Background
Although oral pre-exposure prophylaxis (PrEP) is effective for HIV prevention, its routine use in cisgender women remains low. Effectiveness is contingent on high adherence and persistence post initiation, which many cite as a barrier for daily oral pills. In the Phase 3 PURPOSE 1 trial, twice-yearly subcutaneous (SC) lenacapavir (LEN) was safe and 100% efficacious in preventing HIV infection in cisgender women in South Africa and Uganda. We examined the PrEP administration preferences of PURPOSE 1 participants.
Methods
In PURPOSE 1 (NCT04994509), cisgender women aged 16-25 years were randomized 2:2:1 in a blinded fashion to receive SC LEN every 26 weeks, daily oral emtricitabine–tenofovir alafenamide (F/TAF), or daily oral emtricitabine–tenofovir disoproxil fumarate (F/TDF). Participants also received the alternate SC/oral placebo. During injection visits, participants completed an electronic questionnaire on their PrEP administration preference (twice-yearly injection or daily pills) and the potential impact of administration type on their feelings about HIV risk and PrEP adherence. These data were collected at baseline (prior to injection), Week (W) 26, and W52. Categorical responses were analyzed descriptively.
Results
Of 5368 randomized participants, 5218 completed the questionnaire at baseline. At the time of this interim analysis, 2561 participants had completed the W52 questionnaire. Approximately two-thirds of participants preferred twice-yearly injections over daily pills, few had no preference, and less than one-third preferred daily pills (Fig). Among those with a preference for either injection or pills, slightly more than half reported their preference as “strong”. More than half of participants reported they would feel more protected from HIV with twice-yearly PrEP injections vs daily pills (baseline: 59%; W26: 58%; W52: 61%). Most participants reported they would feel more confident about not missing a PrEP dose with twice-yearly injections vs daily pills (baseline: 60%; W26: 59%; W52: 61%).
Conclusions
Many participants reported a strong preference for twice-yearly injectable PrEP, whereas some indicated a preference for daily pills, highlighting the importance of choice. Importantly, many also felt that they were more likely to be protected from HIV, and remain adherent, on Q6M injections vs daily pills. Participant preference and clinical data strongly suggest twice-yearly LEN could increase the uptake of, adherence to, and persistence on PrEP among cisgender women.