Here’s What Everyone Needs to Know About the New HIV Prevention Shot

A twice-a-year shot to prevent HIV has the potential to greatly reduce the spread of the virus in the United States and the rest of the world, but concerns about cost and accessibility remain , health care experts said.

Yeztugo (generic name lenacapavir), made by Gilead Sciences, received approval from the Food and Drug Administration on Wednesday.

Yeztugo costs $14,109 per injection or $28,218 a year, before insurance .

“Anyone who is likely to be exposed to HIV through sexual contact, who is interested in subcutaneously injected medications and who does not have HIV” can take Yeztugo, said Raphael J. Landovitz , director of the UCLA Center for Clinical AIDS Research and Education.

But Yeztugo would be mostly for at-risk people who might find it challenging to take a daily pill for prevention, such as Descovy or Truvada, said Eileen Scully , an associate professor of medicine who researches HIV at Johns Hopkins School of Medicine.

“The more people who know about it, the better, because this is a really empowering step for people to take” in addition to already available treatments, she said.

The facts

• Yeztugo is a pre-exposure prophylaxis (PrEP) that aims to prevent new sexually transmitted HIV infections in adults and adolescents weighing at least 35 kg (77 pounds). The injection is administered twice a year in clinics.
• The FDA approval was supported by data from two trials. In a randomized trial , none of the more than 5,000 young women and girls in South Africa and Uganda who received Yeztugo contracted HIV.
• In another randomized trial , there were two HIV infections among the group of men and gender-diverse people who received Yeztugo when compared with nine HIV infections in the group that took Truvada, a once-daily oral HIV treatment and prevention pill.
• Only HIV-negative individuals should get Yeztugo and they must be tested before every injection, Gilead said in a news release. Resistance to Yeztugo may develop if an individual is infected with the virus before or when getting the drug, or after they discontinue it.
• The most common side effects are reactions at the injection site, including pain, swelling or redness, Scully said.

Background

In 2022, lenacapavir, under the brand name Sunlenca, was approved by the FDA as a treatment, given in addition to existing therapies, for multidrug resistant HIV infections .

Gilead sought FDA approval for lenacapavir, under the brand name Yeztugo, as an HIV prevention drug. It was granted Breakthrough Therapy designation in October, which helps “expedite the development and review of drugs to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s),” the FDA says.

The journal Science named lenacapavir its “ 2024 Breakthrough of the Year ” based on the results of the two clinical trials and “a basic research advance: a new understanding of the structure and function of HIV’s capsid protein, which lenacapavir targets.”

Lenacapavir is a “groundbreaking” drug because it simplifies what is required for a person to protect themselves against HIV, and people will probably have a higher adherence to it, said Leandro A. Mena , a professor at the Emory University School of Medicine.

Lenacapavir stops the HIV from forming a protective coating called the capsid, ensuring “baby viral particles can’t be made,” said Monica Gandhi , the medical director of the HIV Clinic at Ward 86 and a professor of medicine at the University of California at San Francisco.

“It blocks the virus from, essentially, setting up shop in the body,” Gandhi said. “It essentially stops viral replication.”

At the first injection of lenacapavir, patients have to take two oral doses of the drug — one at the clinic and another the day after — to ensure the drug levels are high enough to be protective “within the first four days,” Gandhi said. Subsequent doses are given every six months.

In the clinical trials, patients could be up to 14 days late to getting a dose, she said.

Important context

Yeztugo could further decrease the spread of HIV in the U.S., the experts said, though some groups have benefited less from PrEPs than others.

The estimated number of new HIV infections in the U.S. in 2022 was 31,800 , a 12 percent decrease from 2018 (36,200), according to the Centers for Disease Control and Prevention. The agency said increases in PrEP “prescriptions, viral suppression and HIV testing likely contributed to the decline.”

The agency suggests health care providers prescribe PrEP to “anyone who asks for it, including sexually active people who do not report HIV risk factors.” The agency also recommends that PrEP be part of a “comprehensive HIV prevention plan that includes discussing how to take PrEP as prescribed, proper condom use, screening for other sexually transmitted infections (STIs), and other risk-reduction methods.”

PrEPs have been available for more than a decade, and can be administered as daily pills or injections — cabotegravir (Apretude) is taken every other month . But the CDC found that in 2022, only “ one-third of people in the U.S. who could benefit from PrEP had been prescribed it.” And fewer Black people (13 percent) and “Hispanic/Latino people” (24 percent) who could benefit from PrEPs were prescribed it than White people (94 percent).

Barriers, including cost, could reduce its effect

Long-acting forms of PrEP are easier for people to take than daily pills, which can be forgotten, some experts said.

Every PrEP option available is “almost 100 percent effective if used correctly,” Gandhi said, but “it’s hard to take that pill every day. And it’s hard to stay on that pill for years and years.”

She said her clinic has studied how people dealing with housing instability and substance use have higher rates of retention when they take a long-acting PrEP.

Landovitz called Yeztugo a “new powerful tool in the HIV prevention toolbox.” He added that, “in many settings, fewer annual contacts with the health care system is easier, more acceptable and a lower burden to both providers and patients.”

However, the cost can be prohibitive for many people, especially when insurance does not cover it.

Most private insurance and Medicaid programs are required to cover PrEP services without co-pays or deductibles, or other cost sharing, according to federal guidelines, the CDC says.

The generic version of Truvada, a daily pill, can cost $30 a month. Yeztugo costs $14,109 per dose — around the same cost as the bimonthly PrEP injection, cabotegravir (Apretude).

Gandhi said “I’m very worried about health insurance plans saying that the price point is too expensive.”

Beyond cost, other barriers to PrEPs among at-risk heterosexuals “include limited PrEP awareness, medical mistrust, HIV stigma, and low perceived personal risk. Structural barriers impeding PrEP use include poverty impeding access to health insurance and care, limiting mobility and health literacy,” a 2019 review said.

An HIV vaccine could theoretically provide longer protection. HIV vaccine development is still ongoing, though there have been questions about funding cuts for that line of research, Scully said.

“My personal feeling is that preventive therapeutics are critical, but vaccines are also going to be necessary for us to really end the HIV epidemic, which I think is the goal of everyone who works in this field,” she said.