FDA Approves Generic HIV Prevention Shot

The U.S. Food and Drug Administration has approved a generic version of lenacapavir, the only HIV prevention shot available that requires only two doses per year. The announcement was made on Monday morning by the manufacturer and partner organizations. This regulatory step is intended to make the drug available more quickly and inexpensively in 120 low- and middle-income countries.

In the target markets, the medication is expected to cost $40 per person annually. This price matches the current cost of daily preventive pills. However, the injection format offers a distinct advantage in adherence. Daily pills require consistent consumption, whereas the shot is administered much less frequently. Two large studies found that the shots nearly eliminated new infections in people at high risk.

Carmen Pérez Casas, the HIV lead for the global health agency Unitaid, noted the difficulty of daily medication. She said that if a patient does not take the daily dose, they are not protected against HIV. With the new generic option, she expressed greater hope for preventing transmission. The World Health Organization reports that 41 million people worldwide lived with HIV and 570,000 died from HIV-related causes last year.

Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, stated that an affordable, high-quality generic medication could help scale prevention to the 20 million people who need it. She added that reaching those numbers could begin to bring an end to the HIV epidemic. The generic version was developed by India-based Dr. Reddy’s Laboratories under an agreement brokered by Unitaid, the Clinton Health Access Initiative, and Wits RHI.

The new generic cannot be sold in the United States because a brand-name version, Yeztugo, made by Gilead Sciences, remains under patent protection. Gilead received FDA approval for Yeztugo last year. The U.S. list price for the brand-name drug is $28,218 a year before insurance. Gilead officials stated this price is similar to other types of pre-exposure prophylaxis.

The FDA approved the generic under a practice designed to ensure the quality of HIV-related drugs provided to other countries by the U.S. government. This approval is considered tentative, which is the standard designation for generics while the originator remains under patent. Until now, Gilead was the sole supplier, and demand in low- and middle-income countries had outstripped supply. Last year, Gilead established royalty-free licensing agreements with six generic manufacturers to enable production in specific regions of sub-Saharan Africa, Asia, and Latin America.

Common side effects of lenacapavir include injection site reactions, headache, and nausea. Patients must be tested for HIV before starting the drug and with each injection. Drug-resistant HIV has been identified when the medication was used by people with an undiagnosed infection. Saiqa Mullick, director of implementation science with Wits RHI, noted that for many low- and middle-income countries, this testing is a rapid test.

Those involved in the effort said the generic should start to become available in some places within weeks. It could take longer in countries that require their own approval processes. Generic versions made by the other licensed manufacturers have yet to be approved by the FDA. Amole said the work is not done, as funding is needed to buy the drug for everyone who needs it. Casa added that scientific advances, political will, and funding are now the key factors in curbing HIV.