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By Kelly Young
Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, DFASAM
When administered as monthly injections, cabotegravir and rilpivirine are noninferior to oral daily regimens for maintaining HIV viral suppression, according to a pair of phase 3 trials in the New England Journal of Medicine. The regimen is not FDA approved.
In each trial, researchers randomized about 600 patients with HIV viral suppression (some were relatively new to treatment) to either continue their oral therapy or switch to monthly injections of cabotegravir, an integrase strand-transfer inhibitor, plus rilpivirine, a nonnucleoside reverse-transcriptase inhibitor. At week 48, long-acting therapy was noninferior to oral therapy in terms of the percentage of patients with plasma HIV-1 RNA levels of 50 copies per mL or higher. Patient satisfaction scores were higher with long-acting therapy.
NEJM Journal Watch Infectious Diseases editor Dr. Carlos del Rio comments: "These two industry-funded studies open the era of long-acting antiretrovirals for the treatment of HIV infection. This is a game changer as it will provide an alternative for viral control in people who are unable or unwilling to take daily pills. Where this fits into the armamentarium and how to implement it in the clinic are still important issues that need sorting out."
Comment
LINK(S):
NEJM article on FLAIR trial (Free for 7 days)
NEJM article on ATLAS trial (Free for 7 days)
NEJM editorial (Subscription required)
Background: NEJM Journal Watch Infectious Diseases coverage of earlier study on monthly injectable ART (Your NEJM Journal Watch registration required)