Long-acting cabotegravir, rilpivirine noninferior in HIV-1

(HealthDay)—For patients with HIV-1 suppression, long-acting cabotegravir plus rilpivirine is noninferior to oral therapy with dolutegravir-abacavir-lamivudine and standard oral therapy, according to two studies published online March 4 in the New England Journal of Medicine.

Chloe Orkin, M.D., from the Queen Mary University of London, and colleagues conducted a phase 3 randomized trial involving adults with HIV-1 infection who were given 20 weeks of daily oral induction therapy with dolutegravir-abacavir-lamivudine. Participants with an HIV-1 RNA level of less than 50 copies/mL were randomly assigned to either continue current oral therapy or switch to oral cabotegravir plus rilpivirine for one month followed by long-acting cabotegravir plus rilpivirine. The researchers found an HIV-1 RNA level of 50 copies/mL or higher in 2.1 and 2.5 percent of patients who received long-acting and oral therapy, respectively, at 48 weeks (adjusted difference, −0.4 percent; 95 percent confidence interval, −2.8 to 2.1), which met the criterion for noninferiority for the primary end point.

Susan Swindells, M.B., B.S., from the University of Nebraska Medical Center in Omaha, and colleagues randomly assigned patients with plasma HIV-1 RNA levels of less than 50 copies/mL for at least six months while on standard antiretroviral therapy to either continue therapy or switch to monthly intramuscular injections of long-acting cabotegravir and long-acting rilpivirine (308 patients per group) in a phase 3 trial. The researchers found HIV-1 RNA levels of 50 copies/mL or higher in 1.6 and 1.0 percent of patients receiving long-acting and oral therapy, respectively (adjusted difference, 0.6 percent; 95 percent confidence interval, −1.2 to 2.5), which met the criterion for noninferiority for the primary end point.

"The ATLAS and FLAIR trials are important milestones in the development of HIV therapeutics and represent major steps into the era of long-acting ART," writes the author of an accompanying editorial.

The study was funded by Viiv Healthcare and Janssen, which manufacture cabotegravir and rilpivirine, respectively.

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