HPTN 083 Study Demonstrates Superiority of Cabotegravir for the Prevention of HIV . Both cabotegravir and oral tenofovir/emtricitabine (TDF/FTC) have high efficacy for pre-exposure prophylaxis (PrEP).
Researchers from the HIV Prevention Trials Network (HPTN) announced today that the HPTN 083 clinical trial showed that a pre-exposure prophylaxis (PrEP) regimen containing long-acting cabotegravir (CAB LA) injected once every 8 weeks was superior to daily oral tenofovir/emtricitabine (TDF/FTC) for HIV prevention among cisgender men and transgender women who have sex with men. The results were reported at the 23rd International AIDS Conference (AIDS 2020: Virtual). HPTN 083 is a randomized, controlled, double-blind study comparing the safety and efficacy of a regimen including CAB LA to daily TDF/FTC at 43 sites around the world.
During a planned review of study data, an independent Data and Safety Monitoring Board (DSMB) recommended that the study results be announced as soon as possible. The study sponsor, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, agreed with this recommendation.
Some people have difficulty with or prefer not to take pills, and an injectable product such as long-acting CAB could be a very important option for them. HPTN 083 showed that both the regimen containing CAB and oral TDF/FTC demonstrated high efficacy for prevention of HIV acquisition in the study, offering people options that best fit their lifestyle
Overall, HPTN 083 enrolled 4,570 cisgender men and transgender women who have sex with men at research sites in Argentina, Brazil, Peru, South Africa, Thailand, the U.S., and Vietnam. Two-thirds of study participants were under 30 years of age, and 12% were transgender women. Half of the participants in the United States identified as Black or African American.
The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community members and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. NIAID, NIMH, Office of The Director, and NIDA, all part of NIH, co-fund the HPTN. Read more.