Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Daclatasvir; Drug: Ribavirin; Drug: Sofosbuvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02319031

AI444-326

Details and patient eligibility

About

The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with advanced fibrosis or compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Must have Genotype 3 Chronic HCV
• Must have advanced fibrosis (F3) or compensated cirrhosis (F4)
• HCV RNA Viral load ≥ 10,000 IU/mL
• HCV Treatment naive or treatment-experienced

Exclusion Criteria:

• Non Genotype 3 or mixed genotypes
• Non advanced fibrosis or compensated cirrhosis
• Any prior treatment with NS5A inhibitors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Arm1: Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)

Active Comparator group

Description:

Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing

Treatment:

Drug: Daclatasvir

Drug: Ribavirin

Drug: Sofosbuvir

Arm2 : Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)

Active Comparator group

Description:

Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing

Treatment:

Drug: Daclatasvir

Drug: Ribavirin

Drug: Sofosbuvir