US medication safety agency approves biannual preventive HIV shot

The US has approved the world’s only twice-a-year shot to prevent HIV, maker Gilead Sciences announced Wednesday.

It's 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 — 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.

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.

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.

“I just got tired of taking pills. It was a preventative, measure and pills were just uncomfortable to remind myself based upon my schedule, based upon what I, what I had going on. And so, this opportunity to take an injection just made more sense for me,” said Haddock, who leads the Normal Anomaly Initiative, a nonprofit serving Black LGBTQ+ communities.

A promising drug, but access and price unclear

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 US and in several other countries hard-hit by HIV.

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.

Gilead didn't immediately announce its price.

The drug only prevents HIV transmission – it doesn’t block other sexually transmitted diseases.

A pandemic far from over

Global efforts at ending the HIV pandemic by 2030 have stalled. There still are more than 30,000 new infections in the US 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.

About half of new infections are in women, who often need protection they can use without a partner's knowledge or consent.