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

Launched by ABBVIE · Sep 22, 2014

Keywords

ClinConnect Summary

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).

Gender

ALL

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