The U.S. Food and Drug Administration has approved a generic version of the world's only twice-a-year shot to prevent HIV — a big step toward making the drug available inexpensively and more quickly in 120 low- and middle-income countries.
The announcement was made on Monday morning by the manufacturer and organizations that helped to speed up development of the medication, called lenacapavir.
The drug is expected to cost $40 a year per person in the countries where it will be available, the same price as daily preventive pills available now. But the shots are much more convenient than the pills because they're needed much less frequently and they nearly eliminated new infections in two groundbreaking studies of people at high risk.
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People don't always take their daily dose of medication, "and if you do not take it, you cannot get protected against HIV," said Carmen Pérez Casas, HIV lead for the grant-making organization Unitaid, a global health agency. "With lenacapavir, we are much more hopeful."
Ultimately, advocates said, the medication should help drive down cases of HIV and AIDS — 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 medication now available, "we could help to scale this to the 20 million people around the world who need PrEP," prescription medicine taken by people at risk of HIV before being exposed to the virus, said Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, a global health organization.
"And if we scale to those levels," she added, "we can actually begin to bring an end to the HIV epidemic."
Generic lenacapavir can't be sold in the U.S. because a brand-name version, Yeztugo, made by Gilead Sciences and approved last year, is still protected by a patent. The U.S. list price for that version, meaning the cost before insurance, is $28,218 a year. Gilead officials say that's similar to some other types of PrEP, which stands for pre-exposure prophylaxis.
The new generic was approved by the FDA under a longstanding practice designed to ensure the quality of HIV-related drugs provided to other countries by the U.S. government. Approval of a drug by the U.S. FDA can speed regulatory approval in many other countries. The approval is considered "tentative," the FDA's standard designation for generics while the originator remains under patent.
Until now, Gilead has been the sole supplier of lenacapavir, and demand has outstripped supply in low- and middle-income countries. Last year, Gilead established royalty-free licensing agreements with six generic manufacturers to enable production. Those voluntary licenses cover a specific set of countries in sub-Saharan Africa, Asia and Latin America.
"We share the sense of urgency around expanding access to lenacapavir for HIV prevention," a Gilead spokesperson said in a statement. "We believe we have enabled the fastest and most sustainable path to expanding access for communities most affected by HIV."
The generic was developed by India-based Dr. Reddy's Laboratories under an agreement brokered 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 with lenacapavir include injection site reactions, headache and nausea. People also must be tested for HIV prior to starting the drug and with each injection; drug-resistant HIV has been identified when used by people with an undiagnosed HIV infection.
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"For any kind of PrEP … you need to have HIV testing in advance," said Saiqa Mullick, director of implementation science with Wits RHI. "For many of the low- and middle-income countries, that is a rapid test."
Generic lenacapavir should start to become available in some places within weeks, those helping with the effort said, although it could take a bit longer in countries that require the drug to go through their own approval processes before people can start taking it. Generic versions made by the other manufacturers have yet to be approved by FDA.
"The work is not done. Now, we need the funding to actually buy it for everyone who needs it and then we need to do the hard work of getting it to the millions of people who need it and want it," Amole said. "But this is a great milestone."
Casas said she's optimistic that scientific advances — along with political will and funding — can help the world curb HIV.
"Now," she said, "we have the tools."
