Is Yeztugo Available? Access and Information on the Twice-Yearly HIV Prevention Shot

October 6, 2025 •

2 min read

Following its FDA approval in June 2025, Yeztugo (lenacapavir) became the first and only twice-yearly injectable option for HIV pre-exposure prophylaxis (PrEP) in the United States. For those asking, 'Is Yeztugo available?', the answer is yes in the United States, representing a significant advancement in HIV prevention by simplifying the dosing schedule and addressing adherence barriers.

Quick Summary

Yeztugo, the twice-yearly injectable HIV PrEP, was approved by the FDA in June 2025 and is now available in the U.S. for at-risk adults and adolescents. Its availability provides a new, highly effective, and long-lasting option for HIV prevention.

Key Points

FDA Approved: Yeztugo (lenacapavir) was approved by the U.S. FDA in June 2025 as a twice-yearly injectable for HIV prevention (PrEP).
Convenient Dosing: After an initial regimen involving both injections and oral tablets, ongoing treatment requires only two subcutaneous injections per year.
Addresses Adherence Issues: The less frequent dosing schedule is expected to improve adherence rates, a key barrier to effective HIV prevention with daily oral pills.
High Efficacy: Clinical trials demonstrated Yeztugo's high effectiveness, with a greater than 99.9% rate of preventing HIV infection in study participants.
Insurance Support: Manufacturer Gilead offers patient assistance programs to help eligible individuals with the cost, though insurance coverage details may vary.
Not Yet Global: While approved in the U.S., regulatory filings are underway in other countries, but it is not yet approved or available for PrEP outside the U.S..
Requires HIV Testing: Individuals must test negative for HIV before starting Yeztugo and before every subsequent injection to prevent drug resistance.

What Is Yeztugo?

Yeztugo is the brand name for lenacapavir, an HIV-1 capsid inhibitor developed by Gilead Sciences. It is a long-acting PrEP medication to reduce the risk of sexually acquired HIV-1 in eligible individuals. Unlike daily oral PrEP, Yeztugo is a subcutaneous injection administered twice a year. Lenacapavir is also approved as Sunlenca for treating multi-drug-resistant HIV in adults.

How Yeztugo Works

Yeztugo targets the HIV-1 capsid, disrupting the virus's lifecycle at multiple stages to prevent replication and infection. Its mechanism allows it to remain effective for months after a single dose.

Is Yeztugo Available?

Yes, Yeztugo is available in the United States after its FDA approval in June 2025. Approval was based on Phase 3 trials showing high efficacy. Specialty pharmacies and health systems began offering the medication soon after approval.

Access and Availability Considerations

Accessing Yeztugo involves several factors:

Initial Rollout: Distribution began with specific clinics and specialty pharmacies in mid-2025, with wider integration into practice ongoing.
Insurance Coverage: Most major insurance plans are expected to cover Yeztugo, potentially with prior authorization. Gilead's Advancing Access® program assists eligible patients with costs.
Global Access: Regulatory reviews are in process in countries outside the U.S., but lenacapavir for PrEP is not yet universally approved or available.

Yeztugo Administration

The administration of Yeztugo involves an initial schedule followed by ongoing injections twice a year. An initial regimen is administered over two days. After this, the medication is administered every 6 months. HIV-1 testing is required before initiating and with each injection.

Side Effects and Risks

Common side effects include injection site reactions like pain, swelling, induration, and nodules. Most reactions are mild to moderate. Other common effects are headache and nausea. A Boxed Warning highlights the risk of drug resistance if used in individuals with undiagnosed HIV-1.

Comparison of PrEP Options

Understanding different PrEP options is crucial for informed decisions. Here's a comparison:


Feature	Yeztugo (lenacapavir)	Truvada (emtricitabine / tenofovir disoproxil)	Apretude (cabotegravir)
Administration	Subcutaneous injection by provider	Oral pill	Intramuscular injection by provider
Dosing Frequency	Twice-yearly (every 6 months)	Daily	Every 2 months
Drug Class	HIV-1 Capsid Inhibitor	Nucleoside Reverse Transcriptase Inhibitor (NRTI)	Integrase Strand Transfer Inhibitor (INSTI)
Long-Acting	Yes	No	Yes
Mechanism	Disrupts HIV capsid at multiple lifecycle stages	Blocks reverse transcriptase to prevent viral replication	Blocks integrase, preventing proviral DNA from integrating into human DNA
Initial Regimen	Administered over 2 days	No lead-in required	Initial loading doses over 1-2 months

Conclusion: A New Era for HIV Prevention

The approval and availability of Yeztugo are significant advancements in HIV prevention. Its twice-yearly dosing addresses adherence challenges with daily oral PrEP. This convenience and high efficacy offer a new tool for providers and at-risk individuals. While early access and global rollout continue, Yeztugo presents a promising option to increase PrEP uptake and help end the HIV epidemic.

For more information on HIV prevention, consult the CDC website. The CDC recommended Yeztugo in new guidelines in September 2025.

Frequently Asked Questions

Yes, Yeztugo is available in the United States following FDA approval in June 2025. Initial availability began shortly after approval, with continued rollout through specialty pharmacies and health systems.

After the initial regimen, Yeztugo is given as a subcutaneous injection twice per year (every six months) by a healthcare provider.

No, Yeztugo is not approved for HIV treatment. It is specifically for HIV prevention (PrEP) in HIV-negative individuals. The same active ingredient, lenacapavir, is approved for HIV treatment under a different brand name, Sunlenca.

Yeztugo is indicated for HIV-1 pre-exposure prophylaxis in adults and adolescents weighing at least 35 kg who are at risk for sexually acquired HIV-1 infection. Eligibility is determined by a healthcare provider after confirming an HIV-negative status.

Common side effects include injection site reactions, such as pain, swelling, and nodules, which are lumps under the skin that may last for several months but are typically not harmful.

If a scheduled injection is delayed, a healthcare provider should be consulted immediately. Patients may temporarily switch to oral tablets for a period, but restarting the full initiation dose may be necessary if too much time passes.

Yes, major insurance providers are expected to cover Yeztugo, though specifics can vary by plan and require provider navigation. The manufacturer, Gilead, also offers patient assistance programs to reduce out-of-pocket costs for eligible individuals.