April 26, 2025 • 10 mins
Lenacapavir could be a gamechanger in the fight against infection. But US funding cuts have thrown the rollout of the twice-yearly injection into doubt.
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Speaker 1 (00:00):
A miracle h I V drug may not reach the
women who need it most. By Jason Gale and Janis
Q read by Pamela Lawrence. By midday, the shaded courtyard
at Whitcope and Clinic in Johannesburg is crowded. In an
adjacent room, women sit quietly on plastic chairs with babies
on their laps, waiting inside to avoid the worst of
(00:23):
the heat. Sitchen Gassiwee Sibanda is among them, her weak
old newborn tucked against her chest and her eight year
old son playing by her side. She's here for her
infant son's check up and to collect her pills that
prevent HIV infection. I have to protect myself and the baby,
said Sibonda, who began taking the daily pre exposure prophylaxis
(00:47):
or PREP during her most recent pregnancy. She knows of
many women in her township, however, who won't consider the
medication because of perceived stigma, fear of being questioned by
their partner, or simply the challenge of remembering a daily regimen.
Sibonda hasn't heard about the injectable drug lena kapavir, tested
(01:08):
on South African women in trials that prevents HIV with
just two doses a year. The most promising HIV prevention
tool in a generation would empower women to discreetly protect themselves,
making it a potential game changer in the fight against infection.
But lena Kampavir's rollout has been thrown into doubt by
(01:30):
US President Donald Trump's sweeping cuts to foreign aid. With
future US funding for global health uncertain, it's unclear who
will pay for widespread deployment of the shots developed by
Gilead Sciences Inc. And how many people they will reach
in the countries that need them most. If funding for
critical programs is not restored in its original form, there
(01:53):
may be a risk of taking US back decades, said
Kenneth and Gouray, an HIV researcher in Kenya and president
elect of the International Aid Society. Without US support, the
number of people who are going to access it, especially
in the regions that need it most, will be compromised.
As recently as December, the Biden administration and global donors
(02:16):
pledged that at least two million people over three years
would get affordable and equitable access to lenikapavir, contingent on
regulatory approval by the US Food and Drug Administration. Just
weeks later, the Trump administration dismantled the US Agency for
International Development and threw into doubt the future of the
(02:37):
President's Emergency Plan for AIDS Relief PEPPHAR, a landmark initiative
credited with saving more than twenty six million lives over
two decades. The US helped ensure the world was on
the verge of controlling HIV as a public health threat,
said in Gorey, this could have cemented their legacy, but
(02:57):
now people may remember that the US pulled out at
the moment when everything was moving so well. HIV first
emerged in nineteen eighty one as a terrifying, mysterious disease
and at the time, a death sentence. It took until
nineteen eighty three for scientists to identify the virus behind it,
and another two years before a test became available. In
(03:20):
the decades that followed, scientific progress has been drastic. Anti
retroviral treatment has turned HIV into a manageable condition, and
preventable tools like prep now allow people to protect themselves
before exposure, but that progress hasn't always reached everyone equally.
When the first effective treatments became available, in the mid
(03:42):
nineteen nineties, they were priced at around twenty thousand dollars
per person per year. People in the world's richest countries
began to survive, while millions in developing countries died waiting
for costs to come down. Between nineteen ninety five and
two thousand four, more than twelve million million people in
Africa lost their lives to AIDS. Only when generic versions
(04:05):
were introduced did the price of treatment fall in some
countries to under forty dollars per year. That history looms large,
and the question now is whether the same cycle will
be repeated. Science Magazine called lena kapavir the biggest scientific
breakthrough of twenty twenty four. It is already approved in
the US, European Union and several other countries as a
(04:29):
treatment for people with multi drug resistant HIV. If lena
kapavir is approved by the FDA for use as a
pre exposure prophylaxis in June, as Gilead anticipates, it would
become the first and only HIV prevention shot administered just
twice a year. Gilead is now trying to develop a
(04:49):
once yearly formulation. The real excitement is in preventing transmission,
said Wesley Sundquist, a biochemist at the University of Utah
whose research in the the mid nineties helped make the
drug possible. You never get infected in the first place.
His lab was among the first to map the structure
of the HIV capsid, the protein shell that surrounds the
(05:12):
virus's genetic material. Lena capavir blocks that structure, stopping the
virus before it can replicate. Sunquist said Gilead made and
tested more than four thousand compounds to develop the drug,
describing it as heroic work. Winnie Bienima, executive director of
the Joint United Nations Program on HIV AIDS UNAIDS, calls
(05:36):
lenakpavir a miracle that has the potential to break down
barriers that stop many people from seeking prep. In twenty
twenty three, one point three million people were infected with
HIV globally, most of them in Africa and mostly among
girls and young women. She said they won't come forward
unless it is something so discreet that protects them from
(05:59):
being judged. In October, Gilead announced it would allow generic
manufacturers to begin producing low cost versions of Lena kapavir
for one hundred twenty resource limited countries with high HIV transmission.
