Phase 3 Study of Elvitegravir for HIV-1 Infection

Gilead Sciences announced data from its Phase 3 (Study 145) trial of elvitegravir for the treatment of HIV-1 infection. Study 145 was a double-blind, multicenter, randomized, active-controlled, 96-week trial evaluating the non-inferiority of elvitegravir (n=351) vs. raltegravir (n=351), administered with a ritonavir-boosted protease inhibitor.

After 96 weeks of treatment, 48% of patients receiving ritonavir-boosted elvitegravir achieved and maintained HIV RNA levels (viral load) <50 copies/mL, compared to 45% of patients receiving raltegravir, based on the Time to Loss of Virologic Response algorithm (TLOVR) (95% CI: -4.6% – 9.9%).

Elvitegravir is an integrase inhibitor that interferes with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells.

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