A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously.

Official Title
-----------------
A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-Cirrhotic Subjects Infected With Chronic HCV Genotype 3

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: Daclatasvir
* Drug: Sofosbuvir
* Drug: Ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Genotype 3 HCV RNA < 2000000 IU/mL Never taken HCV medication Absence of advanced fibrosis or cirrhosis Body mass index (BMI) 18-40 kg/m^2 Exclusion Criteria: Infection with HCV other than genotype 3 (GT3); Mixed infections of any genotype Previously taken HCV medication Liver Cirrhosis Evidence of decompensated liver disease HIV/ hepatitis B virus (HBV) coinfection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: Daclatasvir + Sofosbuvir<br>Daclatasvir 60mg tablet and Sofosbuvir 400mg tablet oral dosing once daily for 8 weeks | Drug: Daclatasvir<br> <br> Drug: Sofosbuvir<br> <br> |
| Active Comparator: Daclatasvir + Sofosbuvir + Ribavirin<br>Daclatasvir 60mg tablet + Sofosbuvir 400mg tablet+ Ribavirin 1000-1200mg tablet(weight based dosing) oral dosing split into am and pm once daily for 8 weeks | Drug: Daclatasvir<br> <br> Drug: Sofosbuvir<br> <br> Drug: Ribavirin<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with sustained virologic response (SVR12) treated with Daclatasvir + Sofosbuvir (DCV+SOF) | SVR12 defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects treated with 8 weeks of DCV+SOF therapy or DCV+SOF+RBV therapy | Post Treatment Follow up Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by number of incidence of deaths, serious adverse events (SAE)s, discontinuation due to adverse events (AE)s, Grade 3/4 AEs and Grade 3/4 laboratory abnormalities observed from clinical laboratory testing |  | Approximately 1.5 years | 
| Antiviral activity measured by the proportion of subjects who achieve HCV RNA < lower limit of quantification (LLOQ) - at during and after treatment in each treatment arm |  | Post treatment follow up Week 24 | 
| Proportion of subjects with CC, CT or TT IL28B genotype who achieve SVR12 in each treatment arm |  | Post Treatment Follow up Week 12 |