Approval of India-made HIV-prevention shot raises hopes in poorer nations

The US Food and Drug Administration (FDA) has approved an India-made generic version of the world’s only twice-a-year injection to prevent HIV, marking a major step towards making the drug available at an affordable price in 120 low- and middle-income countries.

The announcement was made on Monday morning by the manufacturer and organisations that helped accelerate the development of the medication, called lenacapavir.

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.

The drug is expected to cost USD 40 a year per person in the countries where it will be available, the same price as daily preventive pills currently available. However, the shots are much more convenient because they are needed far less frequently and nearly eliminated new infections in two groundbreaking studies of people at high risk.

People do not always take their daily medication, “and if you do not take it, you cannot get protected against HIV,” said Carmen Perez Casas, HIV lead for 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, as well as deaths. According to the WHO, 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,” said Carolyn Amole, who leads the HIV programme for the Clinton Health Access Initiative.

PrEP, or pre-exposure prophylaxis, is prescription medication taken by people at risk of HIV before being exposed to the virus.

“And if we scale to those levels,” she added, “we can actually begin to bring an end to the HIV epidemic.”

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

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 US government. Approval by the US FDA can speed up regulatory approval in many other countries. The approval is considered “tentative”, the FDA’s standard designation for generics while the original drug 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 licences cover specific 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.”

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

“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 is expected to start becoming available in some places within weeks, organisations involved in the effort said. However, it could take longer in countries that require the drug to undergo their own approval processes before it can be administered. Generic versions made by the other manufacturers have yet to receive FDA approval.

“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.”

Perez Casas said she was optimistic that scientific advances, along with political will and funding, could help the world curb HIV.

“Now,” she said, “we have the tools.”