IAVI welcomes evidence of cabotegravir’s safety and efficacy in cisgender men and transgender women who have sex with men.
The HIV Prevention Trials Network (HPTN) today announced that a long-acting form of HIV prevention injected once every eight weeks prevented HIV infection among healthy cisgender men and transgender women who have sex with men. A Phase IIb/III trial known as HPTN 083 randomized volunteers to receive either the injectable drug cabotegravir or the standard-of-care daily oral HIV prevention pill known as Truvada. Upon an interim review of the study data, an independent Data and Safety Monitoring Board (DSMB) recommended that the study results be announced as soon as possible. The blinded phase of the trial has ended, and all study participants who were assigned to receive Truvada will be offered cabotegravir as soon as it is available.
IAVI welcomes evidence of cabotegravir’s safety and efficacy in some key populations as an important step toward expanding the pipeline of globally accessible HIV prevention products. Despite the availability of proven HIV prevention strategies, and increasing use of antiretroviral therapy globally, including as pre-exposure prophylaxis (PrEP), more than 1.7 million new HIV infections occur each year. For this reason, IAVI also looks forward to data from HPTN 084, an ongoing companion study in healthy cisgender women in sub-Saharan Africa, which the DSMB recommended to continue as planned. Young women aged 15-24 years in the region are twice as likely to be living with HIV than men and struggle to adhere to daily oral PrEP in clinical trials. Long-acting injectable forms of PrEP such as cabotegravir could potentially ease some of their access and adherence barriers. Learn more.
IAVI clinical research center partner UVRI-IAVI in Uganda is participating HPTN 084 under the leadership of Dr. Brenda Okech, Director, UVRI-IAVI. To date, more than 3,000 sexually active women in seven African countries have enrolled in the study, which is co-funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH); ViiV Healthcare; and the Bill & Melinda Gates Foundation.
HPTN 083 is a collaboration by NIH, ViiV Healthcare, Gilead Sciences, Inc., and the NIH-funded HPTN. IAVI commends all the dedicated trial participants, sponsors, clinicians, staff, researchers, and scientists on making this promising development possible.
Learn more about the HPTN 083 trial results from our partners and collaborators: