A Study of Faldaprevir, Ribavirin and TD-6450 in Participants With Genotype 4 Hepatitis C Virus Infection

A study to evaluate the safety and effect of treatment with experimental antiviral drugs in
combination with ribavirin in treatment-naïve participants with genotype 4 hepatitis C
infection. The study will test the safety and effects of this alternative treatment for up
to 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 4 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

- A FibroSure® score ≤ 0.48 and AST:platelet ratio (APRI) ≤ 1 performed during
screening

Exclusion Criteria:

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