No HIV Infections Seen With Cabotegravir PrEP in Real-World Study

No women receiving long-acting cabotegravir (Apretude) for HIV preexposure prophylaxis (PrEP) acquired HIV during a real-world study of routine clinical care, despite short delays before some maintenance injections.¹ The findings, presented at the 26th International AIDS Conference (AIDS 2026) by Laura Armas-Kolostroubis, MD, of the AIDS Healthcare Foundation in Dallas, Texas, come from an analysis of 315 women who started cabotegravir PrEP from December 2021 through December 2024 as part of the OPERA longitudinal cohort.

Over a median follow-up of 13 months, no incident HIV infections occurred despite less-than-perfect adherence to the cabotegravir regimen.¹ Overall, 88% of 1193 maintenance injections were delivered on time, with late injections occurring a median of 8 days late, and 44% of women had at least 1 delayed maintenance injection.

OPERA cohort data show high real-world effectiveness despite frequent short delays in maintenance injections

Among the 315 women, 80% completed the cabotegravir initiation sequence of 2 monthly injections and were followed for a median of 13 months afterward. Of the 252 women who completed initiation, 83% received at least 1 maintenance injection, with a median of 4 maintenance injections per person. More than half of women, 56%, received all subsequent maintenance injections on time, and those who did not had a median of only 1 late injection.² Among women with a late injection, 89% had a delay of less than 31 days that did not require restarting the cabotegravir initiation sequence.

Overall, 38% of women who received at least 1 maintenance injection discontinued cabotegravir PrEP, and 25% of those who discontinued resumed injections a median of 31 weeks after their last dose, consistent with other real-world evidence supporting high effectiveness of cabotegravir for PrEP.

Cabotegravir Reached a Different Population Than Oral PrEP

Among 5330 women who started any PrEP option during the study period, 6% initiated cabotegravir, 80% started daily oral tenofovir disoproxil fumarate/emtricitabine (Truvada), and 14% started daily oral tenofovir alafenamide/emtricitabine (Descovy). Women initiating cabotegravir had a median age of 28 years; 43% were Black, 32% were transgender, and 43% had a body mass index of at least 30 kg/m².¹

A greater proportion of women who chose cabotegravir were transgender compared with those who chose oral PrEP, 32% versus 19%, and a greater proportion were covered by Medicaid, 38% versus 8%, part of a broader push to close equity gaps in HIV prevention access. The OPERA cohort tracks more than 172,000 people with HIV, 911,000 people without HIV, and 86,000 who have received PrEP.

The results seem to demonstrate the high real-world effectiveness of cabotegravir PrEP in cisgender and transgender women in the US, and that despite the delays observed, clinicians should reassure patients the method remains highly effective rather than discontinuing it. Delays were attributed to factors including family responsibilities, work schedules, and other life circumstances.

Long-acting lenacapavir (Yeztugo), a twice-yearly injectable PrEP option, had not yet been approved during the study period.¹ Lenacapavir is positioned to further boost PrEP uptake and persistence given its less frequent dosing schedule.

Reference
Armas-Kolostroubis L, et al. No HIV acquisitions among women on cabotegravir long-acting injectable PrEP despite mostly short injection delays in the US OPERA Cohort. Presented at: International AIDS Conference (AIDS 2026); 2026. Abstract 3615.