FDA starts review of Gilead's weekly HIV pill

 The FDA has started a review of Gilead Sciences' once-weekly oral medicine for HIV pre-exposure prophylaxis (PrEP), and is due to deliver its verdict by 2nd February next year.

If approved, the oral formulation of capsid inhibitor Yeztugo (lenacapavir) will add to the options available for PrEP, which is used by people who are at risk of contracting HIV, for example because they are in a relationship with someone who is HIV-positive.

Last year, Gilead secured FDA approval for the injectable version of Yeztugo, which can be dosed just twice a year, and it sees the brand as an add-on to its daily oral PrEP medicine Descovy (emtricitabine/tenofovir alafenamide).

Sales of Descovy – which is used for both HIV PrEP and treatment – grew by nearly a third to $2.8 billion last year, but is facing competition from generics of Gilead's earlier oral therapy Truvada (emtricitabine/tenofovir disoproxil fumarate) and ViiV's two-monthly injectable PrEP Apretude (cabotegravir).

Some analysts have predicted that Yeztugo could eventually become a $4.5 billion blockbuster.

"This filing reflects Gilead's continued commitment to advancing new HIV prevention options," said Gilead's chief medical officer, Dietmar Berger.

"We are building on the established clinical profile of lenacapavir to potentially extend the impact of our long‑acting innovation into new formulations to meaningfully broaden how HIV prevention is delivered as PrEP," he added. "HIV prevention is not one-size-fits-all and, if approved, once-weekly oral Yeztugo would provide more choice for people who need or want PrEP."

If approved, the Yeztugo pill could become the first long-acting oral therapy for PrEP, reducing the burden of treatment for people who, for any reason, are unable or unwilling to use injectable alternatives.

Gilead's filing is based on the PURPOSE 1 and PURPOSE 2 trials, which showed high efficacy across diverse global populations, including cisgender women, cisgender men, and gender-diverse people.

Once-weekly treatment option on the way

Gilead is also working with MSD on a once-weekly tablet that could be used to treat people with existing HIV infection, and last week reported the results of two phase 3 trials that will be used to file for regulatory approvals.

The ISLEND-1 and ISLEND-2 trials showed that patients who switched from daily, oral therapy with Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) to a weekly pill containing lenacapavir and MSD's nucleoside analogue islatravir maintained HIV suppression at 48 weeks.

"Long-acting oral therapies represent a new wave of transformational innovation in HIV drug development, with the potential to reshape the landscape of care […] and make a meaningful difference in the lives of people living with the virus," said Gilead's head of virology, Jared Beaton.

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