Chronic Hepatitis C Infection Clinical Trial
Official title:
A Randomized, Open-Labeled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered With Ribavirin Compared to Telaprevir Co-administered With Pegylated Interferon a-2a and Ribavirin in Treatment-Experienced Adults With Chronic Hepatitis C Genotype 1 Virus Infection (MALACHITE-II)
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).
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