A New Era Against HIV with Yeztugo: 6 Months of Protection from a Single Dose

Approved by the FDA on 18 June 2025, Yeztugo (lenacapavir) marked an important milestone in medical history as the first and only drug administered every 6 months to provide protection against HIV. Developed by Gilead Sciences, this new-generation HIV prevention treatment offers a powerful solution to the risk of HIV transmission through its long action and high clinical success rate. Revolutionary for both users and healthcare systems, Yeztugo opens a new chapter in public health.

What Is Yeztugo?

Yeztugo (active ingredient: lenacapavir), an HIV-1 capsid inhibitor, is a preventive (PrEP) drug. In adults and adolescents weighing at least 35 kg, it provides protection against sexually acquired HIV-1 infection.

Yeztugo is the world’s first approved HIV prevention treatment administered every 6 months.

Strong Protection Supported by Clinical Evidence

Yeztugo’s FDA approval is based on Gilead’s trials, among the world’s largest HIV prevention studies, PURPOSE 1 and PURPOSE 2 , both Phase 3 clinical trials:

PURPOSE 1 (cisgender women – sub-Saharan Africa):

• 0 HIV infections – 100% protection rate
• Compared with daily Truvada, superior success

PURPOSE 2 (cisgender men and gender-diverse individuals):

• 2 infections / 2,179 participants
• 99.9% remained HIV-negative
• Compared with Truvada and background HIV rates, superior prevention

Results of both studies were published in the New England Journal of Medicine. Lenacapavir was also named Science magazine’s 2024 ‘Breakthrough of the Year’.

How Is It Used?

Yeztugo is administered in both tablet and injection forms. Administration must be performed only by healthcare personnel.

The regimen is as follows:

Initiation:

Day 1:

• 2 injections (927 mg total) + 600 mg oral tablets

Day 2:

• 600 mg oral tablet

Continuation:

• Every 6 months, subcutaneous injection (927 mg)

If an interim dose is missed or delayed, oral tablets may temporarily be used as bridging treatment.

Safety and Warnings

Yeztugo is one of the drugs carrying an FDA “Boxed Warning” (a black-box warning). This highlights critical safety considerations:

• It must not be started without HIV testing.
• In individuals with active HIV infection, drug resistance may develop.

Adverse effects:

• The most common are injection-site reactions, headache and nausea.
• Rarely, serious injection-site reactions (tissue damage) may occur.

Drug interactions:

Use cautiously with CYP3A inducers or inhibitors.

Global Access Strategy

Gilead has initiated regulatory processes in the European Union (EMA), Canada, Australia, South Africa and Latin American countries to make Yeztugo available worldwide as well as in the US.

In addition, Gilead’s Advancing Access® programaims to provide Yeztugo free of charge to uninsured individuals.

Why Is Yeztugo an Important Development?

• Revolutionary for people experiencing adherence problems
• Reduces concerns about privacy and stigma
• Provides convenience and sustainability through administration every 6 months
• Has the potential to reduce the financial burden on healthcare systems

Conclusion: A New Era in HIV Prevention

Yeztugo represents a major step in the global fight against HIV. With its enhanced protection rate, long duration of action and user-friendly administration protocol, it has the potential to improve individuals’ quality of life while reducing HIV transmission in the community.