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Cape Town, 19 July 2025 — Groundbreaking new data presented at the 13th International AIDS Society Conference on HIV Science signals a major advance in HIV prevention for women of reproductive age. Two long-acting injectable pre-exposure prophylaxis (PrEP) drugs—lenacapavir and cabotegravir—have demonstrated safety, strong efficacy, and minimal risk for infants when used during pregnancy and breastfeeding.
Key Findings on Lenacapavir
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Effective and Well-Tolerated: Results from the large PURPOSE 1 trial showed that lenacapavir maintained protective blood levels throughout pregnancy, eliminating the need for dose adjustments. Tolerability and efficacy in pregnant women matched results seen in non-pregnant populations.
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Minimal Infant Exposure: Pharmacokinetic studies revealed lenacapavir was present in breast milk at just over half the concentration found in maternal blood, and only about 2% of that reached the infants’ bloodstream.
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Pregnancy Outcomes: Among over 2,100 women receiving lenacapavir, pregnancy rates, birth outcomes, and incidence of complications—such as hypertension and foetal distress—were comparable with those receiving other PrEP regimens or the general population. Six birth defects were recorded, aligning with standard background rates.
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No HIV Acquisitions: Notably, no participants using lenacapavir acquired HIV during the study.
Reassuring Data on Cabotegravir
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Sustained Protection During Breastfeeding: The Botswana-based Tshireletso study found that cabotegravir, administered every eight weeks starting just after childbirth, yielded maternal drug levels well above the protective threshold. Cabotegravir in breast milk averaged only 1.4% of the maternal blood level, resulting in minimal infant exposure (median 5% of the maternal dose).
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No Safety Signals: Infants exposed via breastfeeding showed no drug-related adverse effects, and no new HIV infections were recorded among women on cabotegravir.
HPTN 084: Long-Term Outcomes for Pregnant Women
An open-label extension of the HPTN 084 study further reinforced cabotegravir’s safety profile during pregnancy. Among 433 pregnancies, those in the cabotegravir group experienced similar outcomes to those on alternative PrEP or non-intervention groups. Most pregnancies resulted in term births with healthy birth weights, and no maternal deaths or HIV infections were reported. Occurrences of gestational hypertension were higher in the cabotegravir group, but serious complications were rare, and the rate of congenital anomalies remained low.
Policy Impact and Recommendations
Following these robust studies, both the World Health Organization (WHO) and the US Food and Drug Administration (FDA) have updated guidance to support the use of lenacapavir and cabotegravir PrEP for women during pregnancy and breastfeeding who are at risk of HIV. The new WHO guidelines now state that PrEP should not be discontinued during pregnancy or lactation. Decisions about PrEP use should be individualized after consulting with a healthcare provider and considering up-to-date safety and efficacy data.
“Women of reproductive age should not face barriers to accessing these life-saving PrEP options. Ongoing research and post-marketing safety surveillance remain essential,” said Professor Linda-Gail Bekker, principal investigator of the PURPOSE 1 study.
Why This Matters
Women in pregnancy and postpartum remain disproportionately vulnerable to HIV infection. Until recently, they have often been excluded from PrEP studies, leading to gaps in evidence and options. These new results provide critical reassurance on both efficacy and safety, paving the way for wider access and protection for mothers and their infants.
Disclaimer: This article summarizes recent research and medical guidelines. Individual decisions about HIV prevention, especially during pregnancy and breastfeeding, should always be made in consultation with a qualified healthcare provider. Ongoing studies and surveillance may continue to refine these recommendations.
