18 MAY 2020 – The HIV Prevention Trials Network (HPTN) announced results from HPTN 083, a global randomized, controlled, double-blind study that compared the safety and efficacy of long-acting injectable cabotegravir (CAB LA) to daily oral tenofovir/emtricitabine (TDF/FTC) (Truvada) for pre-exposure prophylaxis (PrEP).
The study showed that CAB LA lowered HIV incidence among cisgender men and transgender women who have sex with men. During a planned interim 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.
The Desmond Tutu HIV Centre Clinical Trials Unit at Groote Schuur Hospital is a participating research site, and the only African site, in the global trial, which overall enrolled 4,570 participants. The development of a safe and effective long-acting PrEP will increase HIV prevention choices and help those who find taking a daily pill challenging.
The evidence that 2 monthly injections of cabotegravir is as effective as daily oral Truvada for these populations is therefore an exciting milestone in HIV prevention. Based on the recommendation by the DSMB, participants will now be unblinded and continued on study PreP for the remainder of the initial, intended study period.
HPTN 084, another prevention trial, is comparing the efficacy and safety of CAB LA to daily oral TDF/FTC for PrEP among women in sub-Saharan Africa. This study, of which the DTHC is a research site, is ongoing at this time and we eagerly await results of that trial in the future.
Read more the HPTN Press Release here.