Lenacapavir for PrEP will face major implementation challenges

The new year will begin with an expanded HIV prevention landscape with the addition of lenacapavir as a long-acting, injectable form of pre-exposure prophylaxis (PrEP). Approved in June of 2025, and requiring two injections per year, lenacapavir represents a significant advancement in biomedical HIV prevention. However, its approval comes at a challenging time for HIV prevention, with federal cuts to HIV prevention programming, Medicaid and public health at large looming over 2026. Moreover, at a list price of approximately $28,000 per year ($14,000 per injection), and without a United States Preventive Services Taskforce requirement for insurance coverage, this new and promising addition to our prevention toolkit is poised to face significant implementation challenges. By extension, its ability to reach those who could benefit most from the convenience of a twice-a-year injectable form of PrEP is likely to be meaningfully undermined. HIV prevention advocates and implementation scientists will be focusing their attentions on these urgent implementation challenges within the broader context of a challenging political climate.

—Alexa B. D’Angelo, Ph.D., M.P.H.

Postdoctoral fellow, CUNY Institute for Implementation Science in Population Health

HIV funding cuts will undermine prevention efforts

After a year of regressive policy and funding proposals by the Trump administration and House Republicans, the U.S. and communities around the world are likely to see serious backtracking on global and national targets to end HIV as an epidemic. Modeling indicates that ongoing efforts to disrupt PEPFAR funding, particularly for HIV prevention services, could contribute to 10 million new HIV infections globally in the next five years, including one million new infections among children. Within the U.S., House proposals to slash $1.7 billion from federal HIV funding threaten to further destabilize our national response networks, while major disruptions to Medicaid and ACA tax subsidies will disproportionately impact healthcare access for people living with and vulnerable to HIV. Although a newly FDA-approved six-month injectable HIV prevention shot, lenacapavir, has provided much-needed hope in the face of these challenges, the $28,000 list price in the US will severely limit its impact on the domestic epidemic. And while we are seeing improved dissemination globally compared to previous preventive innovations, several key countries have been left out of plans for introduction. It’s unclear if promises by the Trump administration to facilitate global access to lenacapavir can overcome overall disruptions to U.S. HIV funding. One question will be whether we can reliably see the impact of these policy choices, as we see signs that the administration is delaying and disrupting important HIV surveillance activities. And, of course, with HIV advocates redoubling efforts to push back, there is always hope that the worst funding cuts and associated outcomes can be averted.

—Jeremiah Johnson

Executive director, PrEP4All, co-founder of the Save HIV Funding campaign