Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C
Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C
The purpose of this study is to determine the effectiveness, safety and tolerability of
 telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated
 interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naïve and treatment-experienced
 Russian participants with genotype 1 chronic hepatitis C.
This is an open-label (all persons know the study drug assignment), multicenter study in
 treatment-naïve (participant did not receive any previous treatment for the treatment of
 hepatitis C) and treatment-experienced (participant did receive previous treatment for
 hepatitis C) Russian participants with genotype 1 chronic hepatitis C. After a screening
 period of approximately 4 weeks, participants will be treated for 12 weeks with telaprevir
 750 mg every 8 hours in combination with Peg-IFN-alfa-2a and RBV followed by 12 or 36 weeks
 of treatment with Peg-IFN-alfa-2a and RBV alone depending on their liver disease status,
 response to previous treatment and individual virologic response during treatment in this
 study. After the treatment period, there is a follow-up phase of at least 12 weeks.
Inclusion Criteria:

 -  Participant has genotype 1 chronic hepatitis C with HCV RNA level >1000 IU/mL

 -  Participant is either treatment-naïve and did not receive any previous treatment with
 any approved or investigational drug or drug regimen for the treatment of hepatitis C,
 or participant is treatment-experienced who did not achieve sustained virologic
 response (SVR) 24 weeks after at least 1 prior course of Peg-IFN/RBV therapy
 (null-responder, partial-responder or viral relapse)

 -  Participant must have documentation of liver biopsy or fibroscan within 2 years before
 the screening visit or agree to have a biopsy or fibroscan within the screening period
 unless histological cirrhosis was demonstrated by a biopsy or fibroscan > 2 years ago
 prior to screening

 -  A female participant of childbearing potential and a nonvasectomized male participant
 who has a female partner of childbearing potential must agree to the use of 2
 effective methods of birth control from screening until 6 months (female participant )
 or 7 months (male participant) after the last dose of RBV

 Exclusion Criteria:

 -  Prior non-responder that is classified as a viral breakthrough participant

 -  Participant is infected or co-infected with HCV of another genotype than genotype 1

 -  Participant has history of decompensated liver disease or shows evidence of
 significant liver disease in addition to hepatitis C

 -  Participant has human immunodeficiency virus (HIV) or hepatitis B virus (HBV)
 co-infection

 -  Participant has active malignant disease or history of malignant disease within the
 past 5 years (with the exception of treated basal cell carcinoma or hepatocellular
 carcinoma