Game changer: HIV transmission nearly eliminated by twice-a-year injectable drug — at a $28G annual cost

A twice yearly injection that is highly effective in preventing HIV transmission could dramatically reduce infections and save lives — if the people who would most benefit from the drug can obtain it, Long Island and national health experts say.

The Food and Drug Administration on June 18 approved lenacapavir, sold by Gilead Sciences as Yeztugo, after clinical trials showed the medication nearly eliminated HIV transmission among high-risk people.

But with a $28,218 annual list price and uncertainty about whether or when insurance companies and Medicaid will cover the medication, it’s unclear how many people will take it, experts said.

The injections were 89% more effective in preventing HIV transmission than Gilead’s Truvada, an anti-HIV pill, because subjects were more likely to get the injections than take the pills every day, which is necessary to ensure effectiveness, research showed.

"This is a major advancement going to twice yearly protection, which could significantly improve adherence and reduce new infections," said Devon Zappasodi, director of Bellmore-based PFY, part of the Long Island Crisis Center. "We’re talking about long-acting protection that aligns better with how people live."

Lenacapavir is the newest approved form of pre-exposure prophylaxis, or PrEP, which blocks HIV from spreading through the body. The first, Truvada, was approved in 2012. But studies show that many people not only don’t take the pills every day, but many eventually stop taking them entirely. And relatively few people take a six-times-a-year injection approved in 2021.

Many people forget to take the pills daily or may not want family members to discover them, said Dr. Joseph McGowan, who heads Northwell Health’s Center for AIDS Research and Treatment in Manhasset.

Yeztugo, he said, "removes potential barriers."

Drugs make HIV less dangerous

Patricia Hayes, 69, of Hempstead, said if Yeztugo had been around in the 1980s, when she contracted HIV, it could have prevented the deaths of her many friends who died of AIDS-related causes and stopped her from getting infected.

"I most definitely would have" taken it, said Hayes, adding that getting a shot every six months is easier than taking a pill every day.

Michael Powers, 63, of Sea Cliff, who contracted HIV in 2004, said that "back then, if I had PrEP, maybe things would have worked out differently." 

HIV is far less dangerous than it was during the 1980s and 1990s, mostly because of medications. Even so, HIV was the underlying or a contributing cause of death of nearly 13,000 people in 2022, according to an analysis of federal data by the health policy nonprofit KFF.

After years of drops in new HIV diagnoses, numbers statewide and on Long Island increased between 2020 and 2023, state Health Department data shows. HIV continues to most severely affect Black residents, who statewide are seven times more likely to be diagnosed with HIV than whites, and Latinos, who are nearly five times more likely to contract HIV.

Yet Black and Latino people, and women, take PrEP in much lower numbers than white people compared with their HIV diagnosis rates, according to data from Emory University’s Center for AIDS Research, which found that nearly 600,000 Americans took PrEP in 2024.

Yeztugo, with its twice-a-year regimen, has the potential to increase PrEP use in the most vulnerable communities, Zappasodi said.

"The science behind this is powerful, but without equitable rollout, especially in underserved Black, Latino and LGBTQ communities, it won't meet its full potential," he said.

That includes using "trusted messengers" who are members of the targeted communities to discuss Yeztugo, he said.

Reduced HIV funding

Yet the drug’s release comes amid the Trump administration’s proposal to reduce HIV prevention funding by nearly $800 million. Much of that money has gone to local nonprofits, and without it, "that can certainly affect access to PrEP," said Lindsey Dawson, associate director of KFF’s HIV policy program.

The Affordable Care Act requires that insurers provide free coverage of medications recommended by the U.S. Preventive Services Task Force. The task force in 2023 issued a recommendation for PrEP, and the Supreme Court last month upheld the constitutionality of the ACA's coverage requirement.

Yet, Dawson said, "it’s unclear to me whether insurers are going to presume that [Yeztugo] coverage is required" or whether they will conclude that Yeztugo is not covered under the 2023 recommendation because it is a new medication.

Some insurers could still opt to cover the drug, but, like other high-price medications, it may have high coinsurance costs, limiting the number of people who would receive the injections, she said.

It’s also unclear when the task force would review Yeztugo. Health and Human Services Secretary Robert F. Kennedy Jr. canceled the task force’s July 10 meeting without explanation, and there are concerns he will replace all the task force’s members, as he did previously for a vaccine committee. The Supreme Court ruling gave him the power to fire task force members and overturn recommendations.

Delays of Yeztugo's review could delay insurance coverage, Dawson said. Insurance companies do not have to provide free coverage for a task force-recommended medication until more than a year later — for example, if there were a recommendation this month, insurers would have until July 2026 to cover the drug for its next health plan year, which for many enrollees would begin in 2027, she said.

Medicare has agreed to cover the drug. States decide whether their Medicaid programs cover Yeztugo, Dawson said.

New York currently is reviewing Yeztugo, "which is the standard process for newly approved medications," said health department spokeswoman Cadence Acquaviva.

Gilead said in a statement that it was "working to ensure broad coverage for lenacapavir" and it had programs to assist some people with and without insurance with costs.

As with pill forms of PrEP, a challenge with Yeztugo will be health care providers not talking with patients about the medication, McGowan said. Many people are unaware of PrEP, "and people may not be forthcoming in discussions about what their sexual risk is," so providers need to initiate conversations with all patients about the medication, said McGowan, who sits on a state committee that issued Yeztugo and other PrEP prescribing guidelines.

"If somebody asks for PrEP, we should give it to them, because they may not really be comfortable disclosing their actions," he said.