A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil

An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Treatment-Naïve or Treatment-Experienced Adults in Brazil With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ III)

The purpose of this study is to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs; ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.

Inclusion Criteria:

• Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
• Males must be surgically sterile or agree to practice acceptable forms of birth control
• Chronic hepatitis C virus (HCV) infection at screening
• Fibrosis stage F3 or greater, documented by acceptable tests
• Participants with cirrhosis: Absence of hepatocellular carcinoma (HCC) as indicated by acceptable methods

Exclusion Criteria:

• Women who are pregnant or breastfeeding
• Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibody positive (HIV Ab)
• Use of contraindicated medications within 2 weeks of dosing
• Clinically significant abnormalities or co-morbidities
• History of solid organ transplant
• Abnormal laboratory tests
• Current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation