FDA approves new injectable HIV medication amid cuts to federal AIDS programs

Injection administered every six months will protect Ohioans from contracting HIV
(Image by H.L. Comeriato)

The U.S. Food and Drug Administration (FDA) has approved the sale of a new injectable medication that stops the spread of HIV.

Lenacapavir (Yeztugo) is a type of injectable HIV pre-exposure prophylaxis (PrEP), which stops the virus from multiplying inside a person’s body, regardless of how a person comes in contact with it.

Unlike previous versions of the drug – most commonly administered via a daily pill, much like oral contraceptives – lenacapavir is administered via injection just once every six months – which researchers say could both transform the way people living with the virus access care and drastically reduce global HIV transmission rates.

“If you get a shot every six months and then during those six months you cannot contract HIV? That is a huge potential for ending the epidemic and preventing transmission,” said Dr. Brian Bouchard, a primary care physician with Cleveland-based Neighborhood Family Practice (NFP). “Especially in populations that don’t have easy access to healthcare.”

However, the exorbitantly high price of the drug – $14,000 per dose, a total of $28,000 per year – could limit its availability within Ohio’s health care system and delay access for some of the country’s most vulnerable communities.

What is PrEP?

PrEP reduces the risk of contracting HIV by about 99% when taken as prescribed

Pre-exposure prophylaxis (PrEP) is a public health term for a strategy for preventing disease, such as getting a vaccine before you ever get an illness.

“HIV PrEP medication prevents the transmission of HIV so that you can be exposed to the virus but it never gets a foothold in your body,” Bouchard said.You never contract HIV. You never have HIV, even when exposed to the virus.”

“We use the analogy in comparison and birth control. It’s the pill you take every day to prevent you from ever contracting HIV,” he added.

The first oral HIV PrEP medication, Truvada, was approved by the FDA in 2010. Six years later,  the FDA also approved the sale of Descovy, a second type of oral HIV PrEP.

In 2017, a generic version of Truvada was also approved by FDA, and is currently the cheapest and most accessible version of the drug available.

Apretude (cabotegravir) – the first injectable type of HIV PrEP – was approved by the FDA in 2021, and is currently covered by Medicaid in Ohio. However, the drug is administered once every two months compared to lenacapvir’s six months – with an extra injection dose required one month after the first.

“If people can make it to the clinic once every six months, we can do this on a mass scale like with vaccines,” Bouchard said. “We can’t do that with oral PrEP. It’s hard to get to people every month unexpired and then they have to remember to take it.”

“But taking a shot every six months?” he added “We’re almost getting to vaccine territory.” 

Access and efficacy

According to a statement by The Foundation for AIDS Research (amfAR) praising the FDA’s approval of lenacapavir,  just 36% of the 1.2 million Americans who could benefit from HIV PrEP were actually accessing the drug in 2022.

“PrEP is one of the most indispensable tools we have for ending the HIV epidemic,” said amfAR Chief Executive Officer Kevin Robert Frost. “Having the option of a twice-annual shot, rather than relying on a daily pill, will make long-term adherence to PrEP much easier for many.”

“Inconsistent adherence to a daily oral PrEP regimen remains a barrier to its long-term efficacy,” Frost added. “Which is what makes a long-acting injectable option such a promising advancement.”

NFP’s HIV prevention work is funded primarily via the federal government’s Ending the HIV Epidemic (EHE) program. According to a leaked preliminary budget for the 2026 fiscal year, the program narrowly escaped being eliminated entirely.

Initially launched by President Trump during his first presidential term, EHE set a national goal to reduce new HIV infection rates across the country by 75% in five years and 90% in ten years.

In order to do that, hundreds of thousands of people at risk for contracting the virus would need to access pre-exposure prophylaxis treatment before they ever encounter the virus. 🔥


  • To find a doctor that prescribes HIV PrEP near you, click here.
  • To find a Ryan White HIV/AIDS Program medical provider in your area, click here.
  • If you are a young LGBTQ+ person in crisis, please contact the Trevor Project: 866-4-U-Trevor.
  • If you are an transgender adult in need of immediate help, contact the National Trans Lifeline: 877-565-8860

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