Studies continue to show benefits of long-acting injections for HIV prevention
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SEATTLE — Two studies presented at the Conference on Retroviruses and Opportunistic infections demonstrated high adherence levels and acceptability of long-acting, injectable PrEP for HIV prevention among varying groups of people.
One of the two studies found that 89% of Black cisgender men and transgender women who have sex with men adhered to a regimen of cabotegravir injections given every 8 weeks — a regimen that has been approved by the FDA for HIV prevention since 2021.
The other study, a much smaller one conducted among cisgender female adolescents in three southern African nations, found that 100% of participants adhered to the regimen and none acquired HIV.
“This really highlights that this works extremely well in the populations that we are prioritizing for HIV prevention in the United States,” Hyman Scott, MD, MPH, clinical research medical director at Bridge HIV in the San Francisco health department, said during a press conference.
“[The] next steps to implementation really have to ensure access that’s easy, that is targeted to supporting those individuals who might benefit the most from it, and that is really going to be a future focus of our work for HIV prevention.”
Scott and colleagues presented results of a subanalysis on data from the HIV Prevention Network 083 study (HPTN 083), phase 2b/3 randomized multicenter double-blind, double-dummy clinical trial that enrolled more than 4,500 Black cisgender men and transgender women who have sex with men in Africa, Asia, Latin America and the United States. The trial showed the injection regimen offered superior protection against HIV infection compared with daily oral PrEP.
For the new analysis, Scott and colleagues analyzed data comparing regimen adherence among Black men and transgender women study participants and non-Black men and transgender women in the U.S. They found that participants in both groups were more likely to adhere to the injection regimen than daily oral regimen. Specifically, adherence to on-time cabotegravir injections was 89.7% and similar among the two groups, whereas adherence to daily oral PrEP was 64.7% and 81.2% among Black and non-Black transgender women and men who have sex with men, respectively.
The researchers also found that HIV incidence was 72% lower in the cabotegravir arm compared with the daily oral PrEP arm, 0.58% vs. 2.11% (HR = .28 (95% CI, 0.096-0.83), which was in line with the broader results from HPTN 083.
Additionally, Sybil Hosek, PhD, a clinical psychologist and HIV researcher at Cook County Health in Chicago, presented results from the phase 1 HPTN 084-01 study, called the LIFT, which recruited 55 adolescent people assigned female at birth aged younger than 18 years in South Africa, Uganda and Zimbabwe in 2021 during the COVID-19 pandemic.
Noting there was “high interest in the study,” Hosek said the open-label, single-arm study with no control group was focused on safety in the age group.
Participants were given 1 month of oral cabotegravir lead-in before a 6-month regimen of injections — five shots — followed by an open-label follow-up period, when they were given the option of continuing with the injection regimen or switching daily oral PrEP.
According to Hosek, the “product was acceptable to the adolescents and adherence was exceptional — 100% of injections that were expected to occur did occur.”
She added that there were no safety signals, no serious adverse events, no HIV infections and no discontinuation of participation because of intolerability, such as pain at injection sites, with 92% of participants opting to continue the injection regimen.
“These studies are critically important when we have a new product because our goal is simultaneous licensure of new products for adolescents and adults so that there is no access issues for those in the younger age range,” Hosek said.
Both Scott and Hosek noted that avoiding access issues for any PrEP medication is significant, highlighting that specific populations are being prioritized, in and out of the U.S., with Scott saying it is likely that access will be an issue.
“We learned this with oral [PrEP] and all of the efforts to provide access for individuals,” Scott said. “There are often barriers, even if someone has coverage, including whether or not it’s covered as a medical benefit or a pharmacy benefit that can change access even if there is, quote, coverage that someone has. So, 100%, this is going to be a problem getting injectable cabotegravir to people who we want to have access to it.”
References:
- Hosek S, et al. Abstract 162. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 19-22, 2023; Seattle.
- Scott H, et al. Abstract 161. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 19-22, 2023; Seattle.
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