HIV acquisitions, safety, and pharmacokinetics of lenacapavir for HIV pre-exposure prophylaxis in pregnant and lactating women (PURPOSE 1): a substudy of a phase 3, randomised controlled trial.
Linda-Gail Bekker, Dhayendre Moodley, Dazon Dixon Diallo et al.
✦ AI-curated · Sources linked
In 30 seconds
This phase 3 randomized controlled trial evaluated the safety, pharmacokinetics, and HIV acquisition of lenacapavir as pre-exposure prophylaxis in pregnant and lactating women. Among 5345 enrolled women, 487 experienced pregnancies, resulting in 512 outcomes. Livebirth rates were 66% for lenacapavir compared to 54% and 57% for emtricitabine-tenofovir alafenamide and emtricitabine-tenofovir disoproxil fumarate, respectively.
Key findings
- 66% of pregnancies on lenacapavir resulted in livebirths compared to 54% on emtricitabine-tenofovir alafenamide.
- Pregnancy loss rates were similar across groups, with 31% on lenacapavir and 41% on emtricitabine-tenofovir alafenamide.
- Injection site reactions occurred in 33% of participants on lenacapavir, all grade 1 or 2.
- Lenacapavir was present in breastmilk with a median breastmilk-to-plasma ratio of 0.52.
Why it matters
The findings suggest that lenacapavir is a viable option for HIV pre-exposure prophylaxis in pregnant and lactating women, a population at increased risk for HIV acquisition. Understanding its safety and pharmacokinetics can inform clinical decisions and guidelines.