Tuesday, March 6, 2012

More Details Emerge, On Concerns With Victrelis® & HIV Co-Infected


I am tempted to offer the acidic observation that this was dumped into a 9 pm Eastern Super Tuesday results news blizzard -- perhaps in the hope it would be buried under the drama unfolding in Ohio tonight. But I won't.

More seriously, I think this is going to turn into more tough sledding for the legacy Schering-Plough Victrelis® (boceprevir) campaign -- it may never reach 20 percent share in the United States. Vertex will benefit here. From Whitehouse Station, tonight -- do go read it all:

. . . .Merck announced results as part of a late-breaker poster session [Poster #771] from a pharmacokinetic study evaluating drug interactions between VICTRELIS and ritonavir-boosted HIV protease inhibitors in 39 healthy volunteers. In this study, concomitant administration of VICTRELIS with ritonavir (Norvir®) in combination with atazanavir (Reyataz®) or darunavir (Prezista®), or with lopinavir/ritonavir (Kaletra®) resulted in reduced exposures of the HIV medicines and VICTRELIS. These drug interactions may be clinically significant for patients infected with both chronic HCV and HIV by potentially reducing the effectiveness of these medicines when co-administered. Merck does not recommend the co-administration of VICTRELIS and ritonavir-boosted HIV protease inhibitors.

"In light of the differing results in these data sets, Merck recognizes it is important to continue to study VICTRELIS in combination therapy in this difficult-to-treat patient population," said Eliav Barr, M.D., vice president, Project Leadership and Management, Infectious Diseases, Merck Research Laboratories. "Our collaborative studies with the French National Agency for Research on AIDS and Viral Hepatitis2 (ANRS) and the AIDS Clinical Trial Group (ACTG), which is funded by the U.S. National Institute of Allergy and Infectious Diseases, will provide greater insight into the potential role of VICTRELIS in treating patients with chronic HCV genotype 1 infection who are coinfected with HIV-1. . . ."

We first mentioned this a month ago, now. This will blunt the Roche marketing muscle, I guess, as well. Tough break.

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