FDA Approves New Long-Lasting HIV Prevention Drug

Gilead Sciences has recently achieved a significant milestone in HIV prevention, with the Food and Drug Administration (FDA) approving its twice-a-year injection designed to prevent HIV infections. This groundbreaking medication, known scientifically as lenacapavir and marketed as Yeztugo, was lauded by company executives as a “very real opportunity” to bring an end to the ongoing HIV epidemic. Clinical trials for Yeztugo demonstrated exceptional efficacy, with nearly all study participants who received the twice-yearly injection remaining HIV negative, showcasing near-total protection against the virus.
The approval of Yeztugo on June 18 follows successful trials that confirmed its high effectiveness. This new treatment option offers a significant advancement compared to existing HIV prevention drugs, which primarily consist of daily oral pill regimens or an injection every two months (cabotegravir, sold as Apretude). While daily pills are more affordable at approximately $1 per pill, they do not work for everyone and have not had a substantial global impact on the disease. Apretude, the other long-lasting HIV prevention drug, requires an injection every two months and costs around $24,000 annually, with about 21,000 Americans currently using it. In contrast, roughly 500,000 Americans rely on daily oral medications for HIV prevention.
Advocates are optimistic about Yeztugo's potential to revolutionize prevention efforts. Mitchell Warren, executive director of AVAC, an anti-HIV organization, stated, "We're on the precipice of now being able to deliver the greatest prevention option we've had in 44 years of this epidemic." However, concerns have been raised regarding potential barriers to global distribution and access. Proposed funding reductions for crucial programs such as Medicaid and the President's Emergency Program for AIDS Relief (PEPFAR) could severely limit access to this new drug for many, despite Gilead's assertion that health insurance and patient-assistance programs would cover costs for most users. Lenacapavir is also currently prescribed to treat individuals with HIV infections that are resistant to other medications, at an annual cost of $42,000 per patient, though most do not pay the full price.
The introduction of Yeztugo comes at a critical time, with over 39,000 people in the United States contracting HIV in 2023. The estimated lifetime treatment cost for an HIV patient is approximately $1.1 million, underscoring the immense value of effective prevention strategies. This new twice-a-year injection represents a powerful tool in the fight against HIV, offering a convenient and highly protective option that could significantly reduce new infections and move the world closer to eradicating the disease, provided equitable access can be ensured.
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