Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined
 with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis
 C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.
For more information regarding BMS clinical trial participation, please visit
 www.BMSStudyConnect.com.

 Inclusion Criteria:

 -  Chronic hepatitis C genotype 1. GT-1b Capped at 50 % of naïve subjects

 -  Naives to prior anti-HCV therapy [Interferon (IFN) and direct antiviral agent (DAA)
 based]

 -  Relapsers (defined as subjects who had undetectable HCV ribonucleic acid (RNA) on
 prior treatment regimen of alfa-2a/RBV and Hepatitis C Virus (HCV) RNA > 25IU/mL after
 discontinuation of treatment). Capped at 20%

 -  HCV RNA ≥ 100,000 IU/mL

 -  Subjects with compensated cirrhosis can be enrolled and will be capped at
 approximately 10%

 -  Seronegative for human immunodeficiency virus (HIV) and hepatitis B surface antigen
 (HBsAg)

 -  Men or women, 18-70 years of age

 Exclusion Criteria:

 -  Chronic liver disease due to causes other than chronic HCV

 -  Current or past evidence of decompensation

 -  Conditions that preclude the use of Alfa/RBV/TVR per respective labels

 -  Diagnosed or suspected hepatocellular carcinoma