Lenacapavir Data Supported HIV PrEP During Pregnancy
New findings indicate lenacapavir is a viable option for HIV prevention in pregnant and lactating individuals.
Updated on Sept. 18, 2026 in Pregnancy
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Data from the PURPOSE 1 trial, which concluded in September 2023, suggest that the twice-yearly injectable HIV prevention drug lenacapavir is suitable for pregnant and lactating individuals. The study monitored 509 pregnancies among 5,345 participants across trial sites including South Africa and Uganda.
Why it matters
Including pregnant and lactating individuals in HIV prevention research is critical to closing long-standing gaps in access to life-saving care. This evidence provides clarity on the safety profile of injectable PrEP options for those navigating reproductive health and motherhood.
In the Phase 3 PURPOSE 1 trial of 5,345 cisgender women and adolescents, researchers observed no new HIV infections among participants who received the injectable drug. Findings also showed a median breastmilk-to-plasma ratio of 0.52 and an infant plasma exposure ratio of 0.02.
The players
Lenacapavir
An injectable HIV medication administered every 6 months to prevent infection.
The details
Participants in the trial received a 600 mg oral loading dose followed by subcutaneous lenacapavir injections every 26 weeks. Researchers monitored drug levels every 13 weeks to ensure consistent efficacy throughout pregnancy and lactation. While 66% of pregnancies resulted in live births, the study continues to track maternal and infant outcomes following the drug's 2025 approval for pre-exposure prophylaxis.
Timeline
September 28, 2021: Enrollment began for the PURPOSE 1 trial.
September 15, 2023: Enrollment concluded for the study.
2025: Lenacapavir received approval for use as HIV PrEP.
Health Landscape
Historically, pregnant and lactating individuals were excluded from many drug trials, creating uncertainty regarding medication safety in these groups. The PURPOSE 1 trial reflects a growing standard of care that prioritizes inclusive research to ensure equitable access to HIV prevention.
If you are pregnant or lactating and considering HIV prevention, discuss the role of long-acting injectable options with your healthcare provider. Understanding the safety profile of preventative medications is a vital part of your prenatal and postnatal care plan.
The takeaway
Evidence supports lenacapavir as a viable HIV prevention tool for pregnant and lactating people. Always consult your obstetrician or primary care provider to evaluate the risks and benefits of any preventative therapy based on your individual health profile.
Further reading
For more information on managing health during this life stage, visit our section on Pregnancy.
Source note: This article includes information reported by Healio.
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