Hepatitis C (AI452021): A phase 3 evaluation of daclatasvir in combination with peginterferon lambda-1a and ribavirin (RBV) or telaprevir in combination with peginterferon alfa-2a and RBV in patients with chronic hepatitis C genotype 1b who are treatment naïve or prior relapsers to alfa/RBV therapy (1_PRO00000692)
Participants will be randomized to 1 of 2 study medication groups: Lambda + ribavirin + daclatasvir (Group 1) or alfa + ribavirin + telaprevir (Group 2). There will be twice as many participants assigned to Group 1. Both the lambda and the alfa medications are self-injected under the skin once a week; all other medications are taken by mouth. Blood samples will be taken periodically to test immune system response. Duration of the study is expected to be 48 to 72 weeks, including post-treatment follow-up. There is also an optional pharmacogenetic (study of genes) sub-study where, if participants agree, they will provide an additional blood sample and health information. Participants can take part in the main study without taking part in the pharmacogenetic sub-study.
Eligibility
Inclusion Criteria
Age of 18 years or older
Documented chronic infection with HCV GT-1b
Appropriate blood levels
No prior treatment, or documented relapse after prior treatment, with alpha/RBV
Cannot be pregnant or breastfeeding
Must use 2 highly effective methods of contraception for study duration and up to 24 weeks after last dose of study drugs or RBV