The Promise of Lenacapavir in the Current Era

In the last month alone, HIV prevention advocates have had much reason for hope and celebration with the advancement of lenacapavir, the longest-acting injectable PrEP to date, requiring an injection just once every 6 months. Bipartisan support for longer acting injectable forms of PrEP is hitting its stride.

The Centers for Disease Control and Prevention (CDC) recently published an article establishing that lenacapavir is “a highly recommended, additional option for HIV prevention and a significant step forward for the 2.2 million Americans that could benefit from PrEP.”¹ This CDC action includes new clinical recommendations for lenacapavir, which will lead to increased comfort for pproviders in the United States to prescribe it to their patients.

CDC’s guidelines follow the FDA’s action granting marketing approval in June for lenacapavir (Yetzugo) by Gilead Sciences.² And based on policy enacted during the Biden administration, the Office of Personnel Management has mandated coverage for all forms of PrEP, including long-acting injectables, in Federal Employee Health Benefits starting with the 2026 plan year.³ Just weeks ago, the State Department announced a major partnership⁴ guaranteeing the provision of lenacapavir for global distribution and more recently, the State Department’s new Global Health Strategy⁵ highlights the Department’s prioritization of lenacapavir. All of these are recent wins. All of this is incredible, especially at a time when public health advocates are running on defense on many other issues.

And also, we should critically analyze how these important wins fit into the current political context of HIV prevention domestically and globally. At the same time that the Trump administration has advanced longer-acting injectable PrEP, they have eviscerated PEPFAR and its global infrastructure, cancelled countless HIV research grants at National Institutes for Health, fired the top CDC and NIH HIV scientists, eliminated the CDC/HRSA HIV Advisory Council, and gutted the HHS Office of Infectious Disease and HIV Prevention. The President signed an executive order attacking and defunding evidence-based harm reduction programs that are proven to stop the spread of HIV. And this administration has not named anyone to the two critical HIV leadership posts as Global AIDS Coordinator or Director of the Office of National HIV/AIDS Policy. It remains unclear whether anyone will be named to either post.

HIV prevention doesn’t exist in siloes. The availability of longer-acting injectables like lenacapavir should be widely celebrated. And the many other destructive policies that have been implemented by the Trump administration should be called out for what they are: bull-in-a-china-shop approaches to downsizing the government that will lead to a worsened HIV crisis.

What’s more, the availability of lenacapavir requires that patients who need it can access it. Current policies in place at 2 federal agencies are supposed to require coverage for all forms of PrEP, but this has already been a challenge for the bimonthly injectable that has been on the market for four years. With a cost of more than 20 times that of generic oral PrEP, some insurers have created arbitrary barriers to care, including requirements that patients take oral PrEP for six months before they will cover the cost of injectables. This is not in compliance with current Federal rules, but it hasn’t stopped insurers from playing hard-to-get when it comes to coverage for injectable PrEP. And this is already being tested today with lenacapavir. 64 LGBTQI+ and HIV movement organizations led by the HIV+Hepatitis Policy Institute⁶ recently called out CVS Health for not covering lenacapavir. Advocacy organizations will be busy fighting insurers to guarantee already-required coverage for patient access to all forms of PrEP, despite clearly-written Federal rules.

Multiple modalities of HIV PrEP allows for patients and their providers to talk through side effects and adherence challenges and to decide upon the best medical option for a specific patient to prevent seroconversion. Cost shouldn’t be a deciding factor on which modality of PrEP will work best for that patient. That’s why the Biden administration advanced policies that the Trump administration has maintained requiring coverage for all forms of PrEP without cost-sharing.

The promise of lenacapavir is here, and this is a welcome advancement in the toolkit of options to prevent the transmission of HIV and to finally end the HIV epidemic in the United States and around the world. We all should appreciate the scientific advancements that brought us to the point of 6-month injectable forms of PrEP, and should celebrate the strong bipartisan support for lenacapavir. We should do this while continuing the fight for a robust, multi-pronged toolkit to prevent HIV.

We should not make HIV prevention a partisan issue—it is important to celebrate the Trump administration actions that are advancing availability of lenacapavir and also fiercely criticize their destruction of the global and domestic HIV prevention infrastructure. No one HIV prevention solution is perfect. We need a fully-supported toolbox of prevention modalities, including all forms of PrEP, evidence-based harm reduction strategies, treatment as prevention programs, condom distribution, comprehensive sex education, and well-funded implementing partners on the domestic and global stages. The promise of lenacapavir is not the promise of one product being added to the PrEP marketplace, but rather the promise of an era where we have many modalities of prevention available to us. Our government should support all of them.

References
1.CDC. CDC Recommends New Injectable HIV PrEP. September 18, 2025. Accessed September 26, 2025.
https://www.cdc.gov/nchhstp/director-letters/New-Injectable-HIV-PrEP
2. Yeztugo® (Lenacapavir) Is Now the First and Only FDA-Approved HIV. Prevention Option Offering 6 Months of Protection. Gilead. June 18, 2025.
Accessed September 26, 2025.
https://www.gilead.com/news/news-details/2025/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection
3. Moss K. What We Know About FEHB Coverage for plan year 2026. February 26, 2025. Accessed September 26, 2025.
https://federalnewsnetwork.com/feds-with-benefits/2025/02/what-we-know-about-fehb-coverage-for-plan-year-2026/
4.PEPFAR Commits to Distributing Breakthrough HIV Drug Lenacapavir Demonstrating American Excellence in Science and American Leadership in HIV Prevention. State Department. September 4, 2025. Accessed September 26, 2025.
https://www.state.gov/releases/the-united-states-presidents-emergency-plan-for-aids-relief/2025/09/pepfar-commits-to-distributing-breakthrough-hiv-drug-lenacapavir-demonstrating-american-excellence-in-science-and-american-leadership-in-hiv-prevention
5.America Health Global Health Strategy. State Department. September 2025. Accessed September 26, 2025.
6.HIV Groups letter to CVS Health on not covering Yeztugo.HIV+Hepatitis Policy Institute. September 18, 2025. Accessed September 26, 2025.
https://hivhep.org/testimony-comments-letters/hiv-groups-letter-to-cvs-health-on-not-covering-yeztugo/