A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)

The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-experienced adults.

Inclusion Criteria:

• Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control.
• Chronic hepatitis C, genotype 1 infection and HCV RNA level greater than 10,000 IU/mL at screening.
• Previous treatment failure of peg-interferon and ribavirin (pegIFN and RBV).
• No evidence of liver cirrhosis.

Exclusion Criteria:

• Positive screen for drugs or alcohol.
• Significant sensitivity to any drug.
• Use of contraindicated medications within 2 weeks of dosing.
• Certain predefined abnormal laboratory tests.
• Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.