The Food and Drug Administration (FDA) granted approval on Wednesday for Gilead’s groundbreaking twice-yearly injection aimed at preventing HIV. This advancement has been hailed by the company and public health experts as a significant step toward alleviating the long-standing epidemic associated with the virus.
However, the rollout of the injectable treatment, named Yeztugo, may face hurdles, particularly from proposed cuts to federal funding for HIV prevention initiatives under the Trump administration’s directives.
In two pivotal clinical trials conducted last year, Gilead’s injection demonstrated extraordinary efficacy in virtually eradicating new HIV infections when administered biannually. This frequency makes it a more convenient alternative compared to existing prevention methods, which include daily pills from Gilead and a bi-monthly injection from GSK.
Yeztugo, positioned as a crucial resource in combatting an epidemic that resulted in approximately 1.3 million new infections and 630,000 deaths globally in 2023, according to the World Health Organization, could significantly reshape access to preventative care.
In the United States, Gilead CEO Daniel O’Day noted that the nation witnesses 700 new cases and 100 related deaths weekly, underscoring the urgent need for effective prevention strategies. The impact of HIV persists disproportionately among communities of color, as well as gay and bisexual men, other men who have sex with men, and transgender women.
“The significance of this for global public health is hard to overstate,” O’Day remarked, emphasizing that the injection “will truly change the trajectory of the epidemic as we roll it out globally.”
Jeremiah Johnson, executive director of PrEP4All, an organization advocating increased access to HIV prevention options, stressed that the injection’s ultimate effectiveness will hinge on accessibility.
Pricing, access, efficacy
Kknown generically as lenacapavir, Yeztugo carries an annual list price of $28,218 in the United States, prior to insurance, according to a Gilead spokesperson. This pricing aligns with existing branded prevention medications, also known as pre-exposure prophylaxis (PrEP).
For comparison, a month’s supply of Gilead’s daily PrEP pills, Truvada and Descovy, costs roughly $2,000 without insurance, totaling around $24,000 annually. In contrast, GSK’s Apretude, which requires monthly injections initially followed by bimonthly doses, is priced at about $4,000 before insurance.
Gilead has expressed its commitment to making Yeztugo accessible, anticipating broad insurance coverage similar to what exists for current prevention methods. The company detailed a copay savings program for eligible insured patients, potentially minimizing out-of-pocket expenses for Yeztugo to as low as zero. Additionally, a program exists for eligible uninsured individuals to access the injection at no charge.
Lenacapavir has already been approved for HIV treatment under the brand name Sunlenca, which is priced above $42,200 annually. A 2024 analysis indicated that the drug could be produced for as little as $26 to $40 per year.
Mizuho analysts project that lenacapavir’s peak sales could reach approximately $4 billion globally encompassing its roles in both HIV prevention and treatment.
O’Day stated the company is dedicated to ensuring availability of the drug for international use, as the virus “knows no boundaries.” Gilead recently granted licenses to six generic manufacturers to produce affordable versions of the injection in 120 low- to middle-income countries.
In an effort to bridge access gaps before lower-cost generics are available, Gilead pledged to provide doses for up to 2 million individuals at no profit.
Despite the availability of PrEP in daily pill form for the past decade, new HIV infections have either surged or stagnated in many regions. The adherence to daily medication can be challenging due to various factors such as convenience, stigma surrounding HIV, and PrEP, especially among communities beyond white men who have sex with men.
AIDSVu data reveals that Black Americans represent 39% of new HIV diagnoses but only constitute 14% of PrEP users, while Hispanic individuals account for 31% of new cases but only 18% of PrEP users.
“The stigma and cultural hurdles surrounding HIV prevention are still immense,” commented Johanna Mercier, Gilead’s chief commercial officer. “The option of a biannual injection provides the privacy that many individuals seek.”
Gilead intends to enhance awareness surrounding the injection’s convenience and its effectiveness, particularly among those currently disengaged from PrEP.
In one notable late-stage trial, 99.9% of patients who received Gilead’s injection did not contract HIV, translating to a 96% reduction in infection risk and showcasing an efficacy rate 89% higher than that of Gilead’s daily pill Truvada. The trial included a diverse array of participants, including cisgender men, transgender individuals, and gender nonbinary individuals who have sex with male partners.
Another trial involving cisgender women demonstrated that none of the participants who received Gilead’s injection contracted HIV, confirming 100% efficacy.
Proposed GOP funding cuts pose a threat
In the U.S., ensuring that underserved populations can access the injection necessitates comprehensive insurance coverage. Although most PrEP users are under commercial insurance plans, federal Medicaid remains vital for reaching lower-income communities.
According to the health policy research organization KFF, Medicaid serves as the primary insurance source for people living with HIV in the U.S., covering an estimated 40% of nonelderly adults with the virus. Thus, the potential cuts to Medicaid proposed by Republicans could jeopardize access to both HIV treatment and prevention.
Mercier believes Gilead’s current assessment indicates that Medicaid will continue to cover HIV services and support programs.
“Numerous effective programs in place, including Medicaid and other governmental initiatives, function as safety nets to ensure that individuals who seek access to HIV treatment and prevention can receive it,” she noted, while also highlighting Gilead’s resources for uninsured individuals.
Conversely, Johnson from PrEP4All cautioned that the “entire foundation for HIV prevention in America is currently under threat.”
He also pointed out that other proposed federal funding cuts could hinder the distribution of Gilead’s injection to healthcare providers and patients. For instance, the White House’s proposed budget for fiscal year 2026 features substantial reductions to various HIV prevention programs, particularly those administered by the CDC.
While certain funding streams persist, Johnson noted that they are doing so “in a manner that risks completely destabilizing the entire field of HIV prevention.”
He warned that if Congress does not respond to the proposed cuts, current PrEP users “could begin to drop off” and result in rising HIV infection rates in many communities.
