India-Made HIV Prevention Shot Approved

Introduction of Generic HIV Prevention Shot

The US Food and Drug Administration has approved an India-made generic version of the world's only twice-a-year shot to prevent HIV, a significant step towards making the drug available inexpensively and more quickly in 120 low- and middle-income countries. The announcement was made by the manufacturer and organisations that helped to speed up 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.

Background and Timeline

The development of lenacapavir is a result of a longstanding collaboration between various organisations, including Unitaid, the Clinton Health Access Initiative, and Wits RHI. The agreement to develop the generic version of the medication was brokered in 2020, with the goal of making the drug available at an affordable price in low- and middle-income countries.

The US FDA approval of the generic medication is a significant milestone in the fight against HIV. According to Carmen Perez Casas, HIV lead for the grant-making organisation Unitaid, the approval of lenacapavir is a major step forward in making HIV prevention more accessible and affordable.

Benefits of the Generic Medication

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.

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 Perez Casas, HIV lead for the grant-making organisation Unitaid, a global health agency. With lenacapavir, we are much more hopeful.

Expert Perspective

According to Carolyn Amole, who leads the HIV programme for the Clinton Health Access Initiative, the approval of lenacapavir is a game-changer in the fight against HIV. 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.

Impact on HIV and AIDS

Ultimately, advocates said, the medication should help drive down cases of HIV and AIDS -- and 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, prescription medicine taken by people at risk of HIV before being exposed to the virus, said Carolyn Amole, who leads the HIV programme for the Clinton Health Access Initiative, a global health organisation.

• The generic medication is expected to cost $40 a year per person.
• The shots are much more convenient than the pills because they're needed much less frequently.
• The medication nearly eliminated new infections in two groundbreaking studies of people at high risk.

Availability of the Generic Medication

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.

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.

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Implications for Readers in India

The approval of the generic medication is significant for readers in India, as it will make the drug more accessible and affordable. According to Saiqa Mullick, director of implementation science with Wits RHI, the generic medication will be available in India at an affordable price, making it a viable option for people at high risk of HIV.

Next Steps

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.

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.

Casa said she's optimistic that scientific advances — along with political will and funding — can help the world curb HIV. Now, we have the tools.

• 41 million people worldwide were living with HIV last year.
• 570,000 people died from HIV-related causes last year.
• 20 million people around the world need PrEP.

What to Watch Next

The approval of the generic medication is just the first step in making it available to people at high risk of HIV. The next steps will involve ensuring that the drug is accessible and affordable, and that people are aware of its benefits and how to access it.

Readers can expect to see more updates on the availability and accessibility of the generic medication in the coming weeks and months. In the meantime, it's essential to continue raising awareness about the importance of HIV prevention and the need for affordable and accessible treatment options.