A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults
The purpose of this study is to evaluate the safety and antiviral activity of 3 direct-acting
 antiviral agents (DAAs; ABT-450/ritonavir/ABT-267 [ABT-450/r/ABT-267; ABT-267 also known as
 ombitasvir] and ABT-333 [also known as dasabuvir]) plus ribavirin (RBV) compared with
 telaprevir (TPV) with pegylated interferon/ribavirin (pegIFN/RBV) in patients with chronic
 hepatitis C virus genotype 1 (HCV GT1) infection without cirrhosis who were previously
 treated with pegylated interferon/ribavirin (pegIFN/RBV).
A randomized, open-label, parallel-arm, multicenter study to evaluate the safety and
 antiviral activity of the 3-DAA regimen (ABT-450/ritonavir/ABT-267 [ABT-450/r/ABT-267] and
 ABT-333) plus ribavirin (3-DAA/RBV) compared with the combination of telaprevir (TPV) with
 RBV and pegIFN (TPV/RBV) in noncirrhotic participants with chronic hepatitis C virus genotype
 1 (HCV GT1) infection who were previously treated with pegylated interferon/ribavirin
 (pegIFN/RBV).

 Participants were randomized in a 2:1 ratio to receive 3-DAA/RBV (ABT-450/r/ABT-267 and
 ABT-333 plus RBV for 12 weeks) or TPV/RBV (TPV co-administered with pegIFN and RBV for 12
 weeks, followed by followed by pegIFN and RBV for either 12 or 36 weeks, per local
 prescribing information).
Inclusion Criteria:

 -  Females must be practicing specific forms of birth control on study treatment, or be
 post-menopausal for more than 2 years or surgically sterile

 -  Chronic hepatitis C infection (positive for anti-HCV antibody or HCV RNA at least 6
 months before screening and at the time of screening; or positive for anti-HCV
 antibody or HCV RNA at the time of screening with a liver biopsy consistent with
 chronic HCV infection)

 -  Screening laboratory result indicating HCV genotype 1 infection (HCV GT1)

 -  Participant must have documentation of adherence to a prior pegIFN/RBV combination
 therapy and meet one of the protocol definitions for treatment failure: null
 responder, partial responder, relapser

 -  No evidence of liver cirrhosis

 Exclusion Criteria:

 -  Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody

 -  Positive screen for drugs or alcohol

 -  Significant sensitivity to any drug

 -  Use of contraindicated medications within 2 weeks of dosing

 -  Abnormal laboratory tests