November 29, 2010
In your electronic in-box this AM, this press release from Merck:
... although the treatment regimen that included ISENTRESS once daily enabled more than 80 percent of patients to achieve viral suppression, ISENTRESS once daily did not demonstrate non-inferiority to the treatment regimen that included ISENTRESS twice daily. Merck said that based on the initial results, and following the recommendation of an independent Data Monitoring Committee, Merck will end the study
Raltegravir is of course still a great HIV drug, and its approval in 2007 marked one of the great steps forward in the history of HIV therapeutics.
But is it a once-daily drug? Probably not based on the results of this study, where twice-daily was simply better -- or, to be more statistically precise, once-daily did not demonstrate non-inferiority.
And in an odd recapitulation of the early days of the protease-inhibitor era, the story is quite similar to what happened to indinavir, another Merck antiretroviral:
The major difference, of course, is that even the once-daily raltegravir arm in this study did quite well -- an 83% response is not too shabby.
It's just that today, our standard-of-care for first-line therapy is (wonderfully) high, and the twice-daily treatment arm had an 89% success rate, with the advantage seen in particular in patients with HIV RNA > 100k. The difference in response put the once-daily approach just outside of the protocol-specified criterion for non-inferiority.
Paul Sax is Clinical Director of Infectious Diseases at Brigham and Women's Hospital. His blog HIV and ID Observations is part of Journal Watch, where he is Editor-in-Chief of Journal Watch AIDS Clinical Care.
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