Conditions: Chronic Hepatitis C Infection
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 453
Healthy volunteers: no

Brief summary:
To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1

Detailed description:
Study Classification: Safety/Efficacy and Pharmacokinetics/dynamics

GT=genotype

Arms:
arm 1: Pegylated Interferon Lambda 180 µg solution, injection subcutaneously once weekly for 24 weeks

Ribasphere 200 mg tablets (800 mg per day: two 200 mg tablets in the morning and two 200 mg tablets in the evening) by mouth twice daily for 24 weeks

Daclatasvir 30 mg, 60 mg, or 90 mg tablets (depending on concomitant HIV regimen) once daily for 12 weeks arm 2: Pegylated Interferon Lambda 180 µg solution, injection subcutaneously once weekly for 24 or 48 weeks

Ribasphere 200 mg tablets, (1000 mg per day: two 200 mg tablets in the morning and three 200 mg tablets in the evening for subjects weighing \<75 kg and 1200 mg per day: three 200 mg tablets in morning and three 200 mg tablets in evening for subjects weighing ≥75 kg) by mouth twice daily for 24 or 48 weeks

Daclatasvir 30 mg, 60 mg, or 90 mg tablets (depending on concomitant HIV regimen) once daily for 12 weeks

Interventions: intervention 1: Pegylated Interferon Lambda-1a intervention 2: Daclatasvir (DCV) intervention 3: Ribasphere (RBV)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: