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Funding uncertainty looms over lenacapavir for low-income

countries despite FDA approval hopes

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Global Fund aims to raise $18 billion amid PEPFAR funding

doubts

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Lenacapavir pricing crucial for access in low-income

countries,

AIDS group says

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Elation turns to dismay for researcher over Trump funding

cuts

By Julie Steenhuysen and Deena Beasley

May 30 (Reuters) - Gilead Sciences ( GILD ) says it still plans

to supply its twice-yearly injection for preventing HIV

infection in low-income countries if it wins U.S. approval

despite funding uncertainty over the Trump Administration's

pullback in aid spending.

Some AIDS experts, including activists and doctors, say the

Gilead drug, lenacapavir, could help end the 44-year-old

epidemic that infects 1.3 million people a year and is estimated

by the World Health Organization to have killed more than 42

million.

An FDA approval decision is expected by June 19 for

lenacapavir, which proved to be nearly 100% effective at

preventing HIV in large trials.

If the Food and Drug Administration green lights the drug,

and its view is seconded by the WHO, the shots could start to

roll out early in 2026 to at least 2 million people in 18

low-income countries based on Gilead's agreement with the U.S.

President's Emergency Plan for AIDS Relief (PEPFAR) and the

Global Fund, a worldwide partnership targeting HIV, tuberculosis

and malaria.

Gilead agreed to provide lenacapavir at cost for

two-to-three years while six generic drugmakers, which were

granted licenses to make the medicine for low-income countries,

ramp up production.

Experts said a successful launch of a long-acting HIV

prevention drug could help stall the epidemic. Until recently,

the only pre-exposure prophylaxis (PrEP) options for people at

high risk of infection were daily pills, requiring careful

adherence to be effective.

"You can foresee a day where there are no new HIV diagnoses.

It doesn't happen if we only do this in the U.S.," Gilead Chief

Commercial Officer Johanna Mercier said. "We need to make sure

we have a global approach to this launch."

PEPFAR being part of the effort is Gilead's intent and goal,

Mercier said. "Unfortunately, if they're not part of that mix,

our goal is still to meet that objective of 2 million people

getting access."

Wall Street has a close eye on lenacapavir, one of the

highest-profile drugs to undergo FDA review since President

Donald Trump named Robert F. Kennedy Jr. as health secretary and

promised to upend the status quo.

Most of the drug's profits are expected in the U.S., with

annual sales reaching $1 billion by next year, according to

analysts' estimates compiled by LSEG.

'INCREDIBLE DISMAY'

Whether all of the agreed funding for low-income countries -

most of which are in Africa - will come through is unclear.

Countries that rely on aid are already reeling from funding cuts

by the Trump Administration, including to PEPFAR, and AIDS

researchers are bracing for the worst.

The United Nations program on HIV/AIDS earlier this month

said many HIV prevention programs supported by PEPFAR were

stalled, although services for pregnant and breastfeeding women

were technically exempt from the cuts.

Peter Sands, executive director of the Global Fund, told

Reuters the group intends to fund as much of the lenacapavir

rollout as possible, but it will need to start slowly.

"It's not just the uncertainty over PEPFAR's funding that's

an issue, but the uncertainty over our funding," Sands said,

adding that the group's first priority is treating people

already infected with the deadly virus.

Much will depend on the success of the Global Fund's effort

to raise $18 billion to fund its work from 2027-2029. The U.S.

is its largest donor, committing $6 billion in the previous

funding round. It is unclear what the U.S. may provide this

round, or whether other big governments will step up.

UNAIDS estimates that the permanent discontinuation of HIV

prevention and treatment programs supported by PEPFAR would lead

to an additional 6.6 million new HIV infections between 2025 and

2029.

The U.S. State Department, which oversees PEPFAR, did not

respond to a request for comment.

Gilead declined to comment on its manufacturing cost for

lenacapavir, whose U.S. price is likely to be on par with

current preventive medications at around $25,000 per year. ViiV

Healthcare's Apretude, an injection given every two months,

costs about 124.20 pounds ($168) in low- and middle-income

countries.

Mitchell Warren, executive director of the AIDS nonprofit

AVAC, estimates the eventual annual cost at $100-$120. The lower

the price, the more people who could receive it, he said.

Warren said PEPFAR could still participate, and others may

come forward. The Gates Foundation and the Children's Investment

Fund Foundation are "actively involved in all of these

conversations," he said, as is the Elton John AIDS Foundation.

Linda-Gail Bekker of the University of Cape Town, who led

lenacapavir clinical trials in South Africa and Uganda, said she

was elated when she first saw the findings.

"The huge feeling I have now is one of incredible dismay,"

said Bekker of uncertainty over the Trump administration's

commitment to PEPFAR and HIV prevention in poor nations.

"It felt like the stars were aligning, and one of the stars

has fallen out of the sky."