A revolutionary new preventative medicine that protects against the HIV virus has just been approved by the U.S. Food and Drug Administration. However, some experts are concerned about the high price for the drug.
“We’re very excited,” Dr. Monica Gandhi, associate division chief of the HIV, Infectious Diseases, and Global Medicine Division at UCSF and San Francisco General Hospital, told KCBS Radio. “The caveat is going to be the price, but we’re very excited about the release of this.”
She said that the medication – lenacapavir, marketed as Yeztugo by its developer, pharmaceutical company Gilead – is expected to cost $28,000 annually to administer. The injectable HIV-1 capsid (viral protein shell) inhibitor needs to be injected once every six months. That’s far less than existing preventative HIV medications that need to be taken daily.
PrEP medication, another preventative medication that protects against HIV, was also developed by Gilead and was approved in the U.S. in 2012.
“However, data from the Centers for Disease Control and Prevention (CDC) show that, in 2022 (the most recent year with available data), only about 1 in 3 (36%) people in the U.S. who met the CDC’s eligibility criteria for PrEP were prescribed a form of PrEP,” according to the company.
Now, the company hopes that its new medication will increase the number of in-need people getting protection against the virus.
“Data show that ≥99.9% of participants who received Yeztugo in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative,” said Gilead in a press release. Ghandi explained that the drug works by preventing HIV, which can lead to AIDS, from “setting up shop” in the body.
HIV is a virus spread through sexual intercourse or blood that attacks the immune system. There is no cure for it, but people can live with HIV if they receive treatment. If it develops into AIDS, the body has a difficult time fighting off infections. At that point, patients are expected to have around three years to live.
While lenacapavir is a breakthrough drug that could help the estimated 2.5 million people in the U.S. who need HIV prevention, as well as anyone else who is sexually active, Ghandi is concerned that its high price might mean its left out of Medicaid formularies. She said that other HIV medications have been included due to their reasonable prices.
“It’s very novel thing to have to give an HIV preventative agent just once every six months as opposed to every day,” Ghandi said. “And I think it’s very exciting to have it. It also, in the trials, which were called Purpose I and II, and they were studied in women and men, respectively, this really works, meaning this HIV prevention medication really blocks HIV from getting in.”
Even with the high price, she said that people who might be at risk of contracting HIV should ask their doctor about the medication.