Nine countries have launched lenacapavir for HIV prevention, with roughly 66,000 people newly started on it. In at least two countries, demand has already outrun the available doses.
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The modelling study puts 719,384 people on PEPFAR-funded oral PrEP in 28 African countries at the end of 2024. Most projected infections fall on key populations whose coverage was already under 6%.
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THE DRUG DOCKETThe recommendation covers people weighing at least 35 kg and rests on two trials in which lenacapavir cut HIV infections by 100% and 96% against background incidence.
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The guidelines pair the new injectable with a second, quieter recommendation: use simplified rapid diagnostic testing to start and continue long-acting PrEP, rather than more complex assays.
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THE DRUG DOCKETLenacapavir is the first HIV pre-exposure prophylaxis given every six months. Two phase 3 trials found zero and two infections in the lenacapavir groups against background rates above 2 per 100 person-years.
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