Apretude PrEP Shows High Efficacy, Safety in Diverse Studies
New data at CROI 2025 shows zero cases of HIV acquisition reported with Apretude (cabotegravir long-acting (CAB LA) for PrEP in varied clinical settings and populations in 2 implementation studies in the US and Brazil.
At this week’s CROI conference, ViiV Healthcare presented real-world data on its long-acting injectable PrEP, cabotegravir long-acting (CAB LA), (Apretude). In it’s PILLAR study, there was zero HIV acquisition through 12 months and high persistence with CAB LA for PrEP. These new 12-month findings from the examined the effectiveness, diagnostic testing, persistence (time that an individual continued to receive injections), safety and tolerability of CAB LA in 201 participants. PILLAR is a phase 4 implementation trial assessing the integration of CAB LA for PrEP across 17 clinics in the US among a diverse population of men who have sex with men and transgender men, 26% of whom were Black and 38% Hispanic/Latino.
Persistence on CAB LA was high, at 85% (n=171/201) at six months and 72% (n=142/196) at 12 months; excluding five participants who completed the study post-data cutoff. Five participants missed an injection and received either oral CAB or alternative PrEP. Adverse events (AEs) related to CAB LA were uncommon, with injection site pain the most frequently reported (3%, n=6). Five percent of participants (n=11) had AEs leading to discontinuation, most commonly due to injection site pain.
“This study really has demonstrated that long-acting HIV prevention is acceptable, tolerable, again, highly effective,” said ViiV Healthcare Chief Medical Officer Harmony Garges, MD, MPH. There were no new acquisitions of HIV in the trial, and is showing that the persistence rate, meaning how long people remain on their PrEP with long acting, is very high.”
In the other trial, the ImPrEP CAB Brazil study (The Choice Cohort), assessed PrEP coverage and HIV incidence among 1,447 participants who were given the choice of CAB LA or oral PrEP (TDF/FTC) for HIV prevention. The Choice Cohort included PrEP-naïve, cisgender men who have sex with men, non-binary and trans people aged 18 to 30. As a comparison group, the study assessed 2,263 people of a similar demographic, initiating oral PrEP through the Brazilian public health system during the same period.
The results show that offering CAB LA injections significantly improved PrEP coverage and HIV prevention for young key populations, reinforcing the role of CAB LA in addressing adherence challenges some people face with oral PrEP.
Eighty-three percent of the 1,447 participants who were free to choose either CAB LA or oral PrEP chose CAB LA (1,200 participants) and there were zero HIV acquisitions reported over 798.4 person-years in The Choice Cohort. There were eight HIV acquisitions over 408.52 person-years reported in the comparison group (incidence rate 1.96 [95% CI 0.98-3.92] per 100 person-years).
“It demonstrated that if you gave people a choice of either oral prep or a long acting PrEP, you had more people accessing HIV prevention,” Garges said. “And that's really important in terms of ending the epidemic. And again, it also showed in that study that for those who chose the long acting therapy, there were no new cases of HIV, so high rates of effectiveness, and it was it was well tolerated.”
Apretude is PrEP that was FDA approved in 2021, and is used for preventing sexually transmitted HIV infection in adults and adolescents weighing at least 35kg who are at high risk of being infected. Individuals must have a negative HIV test prior to initiating the PrEP (with or without an oral lead-in with oral cabotegravir).
Garges discusses some of the feedback around taking daily PrEP including stigma and compliance. “Roughly 50% of people taking HIV medicines do have some sort of psychological burden with daily pills. So having a long acting injectable is a real benefit for them, because our medicine only needs to be dosed once every 2 months for treatment or prevention, and so you're taking someone who for treatment was having to take a medicine 365 days a year to now they only have 6 times a year.”
