Promising Results for New, Simpler Dosing of Raltegravir (Isentress)
April 5, 2016
Although not presented at the 2016 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, a press release was released near the start of CROI about a phase 3 study of the integrase inhibitor, raltegravir (Isentress). The study, called ONCEMRK, compared a new once-a-day dosing of raltegravir to the current twice-a-day dosing schedule. This simplification could help individuals improve adherence to their regimens which may result in better suppression of HIV over time.
The planned 96-week study enrolled people who hadn't been on HIV treatment before and assigned them to take one of two different regimens: take raltegravir once a day as two 600mg tablets (1,200mg total) or take one 400mg tablet raltegravir twice a day (800mg total), which is the current FDA approved dosing schedule. Everyone also took Truvada (emtricitabine/tenofovir TDF).
Through 48-weeks, the once-a-day dosing showed equal suppression of HIV in both groups. However, specific details of the results -- such as percentage of people who were undetectable <50 copies HIV RNA, CD4 count changes and side effects -- were not provided in the press release. Detailed findings are expected to be announced later in the year at another conference.
This study differs from another study of raltegravir several years ago that then showed once-a-day dosing did not suppress HIV as well. However, that earlier study only used the 400mg tablet ... either one 400mg tablet twice a day or two 400mg tablets once a day: a total of 800mg per day for either dosing schedule. ONCEMRK is now using a higher milligram version of raltegravir at a 600mg dose for a total of 1,200mg per day.
Press release, "Merck Announces Isentress Phase 3 Met Primary Efficacy Endpoint in HIV-1", February 22, 2016.
This article was provided by Project Inform. It is a part of the publication The 23rd Conference on Retroviruses and Opportunistic Infections. Visit Project Inform's website to find out more about their activities, publications and services.
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