DURHAM, N.C., Dec. 21, 2021 (GLOBE NEWSWIRE) — Data from the HIV Prevention Trials Network (HPTN) studies HPTN 083 and HPTN 084 helped provide important information for yesterday’s decision by the U.S. Food and Drug Administration (FDA) to approve ViiV Healthcare’s long-acting cabotegravir (CAB-LA) injections for the prevention of HIV. Sponsored and co-funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), these studies showed that CAB-LA injected once every eight weeks was superior to daily oral tenofovir/emtricitabine (TDF/FTC) for HIV prevention among cisgender men and transgender women who have sex with men (HPTN 083) and cisgender women (HPTN 084). Both studies also demonstrated that CAB-LA was well-tolerated, offering a new and important pre-exposure prophylaxis (PrEP) option for individuals at risk for HIV infection. ViiV Healthcare will market CAB-LA for PrEP under the brand name Apretude.
“This is a truly critical milestone for HIV pre-exposure prophylaxis providing a safe and effective alternative to daily pills,” said Dr. Myron Cohen, HPTN co-principal investigator, and director of the Institute for Global Health at the University of North Carolina in Chapel Hill. “Until we have a cure or vaccine, more prevention options that meet the needs of individuals at risk for HIV around the world are essential.”
HPTN 083 was co-funded by NIAID and ViiV Healthcare. HPTN 084 was co-funded by NIAID, the Bill & Melinda Gates Foundation, and ViiV Healthcare. Study product was provided by ViiV Healthcare and Gilead Sciences, Inc. Three other NIH institutes also collaborated on HPTN 083 and HPTN 084: the National Institute of Mental Health, the National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
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. In the study, 52 HIV infections occurred, with 12 new infections in the CAB arm and 39 new infections in the TDF/FTC arm. These findings translate to a 69 percent reduction in incident HIV infections in study participants given CAB-LA compared to TDF/FTC.
HPTN 084 enrolled 3,223 cisgender women at research sites in Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda, and Zimbabwe. There were three new infections in the CAB arm and 36 new infections in the TDF/FTC arm, a 92 percent reduction in incident HIV infections in study participants given CAB-LA compared to TDF/FTC.
“HIV continues to disproportionately impact specific populations who need new HIV prevention options that are not only convenient but also highly effective,” said Dr. Wafaa El-Sadr, HPTN co-principal investigator, director of ICAP, and professor of epidemiology and medicine at Columbia University in New York. “CAB-LA is a long-awaited and welcomed addition to the HIV prevention toolkit, offering a potentially convenient option for so many around the world.”
About the HPTN
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. The U.S. National Institute of Allergy and Infectious Diseases, the U.S. National Institute of Mental Health, Office of The Director, the U.S. National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, all part of the U.S. National Institutes of Health, co-fund the HPTN. The HPTN has collaborated with more than 85 clinical research sites in 19 countries to evaluate new HIV prevention interventions and strategies in populations with a disproportionate HIV burden. The HPTN research agenda – more than 50 trials ongoing or completed with over 161,000 participants enrolled and evaluated – is focused primarily on discovering new HIV prevention tools and evaluating integrated strategies, including biomedical interventions combined with behavioral risk reduction interventions and structural interventions. For more information, visit hptn.org.
Media inquiries: Eric Miller, +1.919.384.6465; [email protected]