US Approves Twice-A-Year Shot to Prevent HIV

WASHINGTON — The U.S. has approved the world’s only twice-a-year shot to prevent HIV, the first step in an anticipated global rollout that could protect millions – although it’s unclear how many in the U.S. and abroad will get access to the powerful new option.

While a vaccine to prevent HIV still is needed, some experts say the shot made by Gilead Sciences — a drug called lenacapavir — could be the next best thing. It nearly eliminated new infections in two groundbreaking studies of people at high risk, better than daily preventive pills they can forget to take.

“This really has the possibility of ending HIV transmission,” said Greg Millett, public policy director at amfAR, The Foundation for AIDS Research.

How Lenacapavir Works

Condoms help guard against HIV infection if used properly but what’s called PrEP — regularly using preventive medicines such as the daily pills or a different shot given every two months — is increasingly important. Lenacapavir’s six-month protection makes it the longest-lasting type, an option that could attract people wary of more frequent doctor visits or stigma from daily pills.

Gilead’s drug already is sold to treat HIV under the brand name Sunlenca. The prevention dose will be sold under a different name, Yeztugo. It’s given as two injections under the skin of the abdomen, leaving a small “depot” of medication to slowly absorb into the body. People must test negative for HIV before getting their twice-a-year dose, Gilead warned. It only prevents HIV transmission — it doesn’t block other sexually transmitted diseases. Some researchers who helped test the shot advise cold packs to counter injection-site pain.

Global Efforts to End HIV Pandemic

Global efforts at ending the HIV pandemic by 2030 have stalled. There still are more than 30,000 new infections in the U.S. each year and about 1.3 million worldwide.

Only about 400,000 Americans already use some form of PrEP, a fraction of those estimated to benefit. A recent study found states with high use of PrEP saw a decrease in HIV infections, while rates continued rising elsewhere.

Studies on Lenacapavir

About half of new infections are in women, who often need protection they can use without a partner’s knowledge or consent. One rigorous study in South Africa and Uganda compared more than 5,300 sexually active young women and teen girls given twice-yearly lenacapavir or the daily pills. There were no HIV infections in those receiving the shot while about 2% in the comparison group caught HIV from infected sex partners.

A second study found the twice-yearly shot nearly as effective in gay men and gender-nonconforming people in the U.S. and in several other countries hard-hit by HIV.

Real-Life Experience with Lenacapavir

Ian Haddock of Houston had tried PrEP off and on since 2015 but he jumped at the chance to participate in the lenacapavir study and continues with the twice-yearly shots as part of the research follow-up.

“Now I forget that I’m on PrEP because I don’t have to carry around a pill bottle,” said Haddock, who leads the Normal Anomaly Initiative, a nonprofit serving Black LGBTQ+ communities.

“Men, women, gay, straight – it really just kinds of expands the opportunity for prevention,” he added. Just remembering a clinic visit every six months “is a powerful tool versus constantly having to talk about, like, condoms, constantly making sure you’re taking your pill every day.”

Cost and Accessibility

Gilead said the U.S. list price, meaning before insurance, is $28,218 a year, which it called similar to some other PrEP options. The company said it anticipated insurance coverage but also has some financial assistance programs.

Most private insurers are supposed to cover PrEP options without a co-pay although the Supreme Court is considering a case that could overturn that requirement. Congress also is considering huge cuts to Medicaid. And while community health centers still are an option, the Trump administration has largely dismantled HIV prevention work at the Centers for Disease Control and Prevention that would normally get the message to vulnerable populations who’d qualify for the shot, said Carl Schmid of the nonprofit HIV+Hepatitis Policy Institute.

Global Availability

Gilead also has applications pending for the twice-yearly shot in other countries. Last fall, the company signed agreements with six generic drug makers to produce low-cost versions of the shot for 120 poor countries mostly in Africa, Southeast Asia and the Caribbean. Gilead plans to make enough shots to supply 2 million people in those countries, at no profit, until the generics are available, said company senior vice president Dr. Jared Baeten.

Winnie Byanyima, executive director of UNAIDS, said in a statement the price is still too high. If it’s unaffordable, she said, “it will change nothing.”

Conclusion

The approval of the twice-a-year shot to prevent HIV is a significant step forward in the fight against the disease. However, the cost and accessibility of the shot remain a concern, and it is unclear how many people will have access to it. Despite these challenges, the shot has the potential to make a significant impact in reducing the number of new HIV infections worldwide.

Frequently Asked Questions

Q: What is lenacapavir and how does it work?

A: Lenacapavir is a twice-a-year shot that prevents HIV transmission. It is given as two injections under the skin of the abdomen, leaving a small “depot” of medication to slowly absorb into the body.

Q: How effective is lenacapavir in preventing HIV transmission?

A: Lenacapavir has been shown to be highly effective in preventing HIV transmission in two groundbreaking studies. In one study, there were no HIV infections in those receiving the shot, while about 2% in the comparison group caught HIV from infected sex partners.

Q: Is lenacapavir available to everyone?

A: The cost and accessibility of lenacapavir remain a concern, and it is unclear how many people will have access to it. The U.S. list price is $28,218 a year, and while Gilead has some financial assistance programs, the shot may not be affordable for everyone.

Q: Can lenacapavir be used to treat HIV?

A: No, lenacapavir is only approved for the prevention of HIV transmission. It is not a treatment for HIV.