No women taking long-acting cabotegravir (Apretude) for HIV pre-exposure prophylaxis (PrEP) developed an HIV infection, even when some experienced short delays before maintenance injections, according to a U.S. study of routine clinical care.
The study tracked 315 cisgender and transgender women who started cabotegravir between December 2021 and December 2024 as part of the OPERA longitudinal cohort. Over a median follow-up of 13 months, there were no cases of incident HIV. Armas-Kolostroubis, a researcher on the study, stated that the results demonstrate the high, real-world effectiveness
of the drug for women in the U.S. despite ongoing sexual transmission risk.
Patient Demographics and Adherence
The median age of the participants was 28 years. Among the group, 43% were Black, 32% were transgender, and 43% had a BMI of at least 30 kg/m2. Researchers noted that cabotegravir reached a different population than oral PrEP options; for example, 38% of women on the long-acting injectable received Medicaid, compared to 8% of those using oral PrEP. Additionally, 32% of cabotegravir users were transgender, while 19% of oral PrEP users were.
Most participants adhered to the regimen, which consists of two monthly injections for the first two months followed by injections every two months. Specifically, 80% of the 315 women received the full initiation sequence. However, 38% of women who received at least one maintenance injection eventually discontinued the therapy. Of those who stopped, 25% resumed injections after a median gap of 31 weeks.
Clinical Implications
Armas-Kolostroubis attributed delays in clinical treatment to factors such as work and family reasons. She noted that the pattern of interrupting and resuming the drug may reflect changes in a patient’s perception of risk or actual risk over time.
Because of the drug’s effectiveness, Armas-Kolostroubis urged that providers should not discard the possibility of continuing PrEP
following delays, but instead emphasize that it remains a very effective method. Approved in 2021, long-acting injectable cabotegravir is indicated for adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition.
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