FDA Approves Lenacapavir (Yeztugo) as Twice-Yearly HIV Prevention Injection
FDA Approves Lenacapavir (Yeztugo) as Twice-Yearly HIV Prevention Injection
On June 19, 2025, the Food and Drug Administration (FDA) approved lenacapavir, marketed as Yeztugo, as the first twice-yearly injection for pre-exposure prophylaxis (PrEP) to prevent HIV infection. Previously approved in 2012 under the name Sunlenca as a treatment for HIV in individuals who no longer responded to other medications, lenacapavir’s mechanism involves targeting a protective shell HIV needs to survive, disrupting its growth and spread. Unlike most HIV drugs that work on a single stage of the virus’s life cycle, lenacapavir acts on multiple points.
The FDA approval is based on two large clinical trials. One trial involving 2,134 women showed no HIV infections among those receiving Yeztugo. In another trial with 2,179 participants, only two contracted HIV. These results demonstrate superior efficacy compared to daily PrEP pills. The drug was deemed well-tolerated, with no new safety concerns identified. This led to lenacapavir being named Science magazine’s 2024 “Breakthrough of the Year.”
Yeztugo is administered as a subcutaneous injection. The regimen begins with two injections and two tablets, followed by two more tablets the next day. Maintenance involves a single injection every six months. If an injection is delayed by more than two weeks, a weekly pill can be used for up to six months. However, if treatment is interrupted for over 28 weeks, restarting the regimen may be necessary. It is crucial to note that Yeztugo is not a cure for HIV; individuals who contract HIV while using Yeztugo will require full HIV treatment. The drug is intended for individuals who test negative for HIV; testing is required before initiating treatment and before each injection to prevent the development of drug resistance.
The most common side effects reported include headaches, nausea, and injection-site reactions. Yeztugo is intended to lower the risk of HIV infection when used as prescribed, in conjunction with safe sex practices such as condom use. The drug does not protect against other sexually transmitted infections.
Gilead Sciences, the manufacturer, has stated the U.S. list price for Yeztugo is $28,218 per year. While the company anticipates insurance coverage and offers financial assistance programs, the accessibility of Yeztugo to the broader population remains uncertain. Gilead has also initiated efforts to increase global access. Agreements with six generic drug manufacturers aim to provide low-cost versions of the drug to 120 countries, primarily in Africa, Southeast Asia, and the Caribbean. The company plans to supply 2 million people in these regions with Yeztugo at no profit until generic versions become available.
The context of this approval is significant considering the ongoing HIV epidemic. Over 30,000 new HIV infections occur annually in the U.S., and approximately 1.3 million new infections are reported globally each year. Currently, only about 400,000 Americans utilize some form of PrEP. Studies have indicated a correlation between increased PrEP use and decreased HIV infection rates. A study in South Africa and Uganda involving over 5,300 young women and adolescent girls showed no HIV infections in the lenacapavir group, compared to approximately 2% in the daily pill group. Another study demonstrated similar efficacy in gay and gender-nonconforming individuals in the U.S. and other high-burden countries.
In conclusion, the FDA approval of Yeztugo represents a significant advancement in HIV prevention. However, the long-term impact will depend on factors such as accessibility, affordability, and widespread adoption among at-risk populations. Further research and public health initiatives will be crucial in maximizing the potential of this new tool in the fight against HIV.
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