A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether 24 weeks of Daclatasvir and Sofosbuvir with Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients with liver cirrhosis.

Official Title
-----------------
A Phase 3 Evaluation of Daclatasvir and Sofosbuvir With Ribavirin in Cirrhotic Subjects With Genotype 3 Chronic Hepatitis C Infection

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

Intervention / Treatment
-----------------
* Drug: DCV
* Drug: SOF
* Drug: RBV


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Genotype 3 HCV HCV RNA ≥10000 IU (International Unit)/mL Compensated Liver Cirrhosis BMI 18-40 kg/m2 Previously treated for HCV or never treated for HCV Exclusion Criteria: Infection with HCV other than Genotype 3. Mixed infection of any genotype Evidence of decompensated liver disease Previous exposure to NS5A inhibitors Other protocol defined inclusion/exclusion criteria could apply

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)<br>Oral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks. | Drug: DCV<br> <br> Drug: SOF<br> <br> Drug: RBV<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virologic Response (SVR12) | SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieve SVR12 in the Presence and Absence of Baseline NS5A (Non-structural Protein 5A) Resistance-associated Polymorphisms | SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach. | Week 12 (Follow-up period) | 
| Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24 | HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria. SVR12 is based on Next Value Carried Backwards approach. | At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment (24 weeks), Follow Up Week 4 (28 weeks), Follow Up Week 12 (36 weeks), Follow Up Week 24 (48 weeks) | 
| Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24 | HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria. | At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment, Follow Up Week 4, Follow Up Week 12, Follow Up Week 24 |