Today, the World Health Organization released new guidelines that add twice yearly lenacapavir as an additional pre-exposure prophylaxis option and support simple rapid diagnostic test pathways as another HIV prevention tool.

These updates aim to keep progress in HIV prevention and treatment from stalling and to make care simpler in clinics and communities.

Lenacapavir is a long acting shot given twice a year that blocks HIV at a very early stage by targeting the virus’s protective shell, called the capsid.

It joins daily pills, an injectable given every two months, and a vaginal ring, so people and programs can choose what fits.

Why this shot matters

By the end of 2024, an estimated 40.8 million people were living with HIV and about 1.3 million people acquired HIV that year, according to a WHO update. 

“We have the tools and the knowledge to end AIDS as a public health problem,” said Dr. Meg Doherty, Director of WHO’s Department of Global HIV, Hepatitis and STI Programmes.

Fewer clinic visits can mean better adherence and more privacy for people who cannot manage daily pills or frequent pickups. Two visits a year can also help programs plan outreach and track follow up without overloading staff.

Importantly, this is an extra choice, not a replacement for other methods. Daily antiretroviral therapy (ART) remains the standard for people living with HIV, and oral and injectable PrEP still matter for prevention.

HIV prevention with lenacapavir

The medicine is a capsid inhibitor, a class that binds to the protein shell that surrounds HIV and interferes with steps the virus needs to copy itself.

By blocking multiple steps, the drug keeps the virus from establishing infection after exposure.

In a large trial of cisgender women in South Africa and Uganda, no participants who received twice yearly lenacapavir acquired HIV during the analysis period.

The lenacapavir group showed a lower incidence of infection than background rates and daily oral PrEP comparators.

Two clinic visits per year can fit school, work, or caregiving schedules that make frequent appointments hard. Sites can add safety checks, counseling, and STI screening to those visits so the prevention package stays comprehensive.

How testing will work

The WHO guidance supports using simple rapid diagnostic test checks to start, continue, or pause long acting PrEP.

This removes complex lab steps that have slowed access, and it enables delivery through pharmacies, clinics, and telehealth.

Home tests can play a role at key decision points, provided programs confirm results and link people to follow up.

Clear instructions, quality kits, and documented training will keep mistakes rare and allow same day starts in many settings.

Programs will still need periodic clinic testing to confirm HIV negative status before each injection. They will also need systems to monitor missed visits and manage switches between options without gaps.

Access and price pressures

“We have seen services vanish overnight,” said Winnie Byanyima, Executive Director of UNAIDS. The United States Food and Drug Administration has approved lenacapavir for HIV prevention, and the company reported a U.S. list price of 28,218 dollars per person per year.

That figure mirrors existing prevention medicines in the U.S., yet most countries will need prices closer to cost and reliable supply.

Lower prices, not for profit supply agreements, and faster registration can help scale access beyond pilot sites. Community based delivery will also matter so people who face stigma or criminalization can reach care safely.

Next steps for HIV prevention

Countries will need to update national guidelines, train providers, and set up procurement and cold chain plans that match twice yearly delivery.

Pharmacovigilance, data systems, and community feedback loops should be in place before scale up.

Lenacapavir should be offered within combination prevention that includes condoms, testing, treatment as prevention, harm reduction, and options like cabotegravir and the dapivirine ring.

Matching tools to local patterns of risk will make prevention fair and effective.

Equity should stay front and center so adolescents, sex workers, men who have sex with men, transgender people, and people who inject drugs can choose what works for them.

Good policy can turn a promising tool into real protection, person by person.

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