November 9, 2020

Study finds long-acting injectable HIV prevention option is effective for cisgender women

IAVI welcomes evidence of long-acting cabotegravir’s safety and efficacy in cisgender women.

The HIV Prevention Trials Network (HPTN) today announced that a long-acting form of HIV prevention injected once every eight weeks prevented HIV acquisition among cisgender women. A Phase IIb/III trial known as HPTN 084 randomized HIV-negative volunteers to receive either the injectable drug cabotegravir or the standard-of-care daily oral HIV prevention pill known as FTC/TDF, and often called oral PrEP (for pre-exposure prophylaxis). Upon an interim review of the study data, an independent Data and Safety Monitoring Board (DSMB) recommended that the interim study results be announced as soon as possible. Therefore, the blinded phase of the trial has ended, and all study participants who were assigned to receive FTC/TDF will be offered cabotegravir or, if they prefer, can choose to continue taking FTC/TDF until the trial ends.

HPTN 084 enrolled 3,223 cisgender women aged 18-45 years old who were at risk for acquiring HIV in 20 sites across seven countries in sub-Saharan Africa (Botswana, Kenya, Malawi, South Africa, eSwatini, Uganda, and Zimbabwe).

In its announcement about the trial, the World Health Organization noted, “While both methods were highly effective at preventing HIV acquisition, long-acting cabotegravir was 89% (95% CI 68-96%) more effective than FTC/TDF. These results show that [long-acting cabotegravir] is significantly more effective in preventing HIV acquisition than oral PrEP in an intention-to-treat analysis from this trial.”

IAVI welcomes evidence of cabotegravir’s safety and efficacy in cisgender women 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 oral PrEP, more than 1.7 million new HIV infections occur each year[1].

Young women aged 15-24 years in sub-Saharan Africa are twice as likely to be living with HIV than men and struggle to adhere to daily oral PrEP in clinical trials[2]. Long-acting injectable forms of PrEP such as cabotegravir could potentially ease some of their access and adherence barriers.

IAVI clinical research center partner UVRI-IAVI in Uganda is participating in HPTN 084 under the leadership of Dr. Brenda Okech, director, UVRI-IAVI. The study 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, the manufacturer of cabotegravir; and the Bill & Melinda Gates Foundation.

HPTN 084 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 exciting development possible.

Earlier this year, a similar trial (HPTN 083) investigating use of long-acting cabotegravir was also shown to be efficacious in cisgender men and transgender women who have sex with men.

Learn more about the HPTN 084 results from the trial partners and collaborators:

Additional reading

Kundai Chinyenze, Senior Medical Director, IAVI illuminates the challenges and opportunities for women and girls in sub-Saharan Africa in regards to HIV prevention in this STAT op-ed.

[1] UNAIDS Global HIV & AIDS statistics — Fact sheet

[2] STAT: For African women at risk of HIV, a woke world is still sound asleep