A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)

Study Overview
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Brief Summary
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The purpose of the study is to determine if combination therapy with daclatasvir (DCV) and sofosbuvir (SOF) for 8 weeks is safe and effective in patients who have never been treated previously without liver cirrhosis who are chronically infected with hepatitis C virus (HCV)/HIV-1 Coinfection genotype (GT) 1, 2, 3, 4 patients.

Official Title
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A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Daclatasvir
* Drug: Sofosbuvir


Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: HCV RNA < 2000000 IU/mL Never taken medication for HCV No Liver Cirrhosis No advanced fibrosis Body mass index(BMI) 18-40 kg/m^2 Genotype 1-4 Exclusion Criteria: Infection with HCV other than GT-1, 2, 3 or GT-4 or subjects with mixed infections of any genotype Evidence of decompensated liver Subjects Infected with HIV 2 Hepatitis B virus (HBV) coinfection Liver Cirrhosis Advanced fibrosis (F3-F4)

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: Daclatasvir + Sofosbuvir<br>Daclatasvir 30, 60, 90 mg tablet (dose is dependent on cART regimen) + Sofosbuvir 400 mg tablet oral dosing once daily for 8 weeks | Drug: Daclatasvir<br> <br> Drug: Sofosbuvir<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with SVR12 | SVR12 rate defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects infected with HCV/HIV-1 coinfection genotype 1-4 | Post treatment follow-up week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virologic response (SVR12) rate | SVR12 rate defined as HCV RNA < lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects infected with HCV/HIV-1 coinfection, by individual genotype (1-4) | Approximately 2 years | 
| Treatment safety measured by the number of incidence of serious adverse event (SAEs), discontinuations due to adverse event (AEs), Grade 3/4 AEs and Grade 3/4 clinical laboratory abnormalities through the end of treatment |  | Approximately 2 years | 
| Proportion of subjects who achieve HCV RNA < LLOQ-TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, EOT, post-treatment Week 4 in subjects on the 8-week regimen of DCV/SOF |  | Approximately 2 years | 
| Proportion of subjects who achieve HCV RNA < LLOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, end of treatment (EOT), in subjects on the 8-week regimen of DCV/SOF |  | Approximately 2 years | 
| Proportion of subjects receiving cART who maintain HIV virologic suppression |  | Approximately 2 years | 
| Proportion of subjects receiving cART who experience HIV virologic failure |  | Approximately 2 years |