Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection

Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics, Safety and Efficacy of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children From 3 to Less Than 18 Years of Age With GT-1 to -6 Chronic Hepatitis C (CHC) Infection

The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Participants monoinfected with HCV genotype -1 to -6
• HCV RNA ≥1,000 IU/mL at Screening
• Participants who are HCV-treatment naïve or treatment experienced
• Participants in Cohort 1 must have a body weight ≥ 45kg at Day 1

Exclusion Criteria:

• Mixed genotype HCV infections
• Evidence of an ongoing medical condition contributing to chronic liver disease other than HCV
• Evidence of cirrhosis, either compensated or decompensated
• Prior exposure to sofosbuvir and/or NS5A inhibitor

Other protocol defined inclusion/exclusion criteria could apply