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Elvitegravir non-inferior to raltegravir in treatment-experienced patients

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Once-daily elvitegravir was non-inferior to twice-daily raltegravir among treatment-experienced HIV-1–infected patients, researchers reported at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Rome.

“This study is good news for people living with HIV — pending FDA approval they will now have available a new antiretroviral drug that only needs to be taken once-a-day, which in itself will also promote better adherence,” Jean-Michel Molina, MD, PhD, from the Hospital Saint Louis in Paris, said in a press release.

The phase 3, multicenter, randomized, double blind study included 702 adults with plasma HIV-1 RNA loads of at least 1,000 copies/mL and either resistance to or 6 months of experience with more than two classes of antiretroviral therapy. Participants were assigned 150 mg elvitegravir (Gilead Sciences) or 85 mg if administered with atazanavir/ritonavir or lopinavir/ritonavir once per day, or 400 mg raltegravir (Isentress, Merck Sharp & Dohme) twice a day, plus a background regimen of a fully active ritonavir-boosted protease inhibitor and a third agent.

Both regimens resulted in similar efficacy with a virologic response rate of 59% and 58% in the elvitegravir and raltegravir arms, respectively, for a treatment difference of 1.1% (95% CI, –6 to 8.2) in the intent to treat analysis, demonstrating non-inferiority of elvitegravir vs. raltegravir. In addition, safety and resistance profiles were similar, with only 3% to 4% of patients in both arms discontinuing treatment due to adverse events.

For more information:

• Molina JM. #WELBB05. Presented at: The 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention; July 17-20, 2011; Rome.

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