Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt
Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt
This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive
 and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.
Non-cirrhotic subjects were directly enrolled into Arm A. Cirrhotic subjects were randomized
 to either Arm B (12 weeks of treatment) or Arm C (24 weeks of treatment).
Inclusion Criteria:

 -  Chronic hepatitis C, genotype 4-infection (hepatitis C virus [HCV] ribonucleic acid
 [RNA] level greater than 1,000 IU/mL at Screening)

 -  Subjects must meet one of the following:

 -  Treatment-naive: Subject has never received antiviral treatment for HCV infection
 OR

 -  Treatment Experienced (Prior null responders, Partial responders or Relapsers to
 pegylated-interferon [pegIFN]/RBV);

 -  Females must be post-menopausal, of non-child bearing potential or practicing specific
 forms of birth control

 -  In substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or
 Fibroscan

 -  In substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan
 with Child-Pugh score less than or equal to 6 at Screening and confirmed absence of
 hepatocellular carcinoma

 Exclusion Criteria:

 -  Females who are pregnant or breastfeeding

 -  Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus
 antibody

 -  HCV genotype performed during screening indicating unable to genotype or co-infection
 with any other HCV genotype

 -  abnormal laboratory tests

 -  self-reports current drinking more than 2 drinks per day

 -  current enrollment in another investigational study

 -  previous treatment with a direct acting antiviral agent (DAA) containing regimen

 -  In substudy 1, evidence of liver cirrhosis

 -  In substudy 2, evidence of current or past Child-Pugh B or C classification and
 confirmed presence of hepatocellular carcinoma