The Food and Drug Administration (FDA) has given the green light to Yeztugo, a new HIV-prevention medication developed by Gilead Sciences. The injectable drug, administered every six months, demonstrated near-complete prevention of HIV transmission in clinical trials.

News of Yeztugo’s approval has generated excitement among HIV prevention advocates, who believe the drug coudl considerably accelerate the decline of HIV transmission rates in the United States.

mitchell warren, executive director of the HIV advocacy nonprofit group AVAC, hailed the drug as “the single best chance in 44 years of HIV prevention.”

Experts suggest that Yeztugo (generic name lenacapavir), administered by healthcare professionals in clinical settings, offers a more effective alternative to existing oral HIV-prevention drugs. Its twice-yearly injection schedule addresses the challenges some individuals face in adhering to a daily pill regimen.

Currently, pre-exposure prophylaxis (PrEP) options like Truvada and Descovy, taken daily, reduce the risk of HIV infection by at least 99%.Though, inconsistent use significantly diminishes their effectiveness.

While PrEP has contributed to a considerable decline in HIV rates among white gay and bisexual men, HIV rates among Black and Latino gay and bisexual men have remained disproportionately high. One factor is that Black gay men are less likely to adhere to the daily pill regimen.

In late 2021, ViiV Healthcare’s Apretude, an injectable PrEP administered every two months, was approved. Despite demonstrating greater effectiveness than truvada in clinical trials, Apretude has seen limited adoption, with approximately 21,000 people currently using it, according to ViiV. The need for frequent clinic visits may have deterred some individuals.

“This is the single best opportunity in 44 years of HIV prevention.”

Yeztugo, with its twice-yearly injection schedule, offers an alternative for individuals who struggle with daily pill adherence, while also reducing the frequency of required clinic visits.

CDC estimates indicate that the annual HIV transmission rate decreased by only 17% in the decade following PrEP’s introduction, from 38,300 cases in 2012 to 31,800 cases in 2022. Though,a more meaningful decline of 12% occurred between 2018 and 2022.

The Trump administration launched the Ending the HIV Epidemic (EHE) initiative in 2019, allocating nearly $3 billion to combat HIV, including PrEP promotion, in 48 hotspot counties. These targeted jurisdictions experienced a faster 21% decline in estimated HIV transmissions from 2018 to 2022.

A CDC study published in October revealed a steady increase in PrEP use since 2014, with approximately 200,000 people receiving some form of PrEP in 2023.

Though, a separate CDC study published in May estimates that this represents only a small fraction of the 1.5 million gay and bisexual men who are considered good PrEP candidates.

The key question is whether lenacapavir can be effectively delivered to a significant number of individuals at risk of HIV who woudl not otherwise adhere to an oral PrEP regimen.

Dr. Susanne Doblecki-Lewis, chief of the division of infectious diseases at the University of Miami Miller School of Medicine, who is the site principal investigator for the lenacapavir clinical trial in gay men and a separate trial in people who inject drugs, believes lenacapavir has the potential to reduce HIV-related racial disparities, provided it is indeed readily available and affordable for uninsured or underinsured individuals.

However, she cautioned that barriers such as elaborate prior authorizations or high copays could hinder access and exacerbate existing disparities.

The Trump administration’s 2026 budget request proposes a $1.5 billion (35%) cut in domestic HIV funding, including the elimination of the CDC’s $794 million HIV-prevention division. While some aspects of the division might potentially be integrated into a new federal health department, $220 million in EHE funding would be maintained.

These budget cuts could significantly impact the ability of state and local health departments and nonprofit organizations to educate at-risk populations and doctors about lenacapavir and provide services to facilitate its use.

Another challenge for prescribers is ensuring that individuals at risk of HIV return for lenacapavir injections every six months. Studies have shown that fewer than half of oral PrEP users remain on the medication for six months or longer.

Historically, the National Institutes of Health (NIH) has funded research to support the implementation of new PrEP methods. However, budget cuts have negatively impacted HIV research, including PrEP, according to a compilation of canceled grants by a Harvard researcher.

While a federal judge recently ruled that some NIH grant terminations were unlawful, it remains uncertain whether the NIH will become more receptive to PrEP implementation grant proposals.

johanna Mercier, Gilead’s chief commercial officer, expressed optimism about achieving widespread insurance coverage for lenacapavir. Gilead will cover up to $7,200 annually in out-of-pocket costs for insured individuals receiving yeztugo, and its patient assistance program will provide the drug free to low-income uninsured individuals. A patchwork system is also available to assist the uninsured with covering clinic visits and lab tests.

Tristan Schukraft, CEO of Mistr, a PrEP-focused telehealth company, announced plans to promptly offer the drug through its storefronts in major urban gay neighborhoods and through partnerships with community-based clinics nationwide, including those serving uninsured individuals.

“We’re ready,” Schukraft said.