US regulators approve sale of generic version of HIV prevention drug in low-income countries

The United States Food and Drug Administration has approved a generic version of the only shot in the world twice a year to prevent HIV – a big step towards making the drug available more quickly and cheaply in 120 low- and middle-income countries.

The announcement was made Monday morning by the manufacturer and organizations that helped accelerate development of the drug, called lenacapavir.

The drug is expected to cost $40 per year per person in countries where it will be available, the same price as the daily preventative pills currently available. But the shots are much more convenient than pills because they are used much less frequently and they nearly eliminated new infections in two groundbreaking studies of people. high risk.

People don’t always take their daily dose of medication, “and if you don’t take it, you can’t protect yourself against HIV,” said Carmen Pérez Casas, HIV manager at grantmaking organization Unitaid, a global health agency. “With lenacapavir, we have a lot more hope.”

Ultimately, advocates say, the drug should help reduce HIV and AIDS cases — and deaths. According to the World Health Organization, 41 million people worldwide were living with HIV and 570,000 died from HIV-related causes last year.

With an affordable, high-quality generic drug now available, “we could help expand this program to the 20 million people around the world who need PrEP,” a prescription drug taken by people at risk of HIV before being exposed to the virus, said Carolyn Amole, who directs the HIV program for the Clinton Health Access Initiative, a global health organization.

“And if we reach these levels,” she added, “we can actually begin to end the HIV epidemic.”

Generic lenacapavir cannot be sold in the United States because a brand-name version, Yeztugo, made by Gilead Sciences and approved last year, is still protected by patent. The US list price for this version, that is, the cost before insurance, is $28,218 per year. Gilead officials say this is similar to some other types of PrEP, which stands for pre-exposure prophylaxis.

The new generic was approved by the FDA as part of a long-standing practice to ensure the quality of HIV-related drugs supplied to other countries by the U.S. government. Approval of a drug by the US FDA can expedite regulatory approval in many other countries. The approval is considered “provisional,” the FDA’s standard designation for generics, while the originator remains under patent.

Until now, Gilead was the sole supplier of lenacapavir. Demand has outstripped supply in low- and middle-income countries, although Gilead has entered into royalty-free licensing deals with six generic makers to enable increased production. These voluntary licenses cover a specific set of countries in sub-Saharan Africa, Asia and Latin America.

“We share the sense of urgency regarding expanding access to lenacapavir for HIV prevention,” a Gilead spokesperson said in a statement. “We believe we have provided the fastest and most sustainable path to expanding access to communities most affected by HIV. »

The generic was developed by Dr. Reddy’s Laboratories, based in India, under an agreement negotiated by Unitaid, the Clinton Health Access Initiative and Wits RHI, a health research institute in Africa. The partners sought to accelerate development and make the drug available at an affordable price.

Common side effects of lenacapavir include injection site reactions, headache, and nausea. People should also be tested for HIV before starting the medicine and with each injection; Drug-resistant HIV has been identified when used by people with undiagnosed HIV infection.

“For any type of PrEP… you need to be tested for HIV in advance,” said Saiqa Mullick, director of implementation science at Wits RHI. “For many low- and middle-income countries, this is a rapid test. »

Generic lenacapavir should start becoming available in some places within a few weeks, those involved in the effort said, although it could take a little longer in countries that require the drug to go through their own approval processes before people can start taking it. Generic versions made by other manufacturers have not yet been approved by the FDA.

“The work is not done. Now we need funds to buy it for everyone who needs it, and then we have to work hard to get it to the millions of people who need it and want it,” Amole said. “But it’s an important step.”

Casas said she is optimistic that scientific advances, along with political will and funding, can help the world fight HIV.

“Now,” she said, “we have the tools. »

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Associated Press writer Gerald Imray in Cape Town, South Africa, contributed to this story.

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