A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-333 Alone and in Combination With Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

This was a Phase 2a, blinded, randomized, placebo-controlled clinical trial in hepatitis C
virus (HCV)-infected adults with 2 planned sequential evaluations, Part 1 and Part 2. The
study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of ABT-333
or placebo monotherapy, followed by 26 days of ABT-333 or placebo with pegylated interferon
a-2a (pegIFN) and ribavirin (RBV) combination therapy. Review of safety and efficacy in Part
1 of the study showed similar response rates across ABT-333 doses so Part 2 of the study was
not performed. The study also assessed emergence of resistant HCV in conjunction with
kinetics of viral load decay and rebound in treatment-naïve, HCV-infected participants.

Inclusion Criteria:

- Participant has provided written consent.

- If female, participant is postmenopausal or surgically sterile.

- If male, must be practicing two effective methods of birth control.

- Participant is hepatitis C virus (HCV) genotype 1 with HCV ribonucleic acid levels
>50,000 IU/mL.

- Participants must demonstrate chronic hepatitis C infection for at least 6 months
prior to study enrollment.

- Participants must have a liver biopsy with histology consistent with HCV-induced liver
damage, and with no evidence of cirrhosis or liver pathology due to any cause other
than chronic HCV.

- Condition of general good health other then HCV infection.

- Participants with a history of thyroid disease must have a thyroid stimulating hormone
(TSH) value in the normal range.

Exclusion Criteria:

- No prior history of receiving therapy for HCV infection.

- Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B
surface antigen (HBsAg), or human immunodeficiency virus antibody (HIV Ab).

- Pregnant or breastfeeding females or male partners of women who are pregnant.

- History of seizures or cancer.

- History of major depressive disorder within 2 years.

- Any current or past history of cirrhosis.

- Any cause of liver disease other than chronic HCV infection.