HIV Prevention Investigational Therapy Superior Vs Standard of Care

ViiV Healthcare announced today its long-acting injectable cabotegravir administered every two months is 89% more effective than daily pills in preventing HIV acquisition in women.

The findings come from the HPTN 084 study, which was designed to evaluate the safety and efficacy of investigational, long-acting, injectable cabotegravir for HIV prevention in women. Following a pre-specified interim analysis, the DSMB indicated that cabotegravir met the primary objective of demonstrating superiority when compared to the current standard of care for women, daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg (FTC/TDF) tablets. The study showed cabotegravir was 89% more effective than daily oral FTC/TDF for pre-exposure prophylaxis (PrEP).

“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 ground-breaking results confirming the superior efficacy of long-acting cabotegravir for PrEP,” Kimberly Smith, MD, MPH, Head of Research & Development at ViiV Healthcare said. “Women need more effective choices for HIV prevention.”

The study involved 3223 participants in 20 sites across seven countries in sub-Saharan Africa (Botswana, Kenya, Malawi, South Africa, eSwatini, Uganda and Zimbabwe). HPTN 084 is the first study of long-acting injectable therapy for HIV prevention among women.

The data showed that there was a statistically significant advantage for the women who received cabotegravir compared with the women who received FTC/TDF. While both were highly effective at preventing HIV in the study population, cabotegravir was superior.

One investigator involved in the trial discussed the issue of HIV prevalence in women in certain areas and it was relevant the study took place in this area of the world.

“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,” Sinead Delany-Moretlwe, MBBCh, PhD, DTM&H, HPTN 084 protocol chair and research director at Wits RHI, University of the Witwatersrand in Johannesburg, South Africa, said. “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. 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.”

Cabotegravir is also being studied as a combination with the injectable rilpivirine (RPV). When administered every 2 months to treatment-experienced patients with HIV-1 infection, these therapies demonstrated durable virologic suppression and high levels of patient satisfaction over the first 12 months of the phase 2b POLAR study.

Results from the multicenter, open-label, LATTE rollover study were reported at the virtual ID Week 2020.

Eligible participants included virologically suppressed, HIV-positive adult LATTE participants who had completed ≥312 weeks of study, received once-daily oral CAB 30 mg + RPV 25 mg treatment, and had plasma HIV-1 RNA < 50 c/mL at screening. These participants, 97 in total, were offered a choice between switching to CAB LA+RPV LA every 2 months (Q2M) or switching to the oral fixed-dose combination of dolutegravir (DTG)/RPV once daily.