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Mamlaka ya Chakula na Dawa ya Marekani (FDA) imeidhinisha dawa mpya iitwayo Lenacapavir ya kuzuia maambukizi ya Virusi vya UKIMWI, ambayo imeelezwa kupunguza hatari ya maambukizi kwa asilimia 99.9.
Dawa hiyo inayotolewa kwa sindano mara mbili kwa mwaka, itazinduliwa karibuni nchini humo na kusambazwa katika mataifa mengine.
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Lenacapavir becomes the first and only twice-yearly option for HIV prevention.
The FDA has approved lenacapavir (Yeztugo; Gilead Sciences), a twice-yearly injectable HIV-1 capsid inhibitor, for the prevention of HIV as preexposure prophylaxis (PrEP), according to reports from NBC News, USA Today, and CNBC and a news release from Gilead Sciences.1-4
“This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic,” Daniel O’Day, chairman and CEO of Gilead Sciences, said in a news release. “This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention."4
Data from pivotal phase 3 trials provided the backing for this approval. In PURPOSE 1 (NCT04994509), lenacapavir was found to be highly effective among trial participants, with 0 HIV infections observed in the lenacapavir group (0/100 person-years; 95% CI, 0.00–0.19) compared with background HIV incidence, which translated to a 100% reduction in HIV infections.5,6
Investigators of PURPOSE 2 (NCT04925752) found that lenacapavir was highly effective at reducing HIV infections among trial enrollees, with 99.9% of participants treated with lenacapavir not acquiring HIV infection in the trial, despite the high reported levels of sexual behavior and sexually transmitted infections observed among trial participants.7,8
In both PURPOSE 1 and 2, patients were highly adherent to lenacapavir injections. At week 26, 91.5% and 91.0% of participants from the respective trials received on-time injections, and at 1 year, these rates were each 92.8%. With lenacapavir only necessitating injections twice-yearly, it now serves as one of the most convenient and effective HIV treatment options available to patients.5,7
Based on these positive trial results, the FDA accepted lenacapavir new drug applications for priority review in early 2025, which followed a breakthrough therapy designation granted by the FDA in October 2024. These processes allowed for lenacapavir to have an expedited review process due to the substantial improvements it could make compared with currently available therapies.9
Lenacapavir was originally developed as a therapy for adults living with HIV who harbored infections resistant or intolerant to available treatments or for whom safety considerations prevented using other PrEP options. In 2022, it received approval from the FDA for patients with HIV-1 infection in heavily treatment-experienced (HTE) adults with multi-drug resistant (MDR) infection.10,11
Source:
FDA Approves Twice-Yearly Lenacapavir for HIV Preexposure Prophylaxis