Tag: Yeztugo

A significant advancement in HIV prevention has arrived with the FDA approval of Yeztugo® (lenacapavir), the first and only injectable HIV prevention shot requiring administration just twice a year. This long-acting medication offers powerful protection without the daily commitment of oral PrEP, addressing barriers that have historically limited access, particularly for Black and Brown communities, women, and individuals in the Southern U.S.

What is Yeztugo® and Who Can Take It?

Yeztugo® is a long-acting injectable medication designed to significantly reduce the risk of acquiring HIV infection. It is intended for individuals who do not currently have HIV but are seeking protection, whether they are new to PrEP or considering switching from daily oral medications. The medication is suitable for adults and adolescents weighing at least 77 pounds (approximately 35 kg) who are at higher risk for HIV, including those who have engaged in condomless sex, experienced a recent STI, or have a partner living with HIV.

Why This Approval Matters Now

Despite the availability of PrEP since 2012, HIV diagnoses remain a concern in the U.S., with over 100 new infections daily in 2023. PrEP usage is notably underutilized among key populations, including women, Black/African American and Latine/Hispanic individuals, and those residing in the U.S. South. Yeztugo®’s twice-yearly format offers a discreet and potentially more manageable option, which could significantly improve adherence and protection rates for these communities. Its potential impact has been recognized globally, with the journal Science naming lenacapavir (the active drug in Yeztugo®) its 2024 “Breakthrough of the Year.”

Proven Efficacy and Inclusive Research

Clinical trials have demonstrated remarkable efficacy for Yeztugo®. In two large global studies, PURPOSE 1 and PURPOSE 2, over 99.9% of participants receiving Yeztugo® remained HIV-negative. The PURPOSE program itself is noted as the most inclusive HIV prevention clinical trial program ever conducted, with a specific focus on Black women, LGBTQ+ individuals, and communities in Africa and Latin America, ensuring the research was conducted “for us and with us.”

How Yeztugo® Works and Potential Side Effects

Yeztugo® works by blocking HIV at various stages of its life cycle, preventing it from taking hold in the body. The initial administration involves two pills and two injections on Day 1, followed by two more pills on Day 2. Subsequently, individuals receive two injections every six months at a clinic or doctor’s office. Clinical trials indicated that Yeztugo® was generally well-tolerated, with the most common side effects being injection site soreness, headache, and nausea. Importantly, the twice-yearly format eliminates the daily reminder and potential stigma associated with keeping bottles of medication visible, offering a discreet and convenient solution.

Cost and Accessibility

Gilead, the manufacturer of Yeztugo®, states that the medication will be priced comparably to other branded PrEP medications. For uninsured individuals, the Gilead Advancing Access program may provide free medication. Copay assistance is also available, encouraging individuals not to assume affordability is a barrier. More information can be found at www.yeztugo.com.

Is Yeztugo® Right for You?

Yeztugo® could be a suitable option for individuals who are not living with HIV, desire a simpler and more discreet method of protection, prefer injections over daily pills, or engage in activities that increase HIV risk, particularly when condom use is inconsistent. It is essential to undergo an HIV test before each injection, a process typically managed by a healthcare provider.

Currently approved in the U.S. and the European Union’s 27 member states, plus Norway, Iceland, and Liechtenstein (under the brand name Yeytuo®), Gilead is working to make Yeztugo® available in more countries, including South Africa, Brazil, and Canada. This expansion signifies a global commitment to providing diverse HIV prevention options.