Gilead’s Twice-a-Year HIV Prevention Shot Wins FDA Approval

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(Bloomberg) — Gilead Sciences Inc. said it won US approval for a drug to prevent HIV that only has to be given twice a year, making it a convenient new way to ward off infection in a wide range of people.

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In two big international studies published last year, the medicine demonstrated a powerful ability to avert HIV infection. With no vaccine on the horizon, the ultra-long acting shot has been hailed by activists as perhaps the best tool the world has so far to wipe out the virus.

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Shares of Gilead briefly jumped as much as 3.5%, their biggest gain in almost a month. The stock had risen 17% this year through Tuesday, compared with a 2% increase in the S&P 500 index.

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The medicine will be marketed as Yeztugo, Gilead said. Even as it works to make the drug a best-seller in rich countries like the US, the Foster City, California-based company will face great pressure to rapidly roll it out for poor and middle income countries that have been hit hard by HIV. 

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“This is a milestone moment in the decades-long fight against HIV,” Gilead Chief Executive Officer Daniel O’Day said in an emailed statement.  “We now have a way to end the HIV epidemic.”

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The approval and rollout of the drug will being closely watched by Wall Street, which is hoping it will provide a new source of growth to turbocharge Gilead’s mature portfolio of pills for HIV and hepatitis C. It’s expected to surpass $4 billion in annual sales by 2031, according to analysts surveyed by Bloomberg. 

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It will compete with Apretude, a prevention shot from ViiV Healthcare, majority-owned by GSK Plc, that’s given every other month.

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While the incidence of HIV has declined since its peak in the 1990s, some 1.3 million people are infected with the virus each year. Some of the highest rates of new cases occur in various countries in Africa. And while daily prevention pills work, they have downsides. People can forget to take them. Others may not want to get them because of the stigma surrounding HIV, or because they worry the pill bottle may inadvertently divulge their high-risk status.

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Gilead has filed for approval in numerous places, including South Africa, Brazil, Australia, Canada, the European Union, and the EU Medicines For All program, which helps speed the review of drugs that will be used in developing countries.

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In one large international trial published last November in men and transgender people, the drug prevented all but two HIV cases among 2,180 people given it, a rate 96% lower than the background incidence level in that population. It was also superior to the company’s old HIV prevention pill Truvada.

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And in June, Gilead said a trial of the shot in women and adolescent girls in Africa prevented 100% of HIV cases, a result the company said was unprecedented.   

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Side effects injection site reactions, which caused 1.2% of people in one study to stop taking it. Gilead already sells the same drug, lenacapavir, as a treatment for people with multidrug-resistant HIV under the brand Sunlenca.

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(Updates with background beginning in second paragraph.)

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