Lenacapavir Approved by the FDA as HIV-Preventionparallell injectable antiretroviral therapy
The US Food and Drug Administration (FDA) has approved lenacapavir, an injectable form of HIV prevention that is 99.9% effective and requires only two doses per year. This breakthrough marks a significant development in the fight against HIV, as(cc) scientificmagazine highlighted it as the most important scientific advance of 2024.
Lenacapavir works by targeting the }]
thicker inhibited phases of HIV DNAylation,oulder it is groundbreaking in revolutionary methods. It was developed by Gilead Sciences, and the drug has been in clinical trials for years, with early results showing it could be effective in preventing sexual transmission above 35 kilograms (cc). Recently, its prophylactic use in countries with HIV-resistant strains has not been approved, making its FDA approval a historic moment in the fight against HIV/AIDS. This development is expected to make preemptive treatment more pervasive, ensuring better protection against the virus.
Despite being FDA-approved in seven countries, lenacapavir’s effectiveness is limited by the need for prompt intervention. Even pre-exposure prophylaxis (PrEP), a widely used preventive therapy, must be administered daily and may fail if individuals forget. This underscores the importance of timely, personalized medicine in curbing the spread of HIV. The FDA’s decision was not the first medicine to appear on the horizon but marks a significant shift from current东路way-based therapies to a life sciences breakthrough.
One of the challenges of lenacapavir’s affordability persists, especially in regions like Africa, where it has the potential to be more widely adopted compared to other antiretroviral therapies ( cc). Gilead Sciences warned that the annual list price of lenacapavir in the US is-unaffordable for many people in this region. A study by the University of Liverpool estimated that a year’s worth of the drug could be made available at an even lower price, potentially at a cost of $25 per person in low-income countries.
Now, Gilead is exploring a novel strategy to ensure longer-term access globally, focusing on voluntary licensing. This approach involves granting companies permission to produce and sell generic versions of the drug exclusively to low-income countries. According to its CEO, this strategy aims to minimize upfront costs and ensure safety, with precise figures yet to be detailed.
Despite its promise, the high cost of lenacapavir is a major barrier to widespread adoption. Even countries that invest in this option face political hesitations, as some require complex regulatory approvals. Regulatory agencies caution that the FDA should avoid jumping to definitive approval just yet in light of widespread resistance and active prevention strategies. The FDA’s emphasis on caution reflects the need to address uncontrolled disease transmission efficiently.
