A New Chapter in HIV Prevention: FDA Greenlights Lenacapavir for Twice-Yearly PrEP
In a significant public health milestone, the U.S. Food and Drug Administration (FDA) has approved lenacapavir, branded as Sunlenca, as the first and only twice-yearly injectable medication for HIV prevention.
In a significant public health milestone, the U.S. Food and Drug Administration (FDA) has approved lenacapavir, branded as Sunlenca, as the first and only twice-yearly injectable medication for HIV prevention. This marks a major leap forward in the global fight against HIV, especially for communities that have struggled with daily pill regimens.
For the millions at risk of HIV, this biannual pre-exposure prophylaxis (PrEP) option offers a powerful and discreet alternative—administered just twice a year, it’s poised to improve adherence and close longstanding gaps in HIV prevention access.
What Is Lenacapavir and How Does It Work?
Lenacapavir is a capsid inhibitor, a new type of antiretroviral drug that works by disrupting the protein shell that protects the virus, preventing it from replicating inside the body. This novel mechanism not only makes it highly effective but also enables its extended duration of action—hence, the twice-yearly dosing.
Previously approved for use in individuals living with multi-drug resistant HIV, lenacapavir’s transition into the prevention space is being celebrated as a game-changer for PrEP.
Who Benefits Most from Long-Acting PrEP?
One of the major barriers in HIV prevention has been adherence to daily oral medications like Truvada or Descovy. Research shows that missing doses significantly reduces protection, especially among younger users and marginalized groups who may face stigma, limited healthcare access, or other systemic obstacles.
The simplicity of two injections per year could remove these barriers. Lenacapavir is expected to have a transformative impact on high-risk populations including:
- Black and Latino gay and bisexual men
- Transgender women
- Cisgender women in Sub-Saharan Africa
- Youth and adolescents with limited healthcare access
“This is more than just a new drug—it’s a new strategy,” said Dr. Angela Rivers, an infectious disease specialist at Emory University. “Lenacapavir could help rewrite how we reach communities that have historically been left behind.”
Clinical Trials Prove Powerful Protection
The FDA’s approval is based on early results from the PURPOSE 1 and PURPOSE 2 studies—two ongoing, large-scale clinical trials evaluating the safety and efficacy of lenacapavir as PrEP.
- PURPOSE 1, conducted in women across Sub-Saharan Africa, showed zero new HIV infections among participants receiving lenacapavir on schedule.
- PURPOSE 2 is currently evaluating the drug among gay and bisexual men, and transgender women across multiple continents.
These findings position lenacapavir as one of the most effective and low-maintenance prevention tools ever developed in the field of HIV medicine.
What About Access and Cost?
While the medical breakthrough is clear, access remains a looming question. Gilead Sciences, the manufacturer of Sunlenca, has not yet announced a final price for the PrEP version of lenacapavir. Advocacy groups are calling for affordable pricing and equitable distribution, particularly in low-income and high-incidence communities.
Public health experts emphasize that the success of lenacapavir will depend not only on its clinical efficacy but also on insurance coverage, Medicaid access, and provider training to deliver the injection safely and effectively.
How Lenacapavir Compares to Other PrEP Options
Lenacapavir is entering a growing landscape of PrEP tools, each with its own strengths:
| PrEP Option | Dosing Frequency | Method | Brand Name |
| Truvada / Descovy | Daily | Oral Pill | Truvada, Descovy |
| Cabotegravir | Every 2 Months | Injection | Apretude |
| Lenacapavir | Every 6 Months | Injection | Sunlenca |
With its twice-yearly schedule, lenacapavir is the longest-acting PrEP medication available, ideal for people who want protection without the burden of frequent dosing or clinic visits.
A Turning Point in the HIV Epidemic?
While HIV remains a global health crisis—with over 1.3 million new infections reported globally in 2023—tools like lenacapavir are reshaping the prevention landscape. Experts say long-acting PrEP could be a cornerstone in reaching the United Nations’ goal of ending the HIV epidemic by 2030.
“The approval of lenacapavir gives us real hope,” said Dr. Celeste Watkins-Hayes, a sociologist and HIV researcher. “But we must pair innovation with investment in education, outreach, and access if we want to see its full impact.”
A New Standard for Prevention
The FDA approval of lenacapavir as a twice-yearly HIV prevention injection could become one of the most impactful public health advancements of the decade. By offering convenience, privacy, and exceptional efficacy, this innovative treatment has the potential to reach individuals who have never before engaged with PrEP.
As rollout begins, all eyes will be on how health systems respond, how communities are engaged, and how pricing policies are set. Because while the science is solid, the success of lenacapavir will ultimately come down to making it available to those who need it most.
By Grace Linzerfield for Revoke.com
