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March 6, 2014

99% Cure Rates for AbbVie’s Hep C Combo in Genotype 1b

CROI 2014AbbVie’s investigational triple-combination therapy cured close to 100 percent of people with genotype 1b of hepatitis C virus (HCV) in a large Phase III trial, MedPage Today reports. K. Rajender Reddy, MD, of the University of Pennsylvania presented findings from the PEARL-III trial at the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.

The results position AbbVie in a competitive position against Gilead Sciences’ combination pill of Sovaldi (sofosbuvir) and its investigational drug ledipasvir, which has had similarly stellar results in clinical trials. Gilead filed for approval for that combination therapy on February 19. Some have theorized that AbbVie may attempt to undercut Gilead on price, leading insurers to overlook the raised pill burden of AbbVie’s option if it works as well as Gilead’s therapy.

The AbbVie trial included 419 participants who received 12 weeks, with or without ribavirin, of the so-called “three-D” therapy: the ritonavir-boosted protease inhibitor ABT-450/r (a coformulated pill of the two drugs), the NS5A inhibitor ABT-267 and the non-nucleoside NS5B inhibitor ABT-333.

A total of 99.5 percent of those who took ribavirin and 99 percent of those who did not achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). The researchers concluded that ribavirin offered no treatment advantage.

Of the just three people who did not achieve an SVR12, two were lost to follow-up and one developed a resistance mutation during treatment and experienced virologic failure.

The major adverse side effects were headache, fatigue, itching, nausea and weakness. The rates of the latter two side effects were significantly greater among those taking ribavirin.

To read the MedPage Today story, click here.

Search: AbbVie, three-D, K. Rajender Reddy, University of Pennsylvania, Conference on Retroviruses and Opportunistic Infections, Gilead Sciences, Sovaldi, sofosbuvir, ledipasvir, ritonavir, ABT-450/r, ABR-267, ABT-333.

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