The recent approval of Yeztugo, a twice-a-year injection to prevent HIV, has the potential to significantly reduce the spread of the virus in the United States and globally. However, health care experts express concerns regarding the cost and accessibility of this groundbreaking treatment. Developed by Gilead Sciences, Yeztugo (generic name lenacapavir) received the green light from the Food and Drug Administration (FDA) on Wednesday.
Yeztugo comes with a hefty price tag of $14,109 per injection, totaling $28,218 annually before insurance coverage. “Anyone who is likely to be exposed to HIV through sexual contact, who is interested in subcutaneously injected medications, and who does not have HIV” can benefit from Yeztugo, according to Raphael J. Landovitz, director of the UCLA Center for Clinical AIDS Research and Education. This medication is particularly aimed at individuals at high risk who may struggle to adhere to daily preventive pills like Descovy or Truvada.
Yeztugo is categorized as a pre-exposure prophylaxis (PrEP) designed to prevent new sexually transmitted HIV infections in adults and adolescents weighing at least 35 kg (77 pounds). Administered biannually in clinics, the FDA's approval was based on data from two pivotal clinical trials. In one randomized trial involving over 5,000 young women and girls in South Africa and Uganda, none contracted HIV after receiving Yeztugo. Another trial showed only two HIV infections among men and gender-diverse participants who received Yeztugo, compared to nine infections in those taking Truvada.
According to Gilead, only HIV-negative individuals should receive Yeztugo, and they must undergo testing prior to each injection to ensure safety. Resistance to the drug may occur if an individual is infected with HIV before starting treatment or after discontinuation. The most common side effects reported include reactions at the injection site, such as pain, swelling, or redness.
Lenacapavir, previously approved by the FDA in 2022 under the brand name Sunlenca for treating multidrug-resistant HIV infections, has now been recognized as an HIV prevention drug with the brand name Yeztugo. The FDA granted it Breakthrough Therapy designation in October, which facilitates expedited development and review for drugs that demonstrate substantial improvement over available therapies. Furthermore, lenacapavir was named “2024 Breakthrough of the Year” by the journal Science, highlighting its significant impact on HIV treatment and prevention.
Lenacapavir is considered a "groundbreaking" drug as it simplifies the process of protecting oneself against HIV, potentially leading to higher adherence rates. It works by inhibiting the formation of the HIV protective coating, known as the capsid, preventing the production of new viral particles. Monica Gandhi, medical director of the HIV Clinic at Ward 86, explains that this action effectively stops the virus from establishing itself in the body and halts viral replication.
During the initial administration of lenacapavir, patients must take two oral doses—one at the clinic and another the following day—to ensure adequate drug levels for protection within the first four days. Subsequent doses are administered every six months, offering greater flexibility and adherence compared to daily pills.
Experts believe that Yeztugo could further decrease the spread of HIV in the U.S. The estimated number of new HIV infections in 2022 was 31,800, reflecting a 12 percent decrease since 2018, as reported by the Centers for Disease Control and Prevention (CDC). Increased prescriptions of PrEP, along with improved viral suppression and HIV testing, likely contributed to this decline. The CDC advocates for healthcare providers to prescribe PrEP to anyone requesting it, including sexually active individuals without reported risk factors.
Despite the advantages of long-acting PrEP options like Yeztugo, many individuals at risk remain unprescribed. In 2022, only one-third of those who could benefit from PrEP had been prescribed it, with disparities noted among different demographics. For instance, only 13 percent of Black individuals and 24 percent of Hispanic/Latino individuals who could benefit from PrEP were prescribed it, compared to 94 percent of White individuals.
Barriers such as cost, limited awareness of PrEP, and systemic issues including poverty and medical mistrust impede access to these life-saving medications. Although PrEP options are nearly 100% effective when used properly, adherence remains a challenge, especially for those facing housing instability or substance use issues.
Landovitz emphasizes Yeztugo as a "new powerful tool in the HIV prevention toolbox," noting that fewer annual healthcare visits could ease the burden on both patients and providers. However, the prohibitive cost remains a significant hurdle, particularly when insurance coverage may not fully support it. While most private insurance and Medicaid programs cover PrEP services without co-pays, the high price of Yeztugo is a concern for many.
Furthermore, ongoing research in HIV vaccine development is crucial to ending the epidemic. Experts like Scully believe that while preventive therapeutics like Yeztugo are vital, vaccines will also be essential in achieving a long-term solution to the HIV crisis.
