The US has approved the only shot in the world to prevent HIV. This is the first step in a predicted global rollout that can protect millions.
Vaccines to prevent HIV are still needed, but some experts say that the shots made by Gilead Science (a drug called Lenacapavir) could be the next best. It eliminated almost new infections in two groundbreaking studies of people at higher risk than the daily preventative drug they can forget to take.
Greg Millett, director of public policy at AMFAR, the AIDS Research Foundation, said:
Condoms can help prevent HIV infection when used properly, but what is called PREP is becoming increasingly important with the regular use of preventive medications such as daily tablets and another shot given every two months. With six months of protection from Lenacapavir, it is the longest-lasting type. This is an option that may attract people who are wary of more frequent doctor visits and stigma from daily pills.
But the upheaval of US healthcare, including cuts in public health agencies and Medicaid, and the novelty of US foreign aid to combat HIV, have clouded the outlook.
Millett called it “the hole in the system” in the US and worldwide.
Gilead's Drug is already on sale to treat HIV under the brand name Sunlenca. The preventive dose is sold under a different name on Yeztugo. It is given as two injections under the skin of the abdomen, leaving a small “depot” of medicine to slowly absorb into the body. According to Gilead, people must test for HIV negativity before getting two doses a year. It only prevents the spread of HIV and does not block other sexually transmitted diseases. Some researchers who helped test shots advise cold packs to combat the pain in the spray.
Global efforts to end the HIV pandemic by 2030 are stagnating. There are over 30,000 new infectious diseases in the United States each year, with around 1.3 million people worldwide.
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Already, only about 400,000 Americans are already using some form of preparation. Recent studies have shown that HIV infections have decreased in states with high PREP use, while incidence continues to rise elsewhere.
Approximately half of new infectious diseases are women, often requiring protection that can be used without the knowledge or consent of their partner. One rigorous study in South Africa and Uganda compared over 5,300 sexually active young women with teenage girls who were given renacapavir or daily pills twice a year. Although those who received the shot had no HIV infection, approximately 2% of the comparison group caught HIV from their infected sex partners.
The second study found that two shots per year were roughly equally effective in gay men and those who make up the gender of the US, as well as in several other countries highlighted by HIV.
Houston's Ian Huddock has been trying to stop preparing since 2015, but he jumped at the chance to take part in the Lenacapaville Study, continuing his shots twice as part of his follow-up to the study.
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“We don't have to carry a pill bottle around, so we forget we're in preparation,” said Haddock, who leads the usual extraordinary initiative, a nonprofit that serves the black LGBTQ+ community.
“Men, women, gay, straight — it really only expands the opportunities for prevention,” he added. Just remembering clinic visits every six months and “it's a powerful tool and not always checking that you're taking a pill every day, like a condom.”
At a reasonable price, the shot may “do nothing change”
Gilead said the pre-insurance US list price is $28,218 per year, which is called the same as other prep options. The company not only anticipates insurance coverage, but also has several financial aid programs.
Most private insurers are considering cases where the Supreme Court could overturn that requirement, but are supposed to cover preparation options without a joint payment. Congress is also considering massive Medicaid cuts. And while community health centers are still an option, the Trump administration has largely dismantled HIV prevention work at the Centers for Disease Control and Prevention, which usually delivers a message to vulnerable groups qualifying for Shot, said Carl Schmid of the nonprofit HIV+Hepatitis Policy Institute.
Schmid is worried that the shots will not meet that possibility as they “essentially pull the rug out of the HIV prevention and testing and outreach programs.”
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Gilead is also pending applications for two shots a year in other countries. Last fall, the company signed contracts with six generic drugmakers, creating low-cost versions of shots for 120 poor countries, primarily in Africa, Southeast Asia and the Caribbean. Gilead plans to create enough shots to supply two million people without profits until generics are available, said Dr. Jared Baeten, senior vice president of the company.
Winnie Byanyima, executive director of UNAIDS, said in a statement that the prices are still too high. If it was affordable, she said, “Nothing will change.”
HIV experts are also concerned about the arrangements Gilead has made to reduce the costs of some countries, such as parts of Latin America, to exclude some middle-income countries.
“Everyone in the country where HIV risks need to access PREP,” said Dr. Gordon Crohoot of Houston. “We need to make it easier to access such a highly effective preparation.”
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