Hepatitis C Virus (HCV) Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection
This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in non-cirrhotic chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with or without human immunodeficiency virus (HIV) co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN) with or without ribavirin (RBV), OR sofosbuvir with RBV with or without IFN.
Randomization was stratified by geographic region (China, South Korea, Singapore), genotype
(GT1, GT2, combined GT3 - 6), and HCV/HIV co-infection status (co-infected, not co-infected).
In China, eligible participants were randomized to Arm A or Arm B (defined below) in the
following ratios: 2:1 for GT1, 2:1 for GT2, and 2:1 for combined GT3-6. In South Korea and
Singapore, eligible participants were randomized to Arm A or Arm B in the following ratios:
2:1 for GT1 and 2:1 for GT2.
All Primary and Secondary Outcome Measures were pre-specified to be analyzed only in Arm A.
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