• The World Health Organization has globally endorsed lenacapavir, an effective semi-annual injection for HIV prevention.

  • This endorsement comes shortly after the U.S. FDA approved the medication, which will be marketed as Yeztugo in the United States.

  • In clinical trials, this biannual injection proved almost completely effective, potentially enhancing adherence over other PrEP options.

  • While there is optimism about lenacapavir’s role in preventing HIV, concerns about its cost and accessibility persist.

A medication previously used for treating certain HIV infections has now been approved for preventive use against HIV, the virus responsible for AIDS.

The World Health Organization has globally recommended lenacapavir, a semi-annual injection aimed at preventing HIV infections, especially among high-risk populations and areas with high transmission rates.

This recommendation was made public on July 14 during the International AIDS Conference held in Kigali, Rwanda, following the recent approval of lenacapavir by the Food and Drug Administration (FDA) for preventing HIV in adults and adolescents.

Developed by Gilead Sciences, lenacapavir (Yeztugo) has significantly lowered the risk of HIV infection in two phase 3 clinical studies funded by the manufacturer.

The studies, named PURPOSE 1 and PURPOSE 2, inclusively showed that 99.9% of participants who were administered lenacapavir remained HIV negative. The most common side effects reported were pain and swelling at the injection site.

Lenacapavir has demonstrated superior protection against HIV compared to existing PrEP methods, earning it the title of “Breakthrough of the Year” by Science magazine in 2024.

In the U.S., PrEP has been available since 2012, typically involving daily oral pills (Truvada) or bi-monthly injections (Apretude).

The introduction of Yeztugo, a biannual injection, presents a new, effective option for those considering PrEP, marking the first such long-term preventative solution in the U.S.

The FDA’s approval of this preventive therapy represents a significant development amidst recent cuts in federal funding for HIV vaccine research and support for clinical guidelines on HIV treatment.

Carlos del Rio, MD, from Emory University, highlighted the potential of Yeztugo in enhancing PrEP adoption and persistence, calling it a crucial addition in efforts to end the HIV epidemic.

He also noted that a semi-annual injection could significantly reduce adherence issues and stigma associated with more frequent PrEP regimens.

Enhanced Adherence with Biannual PrEP

In 2023, over 100 people were diagnosed daily with HIV in the United States, according to the CDC.

The CDC also found that while up to 2.5 million Americans could benefit from PrEP, only a fraction are currently prescribed such treatments.

Despite widespread availability, PrEP is underutilized in the U.S. due to factors like stigma and issues with affordability, insurance, or access, particularly affecting minority communities in the Southern states.

Experts believe that a highly effective, semi-annual PrEP option could improve access and adherence, especially for uninsured individuals.

According to Monica Gandhi, MD, MPH, from the University of California, San Francisco, the approval of lenacapavir is promising, as shown in its effectiveness in large trials among both women and men.

Gandhi, who was not involved in the trials, shared that clinics serving low-income populations have seen success with long-acting PrEP, which helps those struggling with daily adherence due to various challenges.

She anticipates that Yeztugo could see similar or better adherence rates, appealing to those who prefer less frequent dosing.

Biannual PrEP: A Potential Revolution in HIV Prevention

In the U.S., high-risk groups for HIV include men who have sex with men and heterosexuals with multiple partners.

The need for accessible HIV prevention like PrEP is a global issue.

Gilead reports that regulatory bodies worldwide are considering Yeztugo for HIV prevention, with the U.S. being the initial country to approve it.

William Schaffner, MD, from Vanderbilt University, expressed high confidence in the drug’s potential to drastically change HIV prevention.

He believes that, with sufficient determination and resource allocation, this method could effectively prevent HIV on a large scale, not only in developed nations but also in developing regions.

Challenges Ahead for a Promising Prevention Option

The timeline for when Yeztugo will be widely available in the U.S. and its cost, especially for the uninsured, remains uncertain.

Schaffer discussed the need for time to educate healthcare providers on Yeztugo’s benefits and for insurance programs to incorporate it into their coverage.

Gandhi raised concerns about the drug’s high cost, questioning whether major insurance providers would cover it.

A Gilead representative stated that lenacapavir might cost approximately $28,218 per year per person in the U.S.

The company is striving to ensure that Yeztugo is accessible to all who need it, anticipating widespread insurance coverage.

Gandhi noted that this price is in line with other long-acting PrEP therapies and stressed the importance of making the medication accessible, especially amidst potential significant healthcare budget cuts in the U.S.