Gilead's HIV-prevention drug cut infections by 96%, boosting stock

By Eleanor Laise

Trial results open door for twice-yearly shot to hit the market next year, analysts say

Gilead Sciences Inc.'s stock climbed 3% early Thursday after the company said its twice-yearly injection for HIV prevention cut infections by 96% in a late-stage trial, building the case for regulatory approval of the treatment.

Among 2,180 people receiving the injection, lenacapavir, there were only two cases of HIV, Gilead said in a release. Lenacapavir also proved superior in the trial to Gilead's once-daily Truvada, which is also used to prevent HIV infection. The Phase 3 study includes cisgender men, transgender people and gender nonbinary people in the U.S. and six other countries who have sex with partners assigned male at birth.

The results build on data from another late-stage trial, released in June, showing that lenacapavir was 100% effective in preventing HIV in cisgender women. In both trials, the strong results prompted the independent data-monitoring committee to recommend that Gilead halt the blinded phase of the study and offer lenacapavir to all trial participants.

"With such remarkable outcomes across two phase 3 studies, lenacapavir has demonstrated the potential to transform the prevention of HIV and help to end the epidemic," Gilead Chairman and CEO Daniel O'Day said in a statement. The company said it will start a series of global regulatory filings by the end of this year, and an initial launch of lenacapavir could come in 2025.

The longer-acting injection has been closely watched because it could address some challenges that come with once-daily pills for HIV prevention. "The difficulty some people can experience with taking an oral pill every day, including challenges with adherence and stigma, have hindered uptake and persistence of the standard of care for too long," blunting the impact of pre-exposure prophylaxis, or PrEP, in preventing HIV, Onyema Ogbuagu, a trial principal investigator and associate professor of medicine and pharmacology at Yale School of Medicine, said in a statement.

Lenacapavir was 89% more effective than the once-daily Truvada in the new trial, Gilead said Thursday. "This will help change the paradigm for the PrEP market in swapping patients from once-daily oral PrEP" to the longer-acting injection, Jefferies analysts said in a research note Thursday.

About 1.2 million people in the U.S. have HIV, with nearly 32,000 people infected in 2022 alone, according to federal government data. The twice-yearly injection "has the potential to be one of the most impactful interventions we could have to drive down new infections and bring us closer to ending the HIV epidemic" in the U.S., Colleen Kelley, a trial principal investigator and professor of medicine at Emory University, said in a statement.

Gilead's stock (GILD) has gained 3% in the year to date, while the S&P 500 SPX has gained 16.5%.

-Eleanor Laise

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09-12-24 1000ET

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