Gilead’s twice-yearly injectable PrEP gets FDA approval

USA—Gilead Sciences has announced a major breakthrough in HIV prevention with the U.S. Food and Drug Administration (FDA) approval of Yeztugo® (lenacapavir), the first and only twice-yearly injectable pre-exposure prophylaxis (PrEP) for HIV-1.

This new medication is designed to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35 kg (about 77 pounds), offering a convenient alternative to daily oral PrEP options currently available in the United States.

Yeztugo’s approval is based on robust data from two Phase 3 clinical trials, PURPOSE 1 and PURPOSE 2, which showed that 99.9% or more of participants receiving the twice-yearly injection remained HIV negative.

In the PURPOSE 1 trial, which involved over 2,100 cisgender women in sub-Saharan Africa, there were zero HIV infections among those treated with Yeztugo, demonstrating 100% efficacy compared to daily oral Truvada.

Similarly, the PURPOSE 2 trial, involving more than 2,100 cisgender men and gender-diverse individuals globally, showed a 99.9% efficacy rate, with only two infections reported in the Yeztugo group.

Daniel O’Day, Gilead’s Chairman and CEO, described the FDA approval as a historic moment in the fight against HIV, highlighting that Yeztugo’s twice-yearly dosing could transform HIV prevention by improving adherence and access.

He emphasized that Gilead’s scientists have dedicated their careers to ending HIV, and this approval brings them closer to that goal.

Despite the availability of PrEP since 2012, uptake in the U.S. remains low.

Data from the Centers for Disease Control and Prevention (CDC) show that only about 36% of people eligible for PrEP were prescribed it in 2022.

 Barriers such as daily pill adherence challenges, stigma, and low awareness among both healthcare providers and patients have limited broader use.

Yeztugo’s twice-yearly injection aims to overcome these obstacles by reducing the frequency of dosing and potentially lowering stigma associated with daily medication.

Experts like Dr. Carlos del Rio from Emory University have praised Yeztugo as a transformative option that could increase PrEP uptake and persistence.

The biannual injection addresses key barriers faced by individuals on daily oral PrEP, such as adherence difficulties and stigma, and aligns with research showing many prefer less frequent dosing.

Gilead is working to ensure broad insurance coverage and affordability for Yeztugo in the U.S. through partnerships with insurers and assistance programs that can reduce out-of-pocket costs to zero for eligible patients.

The company is also pursuing regulatory approvals in other countries, including submissions to the European Medicines Agency and authorities in Australia, Brazil, Canada, South Africa, and several Latin American nations.

Yeztugo’s approval marks a significant advancement in HIV prevention, offering a highly effective, convenient option that could help reduce new HIV infections, which still occur at a rate of over 100 diagnoses per day in the U.S. alone.

While there is currently no cure for HIV or AIDS, innovations like Yeztugo provide new hope in the ongoing effort to end the epidemic.

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