FDA​ OKs Twice-Yearly HIV Prevention Shot: Gilead’s Yeztugo

⁣ ⁤ Updated June 18, 2025

The​ Food and Drug Administration on Wednesday approved​ Gilead‌ Sciences’ Yeztugo,⁢ a⁤ twice-yearly ⁤antiviral injection designed to ‍prevent HIV. ⁤Company leaders and some‌ experts suggest this new pre-exposure prophylaxis‌ (PrEP) option could considerably‍ advance efforts to end the decades-long HIV ​epidemic.

Yeztugo’s efficacy was demonstrated in clinical trials last year, showing near-complete prevention of new HIV infections with twice-yearly doses. This less frequent dosing schedule offers a‍ more convenient choice⁢ to existing HIV ​prevention medications, including daily pills from⁤ Gilead ⁢and another injection from ‌GSK, administered every other month.

According to the World‌ Health Organization, the HIV epidemic‌ resulted in 1.3 million ‌new infections and ‍630,000 deaths globally in 2023. Gilead CEO Daniel O’Day noted that the U.S.sees 700​ new⁣ cases and 100 HIV-related deaths each week.HIV disproportionately affects people of color, gay‍ and⁢ bisexual men, other men‍ who have sex with men, ⁣and transgender women.

O’Day called the approval a major milestone for ‌global​ public⁢ health, saying⁣ the injection “really ‍will bend the arc of the epidemic as we roll this out across the globe.”

Jeremiah Johnson, executive director of PrEP4All, emphasized that the​ drug’s impact hinges on accessibility.

Pricing, access, efficacy

The annual list ‌price ⁤for Yeztugo​ (lenacapavir) is $28,218 in the U.S. before ​insurance, according to Gilead. This aligns with current branded ‍PrEP⁣ medications. ​A ⁣month’s supply of⁤ Gilead’s ⁣daily PrEP pills, Truvada and Descovy, costs about $2,000 without insurance, totaling​ $24,000 ⁤annually. GSK’s Apretude costs ⁣roughly $4,000 per dose before⁤ insurance, with an initial monthly regimen for two months, followed by every-other-month injections.

Gilead⁢ said it anticipates broad⁤ insurance coverage ‌for Yeztugo and offers a copay savings⁤ program for eligible insured patients, perhaps reducing out-of-pocket expenses to zero. Uninsured individuals can also ​access the injection for free through a Gilead program.

Lenacapavir, already approved for HIV treatment under the brand name Sunlenca, is priced at more then‍ $42,200 per year. An analysis last year estimated the drug could be⁤ manufactured for $26 to $40 annually.

Mizuho analysts project peak global sales⁢ of $4⁣ billion for lenacapavir, encompassing ⁤both HIV prevention and treatment.

O’Day said Gilead‍ is committed to global supply, noting the virus “knows‌ no boundaries.” In October, Gilead licensed six generic manufacturers to produce and sell lower-cost versions in⁢ 120 low- ⁢and lower-middle-income‍ countries. The company also pledged to supply doses for up⁤ to 2 million people at no ⁣profit until generic versions⁣ are available.

Despite a decade of ⁣PrEP availability via ‍daily pills, infection⁢ rates have remained stagnant or increased in many areas. Consistent pill adherence can be challenging due⁤ to inconvenience and⁤ stigma, particularly outside⁢ white men who have sex with men.

AIDSVu,a public resource ​for HIV surveillance data from Gilead and Emory University,reports⁢ that⁣ Black ‍Americans account for 39% of new HIV⁢ diagnoses but only 14% of PrEP users. Hispanic people represent 31% of new diagnoses but ​only 18% of⁣ PrEP users.

Gilead’s chief⁣ commercial officer, Johanna Mercier, said the twice-yearly injection offers​ a level of privacy that ⁢many ⁣seek. The company aims to⁣ raise awareness of this convenience ⁣and the‌ injection’s efficacy, especially among those not currently using PrEP.

Clinical trials showed high efficacy rates.One trial found a 99.9% prevention rate among ​patients ​receiving Gilead’s injection, with ⁤only ‌two⁣ infections among over 2,000⁤ participants. This represents a 96% reduction in HIV risk and 89% greater effectiveness than‌ Gilead’s⁢ daily⁣ pill, Truvada. another trial involving over‌ 5,000⁣ cisgender​ women showed 100% efficacy, with no​ infections among⁣ roughly ‍2,000 participants ​receiving the injection.

Proposed federal funding cuts pose a threat

Broad insurance⁢ coverage⁤ is crucial for ensuring access to underserved populations in the U.S. The HIV+Hepatitis⁤ Policy Institute reports‌ that most PrEP users have ‍commercial insurance, ​but Medicaid is vital for​ reaching lower-income ⁤communities. KFF, a health policy research organization, ‌estimates⁤ that Medicaid‍ covers 40%‍ of nonelderly adults with HIV in the U.S.

Proposed Republican funding cuts to Medicaid pose a significant threat to HIV⁢ treatment⁢ and prevention access. Mercier said Gilead believes Medicaid will continue to cover HIV services and support, citing existing⁤ safety nets and Gilead’s programs for uninsured individuals.

Johnson, however, contends that “the entire foundation for HIV prevention in ‍America is under attack at this moment.”‌ He added ⁣that proposed federal funding cuts, including those in the white House’s budget for fiscal year ⁢2026, ⁢could destabilize HIV prevention ‌efforts.

Johnson ⁢said that if Congress does not push back on the White House’s proposed cuts, ​people currently taking PrEP may lose access.

What’s next

Gilead plans to focus on ensuring broad access to Yeztugo, particularly for ‌underserved populations, ⁢while ⁤navigating potential challenges related‍ to ‍federal funding and insurance coverage. the company aims ‌to work with healthcare‍ providers and community organizations to raise awareness ⁤and promote ‌the⁢ benefits of this new HIV prevention ⁤option.