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Novel integrase inhibitor dolutegravir still potent at 96 weeks
Liz Highleyman, 2012-03-09 09:30:00
The next generation integrase inhibitor dolutegravir maintains viral suppression and remains safe after one year of use, according to a small study presented Wednesday at the 19th Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.
HIV integrase inhibitors prevent the virus from inserting its genetic material into host cells. The sole approved drug in this class, raltegravir (Isentress), has demonstrated long-term efficacy, has few interactions, and is among the best-tolerated antiretrovirals, encouraging development of more agents of this type.
Dolutegravir (formerly S/GSK1349572), produced by ViiV/Shionogi, is taken once daily with no need for boosting and no food requirements. Prior studies showed low potential for drug interactions and a distinct resistance profile.
Hans-Jürgen Stellbrink presented the latest data from the Phase 2b SPRING-1 trial (ING112276), a four-arm, dose-ranging study designed to select an optimal dolutegravir dose for Phase 3 trials.
This multinational study included 205 treatment-naive participants. Most (86%) were men, 80% were white, and the median age was 37 years. The average CD4 cell count at baseline was 324 cells/mm3 and one-fifth of patients had high viral load above 100,000 copies/ml.
Participants were randomly assigned to receive dolutegravir at once-daily doses of 10, 25, or 50mg, or else 600mg efavirenz (Sustiva or Stocrin), all in combination with tenofovir and emtricitabine (the drugs in Truvada; 67%) or abacavir and lamivudine (the drugs in Kivexa or Epzicom; 33%).
Findings from an unusual 16-week primary analysis and the typical 48-week analysis were presented at last summer's International AIDS Society conference (IAS 2011) in Rome. To assess longer-term safety and durability of response, researchers continued to follow patients in all arms through 96 weeks. The 50mg does was chosen for Phase 3 studies of treatment-naive people, now enrolling.
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