Conference Coverage

No HIV Acquisitions With Long-Acting Cabotegravir PrEP Among Women in US Cohort

Anthony Calabro, MA

Key Highlights

  • No HIV acquisitions were observed among women receiving long-acting injectable cabotegravir for pre-exposure prophylaxis (PrEP).
  • Among women with at least 1 maintenance injection, 44% had at least 1 late maintenance dose, and most delays were short.
  • Overall, 80% of women completed the 2-injection initiation regimen; 87% of these women received the second injection on time.
  • Some women who did not complete initiation or who discontinued cabotegravir subsequently resumed injections.

No HIV acquisitions occurred among cisgender and transgender women receiving long-acting injectable cabotegravir for pre-exposure prophylaxis (PrEP) in the US-based, real-world OPERA Cohort, according to results presented at the 26th International AIDS Conference (AIDS 2026).

Although the efficacy of long-acting cabotegravir PrEP has been demonstrated among cisgender and transgender women, the researchers noted that information about its effectiveness in real-world practice remains limited.

The analysis included 315 adult cisgender or transgender women without HIV who received at least 1 long-acting cabotegravir PrEP injection between December 21, 2021, and December 31, 2024. Participants were followed until April 30, 2025, loss to follow-up, or death.

The researchers assessed adherence to maintenance injections and HIV acquisition until treatment discontinuation or the first censoring event. Reinitiation, defined as receipt of at least 1 additional injection after incomplete initiation or discontinuation, was assessed until the first censoring event.

Study Findings

Among the 315 women who initiated long-acting cabotegravir PrEP, 66% had previously received an oral PrEP prescription. At the first injection, the median age was 28 years, 43% of participants were Black, 32% were transgender, 43% had a BMI of at least 30 kg/m², and 32% had received a sexually transmitted infection diagnosis during the preceding 12 months. Within 2 weeks of the first injection, 84% had received an HIV test.

A total of 252 women (80%) completed initiation by receiving the second injection within 67 days. Among these women, 220 (87%) received the second injection on time, defined as 23 to 37 days after the first injection, whereas 32 (13%) received it late.

Of the 63 women who did not complete initiation, 23 (36%) subsequently received at least 1 additional injection, with a median interval of 105 days.

During a median follow-up of 13 months, 92 of the 210 women with at least 1 maintenance injection (44%) had at least 1 late maintenance injection. Among women with a late injection, 64% had only 1 late injection. The subsequent injection was administered a median of 8 days after its target date.

Among the 92 women with at least 1 late maintenance injection, 82 (89%) had at least 1 short delay that did not require reinitiation, and 14 (15%) had at least 1 long delay requiring reinitiation. These categories were not mutually exclusive.

Eighty women discontinued long-acting cabotegravir PrEP. Of these, 20 (25%) subsequently received at least 1 additional injection, with a median interval of 216 days. No HIV acquisitions were observed among women receiving long-acting cabotegravir PrEP.

Clinical Implications

According to the researchers, the findings indicate that long-acting cabotegravir PrEP was highly effective against HIV acquisition among women receiving routine clinical care in the United States, despite mostly short injection delays. Reinitiation among women who did not complete initiation or who discontinued treatment indicated continued interest in this PrEP option.

The authors noted that incomplete documentation of oral bridging therapy may have contributed to overestimation of injection delays and discontinuations.

Expert Commentary

“Long-acting cabotegravir for PrEP was highly effective against HIV acquisition among women in routine clinical care in the US,” the researchers concluded.

Reference
Armas-Kolostroubis L, Brunet L, Toeque MG, et al. No HIV acquisitions among women on cabotegravir long-acting injectable PrEP despite mostly short injection delays in the US OPERA Cohort. Abstract OAC2805. Presented at: 26th International AIDS Conference (AIDS 2026); July 30, 2026.