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March 10, 2014

High HCV Cure Rates for BMS Set Stage for Triple Combo Pill

CROI 2014Twelve weeks of Bristol-Myers Squibb’s daclatasvir, asunaprevir and BMS-791325 (’325) cured more than nine out of 10 treatment-naive people with genotype 1 of hepatitis C virus in a recent study, MedPage Today reports. The results open the door for research of a triple-drug combination pill. Results from the randomized, Phase IIb open-label trial were presented at the Conference on Retroviruses and Opportunistic Infections (CROI).

The trial was divided into two groups of participants who received 12 weeks of the NS5A inhibitor daclatasvir, the protease inhibitor asunaprevir and the non-nucleoside ’325. In one group of 80 people, ’325 was dosed at 75 milligrams twice a day, and in another group of 86 people, the drug’s dose was doubled.

Two people discontinued therapy because of adverse side effects. Eleven people experienced virologic failure. The investigators concluded that the only factor that made virologic failure more likely was having genotype 1a of the virus rather than 1b.

Out of the participants for whom the researchers had final data, 92.2 percent (71 out of 77) of those taking the lower dose of ’325 achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure) and 91.7 percent (77/84) of those receiving the higher dose achieved an SVR12.

The investigators found that the results of the trial supported the UNITY 1 and UNITY 2 Phase III trials of a twice-daily fixed dose combination pill of all three drugs, with ’325 at the lower dose.

To read the MedPage Today story, click here.

Search: Bristol Myers Squibb, daclatasvir, asunaprevir, BMS-791325, Conference on Retroviruses and Opportunistic Infections, CROI, UNITY 1, UNITY 2, hepatitis C

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