Long-acting injection superior to daily oral HIV PrEP in cisgender women
A long-acting injection of cabotegravir given every 8 weeks was 89% more effective than oral emtricitabine/tenofovir disoproxil fumarate in preventing HIV among cisgender women, according to data released by ViiV Healthcare.
According to ViiV, an independent data safety monitoring board recommended the early unblinding of results from the HIV Prevention Trials Network (HPTN) 084 study after an interim analysis showed the long-acting injection was superior to daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).
Results from a companion trial, HPTN 083, previously showed that long-acting cabotegravir was superior to FTC/TDF among transgender women and cisgender men who have sex with men.
“It’s thrilling to collaborate with the NIH and the Bill & Melinda Gates Foundation to conduct such an important study in HIV prevention in women and deliver groundbreaking results confirming the superior efficacy of long-acting cabotegravir for PrEP,” Kimberly Smith, MD, MPH, head of research and development at ViiV Healthcare, said in a press release. “Women need more effective choices for HIV prevention.”
If approved, long-acting cabotegravir will provide an option that reduces the number of annual dosing days from 365 to 6, Smith noted. Additionally, Smith said that long-acting cabotegravir can be discretely administered and may empower women to reduce their risk for HIV acquisition without the need to negotiate with their sexual partner.
HPTN 084 enrolled 3,223 women from 20 sites in seven countries in sub-Saharan Africa. Ultimately, the study demonstrated that there was “a statistically significant advantage” for the women who received cabotegravir compared with the women who took daily FTC/TDF, although both were highly effective at preventing HIV in the study population. In total, 38 women in the trial acquired HIV four assigned to cabotegravir arm and 34 in the FTC/TDF arm, translating to an HIV incidence rate of 0.21% (95% CI, 0.06%-0.54%) in the cabotegravir group and 1.79% (95% CI, 1.24%-2.51%) in the FTC/TDF group.
Through these results, researchers determined that long-acting cabotegravir was 89% (95% CI, 68%-96%) more effective than FTC/TDF.
“Young women may be twice as likely to acquire HIV as their male counterparts in certain regions around the world, making new HIV prevention options an important unmet need. It’s for this reason particularly that participants from sub-Saharan Africa were chosen for the HPTN 084 study, as women in this region bear a disproportionate burden of the HIV epidemic,” Sinead Delany-Moretlwe, MBBCh, PhD, DTM&H, HPTN 084 protocol chair and research director at Wits RHI at the University of the Witwatersrand in Johannesburg, South Africa, said in the press release. “To see such incredible results among these women most at risk is exciting and speaks to the potential of long-acting cabotegravir as a new HIV prevention option.”
Additionally, the study showed that long-acting cabotegravir and FTC/TDF were both well tolerated. According to the press release, most adverse events were mild or moderate in severity and were balanced between both treatment arms.
“With the combined landmark findings of HPTN 084 announced today and HPTN 083 announced earlier this year, we’ve confirmed that long-acting cabotegravir is a superior HIV prevention option for men and women,” Myron S. Cohen, MD, co-principal investigator of HPTN and Yeargan-Bate Distinguished Professor of Medicine, Microbiology and Immunology and Epidemiology at the University of North Carolina at Chapel Hill, said in the press release. “New HIV prevention agents that address the many needs of all individuals at risk for acquiring HIV are essential pillars of our strategy to end the HIV epidemic. If approved, this innovative new injectable option administered once every 2 months will expand the way we approach HIV prevention.”