The US Food and Drug Administration (FDA) on June 18 approved a new preventive injection that protects against HIV — it only needs to be given twice a year. It has been shown to be nearly 100 percent effective in trials. It is one of the most anticipated advances in HIV prevention.
The New York Times writes about this.
The drug, called “Lenacapavir”, was developed by Gilead Sciences and will be sold under the name Yeztugo. It has been in development for nearly 20 years and has exceeded expectations in testing: studies have shown that no less than 99.9% of participants remained HIV-negative when given the drug twice a year.
It is only the second long-term HIV prevention drug in the world. The first was “Cabotegravir” (brand name “Apretude”), which requires an injection every two months. It is manufactured by ViiV Healthcare, a subsidiary of British pharmaceutical giant GSK (GlaxoSmithKline). Apretude is currently used by nearly 21 000 Americans, while about 500 000 use daily HIV prevention pills.
Many experts believe that the convenience of a new injection that only needs to be given twice a year could change the course of HIV spread.
“We are on the verge of having the best prevention option in 44 years of HIV,” says Mitchell Warren, executive director of the international organization AVAC.
But the drug was approved amid a sharp reduction in funding for global health programs that were supposed to purchase and distribute it in low-income countries, and it is now unclear how it will be distributed there. The reduced funding could lead many governments to prioritize treating those already infected over prevention.
Today, “Lenacapavir” is already used to treat HIV in people who do not respond to other drugs. The price is about $42 thousand per year. But for prevention, it will be sold for $28 218 per year. For comparison: generic pills cost only $1 per dose, and Apretude — $24 thousand per year.
Gilead says most people in the US wonʼt pay full price, thanks to insurance or patient assistance programs. But advocates warn that insurance companies could impose restrictions and make it harder to access the drug.
There is a risk that legislative changes in the US will also limit access to “Lenacapavir” — in particular, due to cuts in funding for the US governmentʼs Medicaid program. Namely, in states where Medicaid has been expanded, 33% more people use prophylaxis than in others.
In the United States, more than 39 000 people were infected with HIV in 2023. According to Gilead CEO Daniel OʼDay, treating one such person over a lifetime costs $1.1 million.
The situation is even more complicated in the world. In 2023, 1.3 million people will be infected with HIV. Gilead has promised to allow six companies to produce and sell “Lenacapavir” at affordable prices in 120 poor countries. But that will take years. In the meantime, the company will provide the drug to 2 million people at a price without a profit.
But the deal does not apply to middle-income countries, such as Brazil, which together with other middle-income countries accounts for 25% of new HIV cases. Gilead says it has filed for approval in Brazil and is in talks with other countries about pricing.
The drug will also be available to several thousand people in the US, Brazil and South Africa who are participating in studies.
But advocates say it still leaves millions without access, leaving them to rely on daily pills that research shows are not always effective or for everyone.
In addition, the US plans to cut funding for programs such as PEPFAR (the US Global Program on HIV/AIDS Relief) and the Global Fund to Fight HIV, Tuberculosis and Malaria. They are the ones who should become the largest buyers of the new drug.
In January, the Trump administration halted payments from PEPFAR, which provided treatment in many countries, and while treatment was resumed through exemptions, funding for prevention was never restored (except in cases where it is necessary to prevent HIV transmission from a pregnant mother to her child).
He adds that in the United States itself, the current administration is harming HIV prevention — blocking funding, disrupting research, and limiting programs.
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