Lenacapavir was nearly 100% effective in preventing HIV in trials
The US Food and Drug Administration
on Wednesday approved Gilead Sciences lenacapavir, a twice-yearly injection,
for preventing HIV infection in adults and adolescents at high risk of
contracting the deadly virus.
Investors and AIDS activists had been
eagerly awaiting the regulatory decision for the drug seen as convenient enough
to help end the 44-year-old HIV epidemic. It will be sold under the brand name
Yeztugo in the US at a list price of $28,218 a year.
Lenacapavir, part of a class of drugs known as capsid
inhibitors, proved nearly 100 per cent effective at preventing HIV in large
trials last year, raising new hope of interrupting transmission of the virus
that infects 1.3 million people a year.
Yeztugo "will only be as
effective as it is accessible and affordable," Kevin Robert Frost, CEO of
the Foundation for AIDS Research, said in a statement, calling on Gilead and
the US government to make sure people who want lenacapavir can get it.
Gilead said it is working to secure health insurer coverage.
It said it will provide co-pay assistance for eligible insured people, and the
drug may be available free of charge for some under its program for the
uninsured.
Medications to prevent HIV, known as
pre-exposure prophylaxis, or PrEP, are widely available. But most are daily
pills, including low-cost generic versions of Gilead's older drug Truvada, that
require strict adherence to be effective.
Gilead said Yeztugo is priced in line with other branded
drugs. "This is a milestone moment," said Gilead Chief Executive
Daniel O'Day of the approval. "We believe that lenacapavir is the most
important tool we have yet to bend the arc of the epidemic and move this
epidemic into the history books," O'Day said.
Availability of a twice-yearly HIV prevention tool is "a
huge advance," that could help change the course of the epidemic, Dr
Raphael Landovitz, director of the UCLA Centre for Clinical AIDS Research &
Education, said in an email. But he said the product's high launch price
"is almost certainly going to complicate payor coverage and access."
Gilead has plans for a rapid launch in the US as well as a wider rollout of the
drug in collaboration with global partners.
Gilead's chief commercial officer, Johanna Mercier, said the
company's "end game" is to normalise PrEP usage, both in the US and
other countries, including low-income African nations where the virus is most
prevalent.
Citi Research analyst Geoff Meacham said he expects Yeztugo's
launch to be slow and steady, reaching annual sales of $2.8 billion by 2030.
Mercier said she expects around 75 per cent of US insurers,
including government health plans, will cover lenacapavir for PrEP within about
six months, with the number rising to 90 per cent within 12 months of launch.
The drug is currently sold as a treatment in the US under the brand name
Sunlenca for patients with advanced disease that has become resistant to other
drugs.
Pepfar cuts
In December, the President's Emergency Plan for AIDS Relief
(PEPFAR) under then-President Joe Biden signed an agreement with the Global
Fund to Fight AIDS, Tuberculosis and Malaria to provide the treatment to as
many as two million people for three years if it won US regulatory approval for
prevention.
That would allow for unprecedented early access to a
state-of-the-art treatment, as six generic drugmakers that have licensed the
product from Gilead gear up for production of low-cost versions in 120 resource-limited
countries.
AIDS activists have viewed the drug as a way to significantly
slow the epidemic, but cuts to PEPFAR by the Trump administration have raised
concerns about the US government's commitment to the rollout.
O'Day acknowledged that the changes have been "challenging," but said the company has continued to have discussions with both the Global Fund and PEPFAR.
"I believe that there will be
sources of funding for this, and that these organisations will prioritise this
type of prevention," he said.
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