FDA approves breakthrough HIV prevention drug

The recent approval of lenacapavir, marketed as Yeztugo, by the FDA marks a pivotal advancement in HIV prevention strategies. This injectable drug is distinguished as the first and only pre-exposure prophylaxis (PrEP) option that requires administration only twice a year . Clinical trials, including the PURPOSE 1 and PURPOSE 2 studies, demonstrated remarkable efficacy rates—99.9% of participants remained HIV negative throughout the trial periods . Such findings suggest that lenacapavir could significantly reduce the incidence of sexually acquired HIV among adults and adolescents weighing at least 35 kg.

The US Food and Drug Administration on Wednesday approved Gilead Sciences' twice-yearly injection to prevent HIV – a move the company hailed as a major breakthrough in the fight against the sexually transmitted virus.

Drugs to prevent HIV transmission, known as pre-exposure prophylaxis or PrEP, have existed for more than a decade. But because they typically require taking a daily pill, they have yet to make a significant dent in global infections.

"This is a historic day in the decades-long fight against HIV," Gilead chairman and chief executive Daniel O'Day said in a statement.

Lenacapavir, marketed under the brand name Yeztugo, has been shown to reduce the risk of HIV transmission by more than 99.9 percent in adults and adolescents – making it functionally akin to a powerful vaccine.

A twice-a-year treatment could reach substantially more people, especially those who face stigma for taking a daily medication. For instance, researchers found that some single women in South Africa say taking a daily pill raises suspicion among their partners.

But the cost of the drug — roughly $28,000 a year — could price out many. While Gilead is taking steps to broaden access, the high price coupled with the U.S.'s steep cuts to foreign aid could prevent people in countries with the highest HIV burden from benefiting.

It has withheld funds that were due to states and territories for the effort, and the National Institutes of Health has terminated several grants related to research into preventive drugs.

Lenacapavir functions by inhibiting the virus's capsid protein, thereby obstructing its replication for approximately six months . The convenience of biannual injections presents an appealing alternative to daily oral PrEP medications. However, it is crucial to consider the financial implications of this breakthrough; with an annual cost estimated at $28,000, access to lenacapavir may be restricted for many individuals . Therefore, while this approval heralds a new era in HIV prevention efforts, addressing cost barriers will be essential for maximizing its impact on public health.

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Sara H

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