STUDY: HIV injectable drug offers pregnant, lactating mothers 100% protection

A Phase 3 clinical trial has found that the injectable HIV drug Lenacapavir provides 100% protection against infection for pregnant and breastfeeding women. The study confirms that the drug is safe for both mothers and infants, with no dose adjustments required.
Why it matters
This breakthrough addresses a critical gap in HIV prevention for a vulnerable population, potentially reducing mother-to-child transmission and maternal infection rates globally.
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SPECIAL REPORT | URN | A sub-study of the landmark clinical trial evaluating the safety and efficacy of the twice-yearly injectable HIV prevention drug, Lenacapavir, has found that it provides 100 percent protection against HIV infection among pregnant and breastfeeding women using it as pre-exposure prophylaxis (PrEP).
The Phase 3 PURPOSE 1 trial results, published in the Lancet Medical Journal last week and presented at the ongoing International AIDS Conference that opened on Sunday, show the injection to be safe for use in pregnancy.
While Lenacapavir was previously studied and demonstrated high efficacy and safety as PrEP in cisgender women, its use during pregnancy and lactation, when women are disproportionately vulnerable to HIV acquisition, was not described in the initial studies that formed the World Health Organisation’s global recommendation for the drug.
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