A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection
A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection
Phase 2 study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir
 and TD-6450 alone or in combination with other antivirals for a 12-week treatment duration in
 treatment-naïve participants with genotype 1b hepatitis C virus (HCV) infection.
A study to evaluate the safety and effect of treatment with experimental antiviral drugs
 alone or in combination with ribavirin in treatment-naïve participants with genotype 1b
 hepatitis C infection. The study will test the safety and anti-viral activity of two regimens
 administered for a duration of 12 weeks. Secondary objectives of this study are to determine
 the pharmacokinetics of the study drugs when co-administered, and to evaluate HCV RNA
 kinetics during treatment.
Inclusion Criteria:

 -  Chronic genotype 1b hepatitis C infection and HCV RNA ≥ 10^4 IU/mL at screening

 -  Hepatitis C virus treatment naive, defined as defined as having never received a
 direct acting anti-viral (DAA), and as having received ≤ 8 weeks of interferon ≥ 6
 months prior to screening

 -  Absence of cirrhosis as defined by one of the following:

 -  A liver biopsy performed within 24 calendar months of Day 1 showing absence of
 cirrhosis

 -  Transient elastography (FibroScan®) performed within 12 calendar months of Day 1
 with a result of ≤ 12.5 kPa (kilopascals)

 -  A non-invasive test measuring liver scarring (FibroSure®) score ≤ 0.48 and AST
 (aspartate aminotransferase):platelet ratio (APRI) ≤ 1 performed during screening

 Exclusion Criteria:

 -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus, HIV-1 or HIV-2