A groundbreaking HIV prevention shot has just been approved by the U.S. Food and Drug Administration (FDA), and it only needs to be taken twice a year. The injectable drug, lenacapavir, sold under brand names like Yeztugo and Sunlenca, offers near-total protection against HIV.
For millions of people who struggle with daily pills or frequent clinic visits, this long-acting option could change the game.
What Is Lenacapavir?
Lenacapavir is a long-acting HIV prevention injection. Unlike daily PrEP (pre-exposure prophylaxis) pills, which must be taken every day, this shot stays in the body for six months, offering continuous protection.
In clinical trials, lenacapavir was nearly 100% effective at preventing new HIV infections. This marks a major breakthrough in HIV prevention, especially for communities where daily medication isn't realistic or accessible.
Why Is This Shot a Game-Changer?
- Only Two Doses a Year: No more daily reminders. Just two shots annually make adherence easier.
- Higher Effectiveness: In trials, no one who got the shot contracted HIV. Some people taking daily pills still do.
- Better Access for Some: People who struggle with daily meds, doctor visits, or live in underserved areas can now have a simpler option.
Today, about 500,000 Americans use PrEP pills, while around 21,000 use Apretude, a bimonthly injectable option. With its twice-a-year schedule, lenacapavir could dramatically increase prevention coverage.
Who Stands to Benefit Most?
Lenacapavir could help a wide range of people, including:
- Individuals at high risk of HIV, such as those with HIV-positive partners.
- Young women and girls in Sub-Saharan Africa who were key participants in successful clinical trials in South Africa and Uganda.
- People in underserved communities who face obstacles to daily treatment or regular healthcare.
What Are the Challenges?
Despite its promise, lenacapavir’s rollout faces hurdles:
- High Cost: It currently costs over $40,000 for the first year. However, experts say the price could drop to $40 per dose with large-scale production.
- Access Gaps: Funding cuts in global HIV programs could limit the shot's reach in low-income countries, where the need is often greatest.
- Health Inequities: In the U.S., Black Americans account for 39% of new HIV cases but make up just 14% of PrEP users, often due to stigma, lack of insurance, and systemic barriers.
“100-percent effectiveness demands 100-percent access,” says Asia Russell of Health GAP, stressing the urgency of equitable distribution.
How Does This Fit Into HIV Prevention?
Lenacapavir joins a growing list of HIV prevention tools:
- Condoms: Still effective when used properly.
- PrEP Pills: Taken daily before exposure.
- PEP: Taken after potential exposure, within 72 hours.
- Long-Acting Shots: Like lenacapavir, offering long-term protection with minimal effort.
The new shot doesn’t replace existing methods but adds another powerful choice for those who need flexibility.
What’s Next?
Gilead Sciences, the company behind lenacapavir, is working with governments, health organizations, and advocacy groups to:
- Raise awareness about the shot.
- Secure funding to improve affordability.
- Expand access in high-need regions.
Meanwhile, the World Health Organization (WHO) is preparing to release official guidelines on how countries can best implement this new prevention tool.
Final Thought: A New Era in HIV Prevention
With nearly 100% protection and just two shots per year, lenacapavir could redefine how the world approaches HIV prevention. But for its full potential to be realized, leaders must act quickly to ensure affordable access for all, regardless of race, income, or geography.
