Lenacapavir Data Supported Pregnancy Use
New study results showed the drug is effective as HIV prevention for pregnant and lactating women.
Updated on Sept. 18, 2026 in Pregnancy
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Data from the phase 3 PURPOSE 1 trial, which concluded in September 2023, found that the injectable drug lenacapavir is an effective option for HIV pre-exposure prophylaxis among pregnant and lactating women. No new HIV infections occurred during the study among participants receiving the medication.
Why it matters
Including pregnant and lactating women in clinical research is essential to ensure that life-saving prevention tools are safe and accessible for these populations. The inclusion of these groups was directly supported by advocacy from community members.
The study enrolled 5,345 participants and recorded 509 pregnancies. Lenacapavir showed a median breastmilk-to-plasma ratio of 0.52, while infant plasma exposure remained low at 0.02.
The players
PURPOSE 1
This is a phase 3 clinical trial conducted in regions including South Africa and Uganda to test the efficacy of lenacapavir for HIV prevention.
The details
Participants in the trial received a 600 mg oral loading dose of lenacapavir followed by subcutaneous injections every 26 weeks. Researchers monitored drug levels every 13 weeks throughout pregnancy and the lactation period to track safety and efficacy.
Timeline
September 28, 2021: Enrollment began for the PURPOSE 1 trial.
September 15, 2023: Enrollment concluded for the PURPOSE 1 trial.
2025: Lenacapavir was officially approved for HIV PrEP use.
Culture Shift
This research reflects a growing shift toward inclusive trial designs that move beyond historical exclusions of pregnant women from pharmaceutical testing. By validating medication safety for this demographic, the study sets a new standard for maternal health in global HIV prevention efforts.
For pregnant or lactating individuals, these findings provide critical information regarding the safety of using lenacapavir as a consistent HIV prevention strategy. The twice-yearly injection schedule offers a practical alternative to daily oral medications, potentially improving adherence and health outcomes.
The takeaway
The successful integration of pregnant participants into this trial demonstrates that inclusive research is both possible and necessary for public health equity. Patients should consult their healthcare providers to discuss how these findings influence current options for HIV prevention.
What happens next
Researchers intend to continue long-term surveillance of pregnancy outcomes following the widespread rollout of lenacapavir for HIV prevention.
Further reading
Learn more about the latest clinical developments in Pregnancy.
Source note: This article includes information reported by Healio.
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