FDA approves twice-yearly shot of Gilead drug for HIV prevention

The Food and Drug Administration has approved a new way to prevent HIV, clearing a Gilead Sciences drug that requires only two injections a year to protect against infections. 

The treatment, known scientifically as lenacapavir and to be sold as Yeztugo, was approved on Wednesday to reduce the risk of sexually acquired HIV infections in adults and adolescents who weigh at least 35 kilograms and are at risk of acquiring the disease.  

“This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic,” said Gilead chairman and CEO Daniel O’Day, in a statement.

Yeztugo will have a list price of $28,218 per year, slightly higher than the $26,400 yearly cost for one of its other medicines for HIV prevention, Descovy.

Gilead’s drug has already been available since 2022 as Sunlenca. That approval, however, was only for people in the U.S. whose HIV infections can’t be controlled by existing treatments. 

Since then, Gilead has tested the therapy in a pair of large studies evaluating whether it could prevent HIV in people at risk of infections. One trial enrolling 5,300 cisgender women and comparing Yeztugo to the once-daily pill Truvada and background HIV infection rates turned up zero infections — results so striking the study was stopped early. The other test, which included a broader study population, showed Yeztugo reduced infections by 96% when compared to background rates and by 89% when compared to Truvada.

Those findings have given Gilead the chance to build on its core HIV business, a bundle of treatments and preventive therapies led by multibillion-dollar seller Biktarvy. It also positions Gilead to try to upend the pre-exposure prophylaxis, or “PrEP” market currently dominated by pills. 

Gilead already sells two of these oral PrEP medicines, Truvada and Descovy. But its executives hope that a twice-yearly shot could improve uptake and adherence. The company has predicted that the PrEP market in the U.S. will grow from 400,000 people to more than 1 million by the middle of next decade and that it expects to hold more than 60% of it. That type of performance will be important to Gilead’s future, as Biktarvy, which accounted for 45% of its product sales last year, will lose patent protection in 2033.

Yeztugo is only one of a few drugs Gilead is counting on to hit that projection, as the company is developing longer-lasting pills as well as a yearly form of Yeztugo. But it could also be the most impactful. In a research note last month, Mizuho analyst Salim Syed noted Yeztugo could “redefine the PrEP market” and projected it could reach $8 billion in peak yearly sales. “[Wall Street] historically has vastly underestimated Gilead’s HIV launches,” Syed wrote. Consensus estimates have the drug generating $4 billion to $5 billion annually at its peak.

Daina Graybosch, an analyst with Leerink Partners, added last December that Gilead’s projections appear “attainable, because [Yeztugo] is an exceptional product.”

Yet Gilead faces uncertainty. Graybosch noted, for instance, that the company needs to succeed in building a market for Yeztugo partly through “direct-to-consumer engagement” and “societal destigmatization of HIV.” Brian Abrahams, of RBC Capital Markets, also cautioned in a note last November that Wall Street’s high expectations fail to account for pushback from insurers and “lower-than-warranted interest” among people at risk of contracting the virus. 

Investors “still seem overly optimistic,” Abrahams reiterated in a separate note in June. 

Gilead has fueled that optimism. At an investor conference last week, CEO O’Day called Yeztugo “potentially the best tool yet in bending the incidents in the arc of the HIV pandemic in this country and globally.”

“The community, the awareness of this amongst prescribers and the community is very, very high,” O’Day said. “We are poised now to kind of bring this advancement to more and more people,” he added. “We believe we can really grow that population.”

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