DURHAM, N.C. – Researchers from the HIV Prevention Trials Network (HPTN) presented updated results from the HPTN 084 long-acting cabotegravir (CAB) for pre-exposure prophylaxis (PrEP) study at the AIDS 2022 conference in Montreal. New findings show reductions in HIV incidence were sustained in the 12 months following trial unblinding (November 5, 2020, through November 5, 2021).
“These results are encouraging as CAB efficacy was sustained during the 12 months following unblinding, confirming a high level of protection against HIV acquisition among study participants assigned female at birth,” said Dr. Sinead Delany-Moretlwe, HPTN 084 protocol chair, director of research at Wits RHI, and research professor at the University of the Witwatersrand in Johannesburg, South Africa.
HPTN 084 is an ongoing Phase 3 randomized, controlled trial that previously demonstrated the superiority of ViiV Healthcare’s long-acting cabotegravir compared to daily oral tenofovir/emtricitabine (TDF/FTC) for HIV prevention in individuals assigned female at birth. The blinded portion of the trial was stopped at a planned interim review in November 2020 due to evidence of superior efficacy when compared to daily oral TDF/FTC. Participants were subsequently unblinded and continued their original randomized study regimen pending a protocol amendment to offer open-label CAB.
“HIV infection continues to threaten the health of women worldwide,” 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. “Empowering women with safe and effective PrEP options is critical to reduce HIV as a global health threat.”
HPTN 084 enrolled 3,223 cisgender women at research sites in Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda, and Zimbabwe. Twenty-three incident infections (3 CAB, 20 TDF/FTC) were detected in the 12-month unblinded period. Of these, two (1 CAB, 1 TDF/FTC) were determined to have occurred during the blinded phase. Only one of the CAB cases (blinded phase case) had ever received an injection. An additional 83 confirmed pregnancies (43 CAB, 40 TDF/FTC) occurred in the unblinded period. No congenital anomalies were reported.
“The additional pregnancy incidence data highlight the importance of establishing the safety and pharmacology of CAB among pregnant individuals,” said Dr. Wafaa El-Sadr, HPTN co-principal investigator, director of ICAP, and professor of epidemiology and medicine at Columbia University in New York.
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 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.
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.