10 November 2020 – The Desmond Tutu HIV Centre and Health Foundation welcome the announcement that another trial of long-acting injectable antiretroviral cabotegravir has demonstrated safety and efficacy in the prevention of HIV in cisgender women in Africa. Study sponsors ViiV, NIAID and the HPTN announced yesterday that the randomised part of the landmark trial was stopped early by the trial Data & Safety Monitoring Board after results showed cabotegravir to be highly effective in preventing HIV acquisition. The trial also reconfirmed the safety and efficacy of daily oral Truvada but showed that cabotegravir was 89% more effective at preventing HIV than the alternative daily regimen of Tenofovir/Emtracitabine (Truvada).
The Desmond Tutu HIV Centre’s Emavundleni Clinical Research Site in Crossroads Cape Town is a participating research site in the trial, which enrolled 3,223 women aged 18-45 years old who were at risk for acquiring HIV infection. There are 20 participating sites across sub-Saharan Africa.
The evidence that injections of cabotegravir every 2 months are more effective than daily oral Truvada is an exciting milestone in HIV prevention, as long-acting PrEP will increase HIV prevention choices and help those who find a daily regimen challenging.
“This is encouraging and exciting news that increases choice and provides opportunities to overcome some of the barriers we have seen to wholescale adoption of PrEP. It is a big milestone for HIV prevention,” said DTHC deputy director Professor Linda-Gail Bekker.
Dr. Lulu Nair, Clinical Research Site Lead at Emavundleni said “Our participants are our heroines- they have made this possible. We pay tribute to them and the terrific research and site teams in many countries.”
The early study unblinding recommended by the Data Safety and Monitoring Board in this prevention trial for women comes after the announcement earlier this year from the companion study HPTN 083 that established cabotegravir’s efficacy in preventing HIV among cisgender men and transgender women who have sex with men. In both trials, participants will be offered the choice to continue with long-acting cabotegravir or daily PrEP pills depending on preference.
Watch the full study update press briefing below: