Generic HIV drug marks turning point in the fight against epidemic

Scientists and health experts in Kenya and globally have welcomed the introduction of a generic long-acting HIV injectable, citing its affordability and potential to expand access in low-income countries.

The injectable, Lenacapavir, is expected to play a key role in efforts to eliminate HIV, following UNAIDS’ call for countries to end the epidemic amid funding challenges.

The drug will be made available in at least 120 low-income countries.

The announcement was made through a collaboration between the Gates Foundation, the Clinton Health Access Initiative (Chai), Wits RHI in South Africa, and other partners.

The injectable, administered twice annually, could be rolled out as early as the end of this year, with a lower-cost version expected in 2027.

Costing of the drug is set at approximately $40 (Sh5,180), per person annually. But during an announcement made on Wednesday, the entities promised to slash the price to $25 (Sh 3,237) per person annually.

Julius Oyugi, Director of Research at the University of Nairobi’s Institute of Tropical and Infectious Diseases, said the original injectable could not be affordable in developing countries, and even in developed countries, they were unaffordable.

“Generics HIV injectables are much cheaper and in terms of accessibility to the people who need long term injectable for HIV. This reduces the cost and has many people access it,” said Prof Oyugi.

The drug is the first long-acting injectable form of pre-exposure prophylaxis (PrEP), offering an alternative to the daily oral pills currently used for HIV prevention.

It is administered after every six months, a period where individuals are protected from acquiring HIV.

“It will be a game changer, and we expect it to go lower than what is being proposed,” he said.

The agreements were announced during the United Nations General Assembly in New York.

The Unitad, Chai, and Wits RHI are providing financial, technical, and regulatory support to Indian generic manufacturer Dr Reddy’s Laboratories, enabling the annual cost of injections to come to just $40.

 An initial oral dose required alongside the first injections will cost no more than $17 (Sh 2,201) under the agreement.

The Gates Foundation will support Indian generic manufacturer Hetero Drugs with upfront funding and volume guarantees to ensure a cost of around $40 per patient per year following the short pre-treatment oral regimen.

Lenacapavir adds to the suite of HIV prevention options currently available including condoms, vaginal rings and daily prevention pills.

In research published in The Lancet HIV, experts estimated if purchased at scale, the cost of generic lenacapavir could range from $35 (Sh4,533) to $46 (5,957) per person-year.

Falling to $25 with high demand, making the medicine affordable even for low-income countries.

Oyugi said there is need for the global community to come together to purchase the drug for people who need it, at a time donor, more so USAID that used to support HIV commodities pulled out.

“We need global campaign to approach pharmaceutical companies to try lower the cost of the drug. I believe this is going to happen through Wold Health Organisation, Africa CDC,”he said.

In terms of efficacy, he said the generic drug is as good as the original one.

He dismissed claims that generics are not strong enough, saying the chemical composition is same.

“A generic name is used once the patent held by the original company expires, allowing other manufacturers to produce the same medication under a different, non-branded name. This is where the difference comes in but the chemical composition still remains the same. Efficacy is same as original one.”

Findings of trials of the drug published in the New England Journal of Medicine found that lenacapavir was between 96 and 100 per cent effective in preventing new HIV infections.

He added, “The main obstacle to HIV prevention in Kenya and other countries is adherence to drugs; daily pill-taking is difficult, and inconsistent use can result in drug resistance,” he said.

Oyugi pointed out that securing funds to provide drugs to high-risk groups, like men who have sex with men, is crucial because it will reduce HIV spread

UNAIDS also welcomed the announcement of two new agreements to advance progress in stopping new HIV infections. UNAIDS estimates show that 1.3 million people were infected with HIV in 2024 far higher than the target of 370,000 by 2025.

The UN agency estimates that if 20 million people in the highest need, including men who have sex with men, sex workers, people who inject drugs and young women and adolescent girls in sub-Saharan Africa have to access Lenacapavir, this could dramatically reduce new infections and advance progress in ending Aids by 2030. 

“This is a watershed moment. A cost of $40 per person per year is a leap forward that will help to unlock the potential of long-acting HIV medicines,” said Winnie Byanyima, UNAIDS Executive Director.