Lenacapavir: can two jabs a year end the HIV epidemic?

• Two jabs a year could help prevent HIV infections
• Lenacapavir has won US and EU approval
• But advocates worry for those at risk in poor countries

BERLIN - Two jabs a year of a groundbreaking, new anti-HIV drug could be a game changer in the global fight against the virus but experts worry it will be out of reach for those who most need it.

Lenacapavir, which is the world's first twice-yearly preventative treatment for HIV, has won marketing authorisation in the United States and the European Union (EU) - negotiations over pricing will help determine where else it might be used.

Here's what you need to know about the revolutionary U.S.-made drug and its potential to tame a global epidemic.

How can lenacapavir help prevent HIV infections?

Epidemiologists say preventing new infections is key to controlling the epidemic, particularly among groups at increased risk: gay and bisexual men, transgender people, sex workers, pregnant and breastfeeding women, and people who inject drugs.

Until now, two different pills taken daily had been approved in several countries for pre-exposure prophylaxis (PrEP) and made available to high-risk groups for free or at a low price.

But daily pills pose challenges.

People can forget or be stymied by a lack of privacy; some patients might also struggle to access supplies due to stigma around HIV or discrimination against certain groups of patients.

Public health specialists hope the twice-yearly lenacapavir injection could help circumvent some of these obstacles.

Trials showed lenacapavir proved nearly 100% effective at preventing HIV, raising hopes it could slow a virus that infects 1.3 million people a year four decades after it was detected.

Where is lenacapavir being rolled out?

In July, the World Health Organization recommended lenacapavir as an additional PrEP option for HIV prevention.

The injection has been available in the United States since June, costing more than $28,000 a year. Some insurers refuse to cover the drug, arguing it's too expensive compared to pills.

In the EU, the European Commission in August approved the drug for PrEP among adults and adolescents at increased risk, and now its maker, Gilead Sciences, needs to negotiate pricing terms with health systems in individual countries.

Last month, Gilead said it had filed for regulatory review of the injection for PrEP with health authorities in Australia, Brazil, Canada, South Africa and Switzerland, and will do the same in Argentina, Mexico and Peru.

This month, the U.S. State Department announced a plan to bring lenacapavir to market "at cost" in high-burden HIV countries, hoping to reach 2 million people over three years.

Jeremy Lewin, senior State Department official for foreign assistance, said at a news briefing that the U.S. government has agreements with 12 countries benefiting from PEPFAR, a global HIV programme, to receive doses of lenacapavir.

He did not say which countries.

From El Salvador and Nigeria, Zimbabwe and Indonesia, more than 50 countries receive support from PEPFAR, many of them in sub-Saharan Africa, the region that is worst hit by HIV.

What are the challenges?

The global HIV response has been disrupted by a U.S. decision to slash foreign aid, including HIV-related funding. The cuts have hit testing, prevention and treatment.

PEPFAR no longer funds HIV prevention for many key groups, such as men who have sex with men, trans people and sex workers.

In many countries supported by PEPFAR, LGBTQ+ people face discrimination accessing healthcare along with criminalisation, and media reports say some people are now testing positive since President Donald Trump's HIV cuts.

The State Department has said the lenacapavir rollout would "focus on preventing mother-to-child transmission".

Contacted by Context, it declined to say whether LGBTQ+ people would have the same access.

Public health advocates say the rollout should be more inclusive and ambitious, since many low-income countries might not be able to afford what is an expensive drug.

"We have to ensure that the most number of people in the most number of places get lenacapavir," said Jirair Ratevosian, a senior advisor to the United States Global AIDS Coordinator under former president Joe Biden.

"We should be putting over 40 million people on lenacapavir around the world if we really want to control the epidemic."

(Reporting by Enrique Anarte in Berlin; Editing by Lyndsay Griffiths.)