Injectable PrEP Trial: One Injection Every Eight Weeks

A large Phase III trial of a long-acting injectable form of the innovative antiretroviral cabotegravir for use as pre-exposure prophylaxis (PrEP) against HIV has been started by a collaboration between Gilead Sciences, HIV Prevention Trials Network, ViiV Healthcare and National Institute of Allergy and Infectious Diseases.

The randomised, double-blind HPTN 083 trial will enrol 4,500 HIV-negative cisgender men who have sex with men and transgender women. The trial, to be conducted at 45 sites in eight countries in the Africa, Asia, North and South America, will discover whether long-acting cabotegravir injected every eight weeks protects against HIV as well as daily oral Truvada (tenofovir disoproxil fumarate/emtricitabine) among the high-risk participants.

The study members will be randomly assigned to receive one drug or the other and will remain in the trial for an average of four and a half years. Results are expected in 2021. Another study, HPTN 084, will test the safety and efficacy of long-acting injectable cabotegravir as PrEP among young women in sub-Saharan Africa starting this year.

The research is a collaboration of Gilead Sciences, HIV Prevention Trials Network, ViiV Healthcare, National Institute of Allergy and Infectious Diseases.