbuvir<br>Participants will receive Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet daily for 12 weeks. | Drug: ledipasvir/sofosbuvir<br>* Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally. once daily;<br>* Other names: PSI-7977;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy | SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ < 25 IU/mL) 12 weeks following the last dose of study medication | Post treatment Week 12 | 
| Incidence of adverse events leading to permanent discontinuation of study drug |  | Baseline up to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment |  | Baseline up to Week 12 | 
| HCV RNA levels and change during and after treatment |  | Baseline up to Week 12 | 
| Treatment adherence | To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation) | Baseline to Week 12 | 
| Change in health related quality of life | To evaluate the change in health-related quality of life during treatment | Baseline to Week 24 |