Archive · 21 Jun 2025
FDA Approves Twice-Yearly HIV Shot; Access Concerns Arise
Imagine a new way to prevent HIV, a shot you only need twice a year!
The FDA just approved a medicine called lenacapavir, sold as Yeztugo, for this.
It works really well, almost perfectly, in stopping HIV.
It's for people at risk of getting HIV who might not always take pills every day.
Right now, many people take a daily pill to prevent HIV.
The new shot is more convenient, but it is expensive.
A big worry is if everyone who needs it will be able to afford it, especially in poorer countries.
The medicine is getting ready to go to many places around the world, but it will take some time to reach everyone who needs it.
The FDA approved a twice-yearly HIV prevention shot, lenacapavir, marketed as Yeztugo.
Lenacapavir showed nearly 100% effectiveness in clinical trials for HIV prevention.
The shot is an alternative to daily pills and monthly injections for people at high risk.
The annual list price for Yeztugo is $28,218, raising affordability concerns.
Global rollout of lenacapavir in low- and middle-income countries may take years.
- Who
- The FDA approved the drug manufactured by Gilead Sciences.
- What
- The FDA approved lenacapavir, a twice-yearly HIV prevention shot.
- When
- The FDA approved lenacapavir.
- Where
- The U.S.
- Why
- To provide an alternative HIV prevention method for those at high risk, potentially improving adherence.
Advocates
Pharmaceutical Companies
Affordability and Access
Advocates
They are concerned about the high price of the new drug, potentially limiting access.
Pharmaceutical Companies
Gilead is working with global health agencies to ensure wider access.
Funding and Support
Advocates
Cuts to Medicaid and federal HIV programs may affect availability.
Pharmaceutical Companies
Gilead is working with global health agencies to ensure wider access.
- Drug Name
- Lenacapavir (Yeztugo)
- Administration
- Twice-yearly injection
- Manufacturer
- Gilead Sciences
- Target Group
- Individuals at high risk of HIV
- Effectiveness
- Nearly 100% in trials
- Annual Cost
- $28,218
- Current PrEP Users (US)
- ~500,000 (daily pills)
- Global New HIV Infections (2023)
- 1.3 million