Results could lead to improved prevention options, especially for at-risk populations
Dr. Raphael LandovitzIn the preliminary findings of a global study, the long-acting antiretroviral cabotegravir (CAB-LA) used as pre-exposure prophylaxis against HIV infection was safe and at least as protective as the current standard of care, daily oral TDF/FTC, known by the brand name Truvada.
The clinical trial HPTN 083, which was conducted by the HIV Prevention Trials Network (HPTN) with funding from the U.S. National Institute for Allergy and Infectious Diseases and ViiV Healthcare, enrolled more than 4,500 cisgender men and transgender women who have sex with men across four continents.
After a scheduled review of the randomized, controlled, double-blind study, an independent Data and Safety Monitoring Board (DSMB) found that bimonthly injections of CAB-LA provided significant protection against HIV. The DSMB recommended ending the study early and announcing the results.
“The interpretation of this finding is that cabotegravir was highly effective for HIV prevention.”
“We observed roughly three times the number of incident HIV infections in the Truvada arm than we did in the cabotegravir arm,” said trial protocol chair Dr. Raphael Landovitz, of the David Geffen School of Medicine at the University of California, Los Angeles, at a press briefing on May 18. “The interpretation of this finding is that cabotegravir was highly effective for HIV prevention.”
Two-thirds of study participants were under 30 years old and half of the participants in the U.S. identified as black or African American—both are understudied key populations at risk of HIV acquisition. In an ongoing companion study, HPTN 084, investigators are studying the safety and efficacy of CAB-LA for preventing HIV in cisgender women in sub-Saharan Africa.
Read amfAR’s series of reports on the critical issues that must be navigated as long-acting antiretrovirals begin to advance toward the market.