What is lenacapavir?
Lenacapavir is a first-in-class, long-acting HIV capsid inhibitor. It works by interfering with multiple stages of the HIV lifecycle, offering a different mechanism compared to many other antivirals that target a single stage. This unique mode of action allows for a less frequent dosing schedule, providing a long-lasting treatment or prevention option.
Dual FDA Approvals in the US
Lenacapavir has received two distinct approvals from the U.S. Food and Drug Administration (FDA) for different uses, each with its own brand name.
Lenacapavir for HIV Treatment (Sunlenca)
The first approval was on December 22, 2022, under the brand name Sunlenca. This is for the treatment of heavily treatment-experienced adults with multidrug-resistant HIV-1 who are not responding to their current antiretroviral therapy. In this case, lenacapavir is used alongside other antiretroviral medications and was approved based on data showing viral load reduction in patients with limited treatment choices.
Lenacapavir for HIV Prevention (Yeztugo)
A second FDA approval was granted on June 18, 2025, for HIV pre-exposure prophylaxis (PrEP) under the brand name Yeztugo. This long-acting injectable is for adults and adolescents who weigh at least 77 pounds (35 kg) and are at risk of sexually acquired HIV-1. This approval was based on the high efficacy demonstrated in preventing HIV infection in the PURPOSE 1 and PURPOSE 2 trials. The injectable for PrEP is intended to improve adherence and simplify prevention for many individuals.
Administration and Patient Access
Accessing lenacapavir involves a specific administration schedule, and manufacturer programs are available to help with costs.
Dosing and Administration
Both Sunlenca and Yeztugo require an initial oral dose followed by subcutaneous injections administered by a healthcare professional. Following the schedule provided by the healthcare provider is important for effectiveness and to prevent drug resistance.
Cost and Patient Assistance
Lenacapavir has a high list price, but Gilead offers programs to help patients with the cost.
- Commercially insured individuals: The Gilead Advancing Access Co-pay Savings Program may help reduce out-of-pocket expenses.
- Uninsured individuals: Eligible patients without insurance might receive lenacapavir free through the Gilead Advancing Access medication assistance program.
- Insurance coverage: Coverage for lenacapavir can vary depending on the insurance plan and may be subject to evolving regulations and policies.
Comparison of PrEP Options
Lenacapavir (Yeztugo) is a new PrEP option compared to existing methods. The table below outlines key differences:
| Feature | Lenacapavir (Yeztugo) | Daily Oral PrEP (e.g., Truvada) | Bi-monthly Injectable PrEP (e.g., Apretude) |
|---|---|---|---|
| Dosing Frequency | Administered by injection according to a schedule | Once daily via oral pill | Every two months via injection |
| Primary Benefit | High efficacy with less frequent dosing, improving adherence | Long track record of use and generally affordable with insurance | Less frequent than daily pills, potentially improving adherence |
| Potential Challenges | High list price, potential for injection site reactions | Requires daily adherence, which can be challenging for some | More frequent injections than lenacapavir, requires provider administration |
| Administration Method | Subcutaneous injection, administered by a healthcare provider | Oral tablet, taken by the patient | Intramuscular injection, administered by a healthcare provider |
The Significance of Long-Acting Lenacapavir
The long-acting nature of lenacapavir provides several important benefits:
- Enhanced Adherence: The less frequent schedule can significantly improve adherence by reducing the frequency of administration compared to daily pills or bi-monthly injections.
- Overcoming Stigma: Less frequent dosing may help reduce the stigma some individuals associate with taking daily medication for HIV or PrEP.
- Expanded Options: Offering diverse PrEP and treatment choices can cater to individual needs and preferences, enhancing overall HIV prevention and care strategies.
Conclusion
To definitively answer, is lenacapavir available in the US? yes, it is, for two distinct uses. It is approved as Sunlenca for treating heavily treatment-experienced, multi-drug resistant HIV and as Yeztugo for HIV prevention (PrEP). The introduction of an injectable medication with a less frequent administration schedule is a significant advancement in HIV care, offering a powerful new tool for both treatment and prevention that could improve adherence and public health. Individuals interested in lenacapavir should consult a healthcare provider, and Gilead's Advancing Access programs are available to assist with cost and coverage. Ongoing efforts in developing and distributing such medications highlight the continued progress in addressing the HIV epidemic.
For additional information on the guidelines for using antiretroviral agents, consult the resources from the U.S. Department of Health and Human Services.
