An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants
An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants
The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics
 (the study of the way a drug enters and leaves the blood and tissues over time), and
 pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different
 doses in combination with two standard therapies commercially available for chronic (lasting
 a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.
This is a Phase 2a, open-label (all people know the identity of the intervention),
 multicenter trial (conducted in more than one center) in participants with chronic genotype 1
 HCV infection. The trial consists of a Screening phase of approximately 4 weeks, a treatment
 phase up to 48 weeks depending on participants' individual virologic response, and a
 follow-up phase of at least 24 weeks. All participants will receive 12 weeks of telaprevir
 treatment in combination with standard therapy. At Week 12, telaprevir dosing will end and
 participants will continue on standard therapy only. Participants will be randomly assigned
 to receive one of the two different dosage regimens of telaprevir (750 milligram [mg] every 8
 hours (hr), or 1125 mg every 12 hr) in combination with standard therapy (pegylated
 interferon [Peg-IFN]-alfa-2a and ribavirin [RBV] or Peg-IFN-alfa-2b and RBV at the standard
 doses). Efficacy will be evaluated by HCV Ribonucleic Acid (RNA) values, viral response,
 viral breakthrough, partial response, early viral kinetics and sustained viral response.
 Pharmacokinetics, Pharmacokinetic-pharmacodynamic relationship will also be evaluated. Safety
 will be monitored throughout the study duration.
Inclusion Criteria:

 -  Chronic genotype 1 Hepatitis (inflammation of the liver) C infection

 -  Never been treated for Hepatitis C Viral (HCV) infection

 -  No clinically significant lab abnormalities

 -  Amount of HCV Ribonucleic acid (RNA) in the blood more than 10,000 international
 units/milliliter (IU/mL) at entry

 -  Liver biopsy or "Fibroscan" test performed during screening or in the past 3 years

 Exclusion Criteria:

 -  Contra-indications for starting anti-HCV therapy

 -  History or evidence of liver cirrhosis (serious liver disorder in which connective
 tissue replaces normal liver tissue, and liver failure often occurs) or decompensated
 liver disease

 -  Any evidence of significant liver disease in addition to Hepatitis C

 -  Infected with Human Immunodeficiency Virus (a life-threatening infection which you can
 get from an infected person's blood or from having sex with an infected person) or
 Hepatitis B

 -  Women who are pregnant (carrying an unborn baby), planning to be pregnant or
 breastfeeding or the partner of a woman who is pregnant or breastfeeding