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
HCV, Hepatitis C Infection, Genotype 4
About this trial
This is an interventional treatment trial for HCV focused on measuring Genotype 4, non-responder, treatment experienced, HCV, naive, relapser, hepatitis infection, compensated cirrhosis, hepatitis c, Cirrhosis, Egypt, null responder, partial responder
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Arm A
Arm B
Arm C
ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent [DAA]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.