A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus 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