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Pharmaceuticals / Submissions and Approvals / Research and Development

AbbVie Trumpets Positive Phase III Data for Hepatitis C Candidate

March 5, 2014

AbbVie hopes to shake up the red-hot hepatitis C space with initial results from a Phase III study of its investigational candidate that showed encouraging results.

The Pearl-III study evaluated the Abbott subsidiary’s treatment with and without ribavirin in non-cirrhotic, adult patients with chronic genotype 1b (GT1b) hepatitis C virus new to treatment. AbbVie’s regimen consists of the fixed-dose combination of ABT-450 and the HIV drug ritonavir co-formulated with ABT-267, dosed once daily, and ABT-333, dosed twice daily.

Results from the global, multi-center, randomized, placebo-controlled and double-blind study showed that 99.5 percent of patients achieved virologic response rates with ribavirin, while 99 percent showed response rates without ribavirin, AbbVie said.

There were no relapses during the 12-week treatment period, the drugmaker added.

The drugmaker plans to submit an application for U.S. regulatory approval in the second quarter of this year, advancing a potential new competitor to hepatitis C treatments under development targeting various forms of the deadly virus. — Lena Freund

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