New results announced today by ViiV healthcare show that injection of long-acting pre-exposure prophylaxis (PrEP) cabotegravir every two months is 89% more effective than a daily Truvada oral pill (emtricitabine/tenofovir disoproxil fumarate) in a trial of women at increased risk of HIV acquisition.
The HPTN 084 (or LIFE) study involved 3,223 women aged 18-45 years in seven African countries (Botswana, Kenya, Malawi, South Africa, eSwatini, Uganda and Zimbabwe).
Linda-Gail Bekker, International AIDS Society Past President, said: “Women now make up more than half of all people living with HIV across the world, and in sub-Saharan Africa, where this study was conducted, they bear a disproportionate burden of the epidemic. This breakthrough increases the options for effective prevention for the populations who are most burdened but often unable to access those opportunities. By reducing reliance on a daily pill, long-acting injectable forms of PrEP would give them more choice and potentially more control over their lives.”
The scheduled interim analysis – conducted part way though the planned study period – led to the project’s independent data and safety monitoring board calling for the trial to be unblinded so that participants can choose between the two prevention options in an open-label fashion.
The investigators noted that long-acting cabotegravir and Truvada tablets were both well tolerated throughout the study. Adherence to oral Truvada was higher than previously observed in similar studies and populations.
HPTN 084 is one of two trials assessing the safety and efficacy of long-acting cabotegravir in preventing HIV transmission. Results from the other trial, HPTN 083, which involves men and transgender women who have sex with men, were announced this July at the 23rd International AIDS Conference (AIDS 2020: Virtual). After enrolling 4,570 participants in Argentina, Brazil, Peru, United States, South Africa, Thailand and Vietnam, HPTN 083 was stopped when interim data showed that long-acting cabotegravir was more effective at preventing HIV than Truvada, as with HPTN 084.
Roger Tatoud, Deputy Director, HIV Programmes and Advocacy, said: “Although we know that daily oral PrEP is highly effective at preventing HIV when taken as prescribed, we are hugely excited by the potential of long-acting injectable for PrEP demonstrated by these studies. The next step is approval by regulators, after which governments will need to work with the sector and communities to ensure that long-acting forms of PrEP are available and work effectively on the ground.”
The IAS hosted Global HIV Vaccine Enterprise congratulates the investigators and heartily thanks the participants in these studies, without whom the research would not have been possible.
More information about the study
HPTN 084 is a Phase 3 double-blind study designed to evaluate the safety and efficacy of long-acting injectable cabotegravir for HIV prevention administered every eight weeks compared with daily oral Truvada in 3,223 women at increased risk of HIV acquisition. It began enrolling participants in November 2017.
For further information on HPTN 084, please see https://clinicaltrials.gov/ct2/show/NCT03164564.
The study was conducted by the HIV Prevention Trials Network (HPTN) and sponsored by NIH’s National Institute of Allergy and Infectious Diseases (NIAID). It was funded by the Bill & Melinda Gates Foundation, NIAID, the NIH’s National Institute of Mental Health and ViiV Healthcare.
For further information on HPTN 083, please see https://clinicaltrials.gov/ct2/show/NCT02720094.