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
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
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