Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

The study was a randomized, double blind, placebo controlled study consisting of 2
substudies. In substudy 1, participants received 1 of 3 doses of ABT-267 or placebo +
pegIFN/RBV for 12 weeks. In substudy 2, participants received pegIFN/RBV for 36 weeks.
Participants were followed for 48 weeks post ABT-267 treatment for evaluation of efficacy and
safety.

Inclusion Criteria:

- Treatment naïve participants

- Females must be either postmenopausal for at least 2 years or surgically sterile

- Males must be surgically sterile or practicing specific forms of birth control

- Chronic hepatitis C virus (HCV), genotype-1 infected participants

- Documented FibroTest score in combination with an Aspartate Aminotransferase to
Platelet Ratio Index (APRI), or a liver biopsy within the last 12 months to document
absence of cirrhosis

Exclusion Criteria:

- Pregnant or breastfeeding female

- Use of any medications contraindicated for use with pegylated interferon(pegIFN) or
ribavirin (RBV) 2 weeks prior to study drug administration or 10 half-lives, whichever
is longer

- Clinically significant cardiac, respiratory (except mild asthma), renal,
gastrointestinal, hematologic, neurologic disease, or any uncontrolled medical illness
or psychiatric disease or disorder

- Current or past clinical evidence of cirrhosis or bridging fibrosis

- Abnormal screening laboratory results