Abbott ABT today
released details on its phase 3 hepatitis C registrational program following
promising results from its phase 2b clinical trial, known as Aviator,
presented at the Annual Meeting of the American Association for the Study of
Liver Disease (AASLD) in Boston. The phase 3 clinical trials are designed to
evaluate safety and efficacy of a 12-week regimen of three direct acting
antivirals (DAA), with and without ribavirin, for the treatment of HCV in
genotype 1 (GT1) non-cirrhotic, treatment-naïve and treatment-experienced
patients. An additional phase 3 trial will study triple-DAAs, with ribavirin,
in patients with cirrhosis for 12 or 24 weeks.
The phase 3 program, which is currently open for enrollment, will include more
than 2,000 patients with HCV genotype 1, with trial sites in 29 countries. The
DAAs in the studies include ABT-450/r (protease inhibitor and ritonavir),
ABT-267 (NS5A inhibitor) and ABT-333 (non-nucleoside polymerase inhibitor).
Treatment duration will be 12 weeks in non-cirrhotic patients, and 12 or 24
weeks in cirrhotic patients. All patients will be followed for 48 weeks
post-treatment. Co-formulated tablets of ABT-450/r and ABT-267 will be used in
the phase 3 trials.
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in