A generic version of the drug, mass produced for ten
million people could cost as little as forty one dollars
(06:19):
per person per year. In the US, the price is
expected to be more than twenty four thousand dollars. Gilead
has taken unprecedented steps to initiate a comprehensive global access
strategy before filing for regulatory approvals. The Foster City, California
based company said in an emailed statement that program, however,
(06:41):
excludes some middle income countries with rising HIV infections, including Peru,
where clinical research was also conducted. Trump's executive order freezing
foreign aid spending for ninety days through the global aid
sector into chaos, and future funding for key programs such
as b PEPFAR remains uncertain. Founded by George W. Bush
(07:04):
in two thousand and three, PEPFAR has been the largest
commitment by any nation to address a single disease, and
it supports about ninety percent of people starting prep Worldwide.
Congressional authorization for pepfar expired on March twenty fifth, while
a limited waiver allows it to carry on HIV treatment
(07:24):
and care for pregnant and breastfeeding women. Confusion and uncertainty
has led to clinic closures, staff layoffs, and interruptions in
care across multiple countries. The Global Fund to Fight AIDS
Tuberculosis Similaria, which typically receives about a third of its
budget from the US, also faces challenges. The Fund is
(07:45):
seeking to raise eighteen billion dollars for work out to
twenty twenty nine. European support is faltering amid budget constraints
caused by the war in Ukraine, and future US commitments
remain undecided. If we we have to take on more
of the responsibility of deploying lenikapavir, we will do what
we can do, said Peter Sands, the Global Funds executive director.
(08:09):
Obviously it will depend on our own resourcing. Preventing a
single infection in a young person can save decades of
costly treatment, said Sans, a former chief executive officer of
UK bank Standard Chartered PLC. Deploying at scale a really
effective prevention tool is a kind of no brainer, he added.
(08:31):
The world would be crazy not to take full advantage
of a tool that allows us to bring forward the
end of AIDS, said Sans. History would judge US harshly
if we don't. A State Department spokesman said all PEPFAR
funded services remain under review, and didn't say whether the
US would support Lena Kapavir's rollout. Bienima at UNAIDS is
(08:54):
urging the Trump administration not to cut funding for the
Global Fund and PEPFAR. It was a Republican president who
started the revolution in treatment by launching PEPFAR, she said.
Now another Republican president could lead the revolution in prevention.
She sees it as a smart investment, one that saved lives,
(09:15):
strengthens American leadership, and generates returns at home. It's a
win win, she said, but we have to act now.
Linda Gail Becker, who led late stage trials across South
Africa and Uganda for Lena Kapavir, said two thousand young
women in South Africa contract HIV each week, underscoring the
(09:36):
need for effective, discreete prevention tools. The idea that African
women will once again be last in line is truly
not acceptable, said the Cape Town physician and scientist, who
wept with joy in mid twenty twenty four when she
learned the drug was one hundred percent effective and received
a standing ovation, presenting the results at an AIDS conference
(09:59):
in Munich in July. Meanwhile, work continues at the Whitcopen Clinic,
which relies on funding from the u S, South Africa's
Department of Health and private donors for its h I
V services. Sibonda noticed fewer staff on her last visit
and is concerned about the future. I'm a mother of two,
(10:19):
I'm not working. I cannot afford a doctor, she said,
adjusting her newborn in her arms as she waited to
collect her pills. I worry that there's no more funds.
A miracle h I V drug may not reach the
women who need it most. By Jason Gale and Janis
Q read by Pamela Lawrence. By midday, the shaded courtyard
at Whitcope and Clinic in Johannesburg is crowded. In an
adjacent room, women sit quietly on plastic chairs with babies
on their laps, waiting inside to avoid the worst of
(00:23):
the heat. Sitchen Gassiwee Sibanda is among them, her weak
old newborn tucked against her chest and her eight year
old son playing by her side. She's here for her
infant son's check up and to collect her pills that
prevent HIV infection. I have to protect myself and the baby,
said Sibonda, who began taking the daily pre exposure prophylaxis
(00:47):
or PREP during her most recent pregnancy. She knows of
many women in her township, however, who won't consider the
medication because of perceived stigma, fear of being questioned by
their partner, or simply the challenge of remembering a daily regimen.
Sibonda hasn't heard about the injectable drug lena kapavir, tested
(01:08):
on South African women in trials that prevents HIV with
just two doses a year. The most promising HIV prevention
tool in a generation would empower women to discreetly protect themselves,
making it a potential game changer in the fight against infection.
But lena Kampavir's rollout has been thrown into doubt by
(01:30):
US President Donald Trump's sweeping cuts to foreign aid. With
future US funding for global health uncertain, it's unclear who
will pay for widespread deployment of the shots developed by
Gilead Sciences Inc. And how many people they will reach
in the countries that need them most. If funding for
critical programs is not restored in its original form, there
(01:53):
may be a risk of taking US back decades, said
Kenneth and Gouray, an HIV researcher in Kenya and president
elect of the International Aid Society. Without US support, the
number of people who are going to access it, especially
in the regions that need it most, will be compromised.
As recently as December, the Biden administration and global donors
(02:16):
pledged that at least two million people over three years
would get affordable and equitable access to lenikapavir, contingent on
regulatory approval by the US Food and Drug Administration. Just
weeks later, the Trump administration dismantled the US Agency for
International Development and threw into doubt the future of the
(02:37):
President's Emergency Plan for AIDS Relief PEPPHAR, a landmark initiative
credited with saving more than twenty six million lives over
two decades. The US helped ensure the world was on
the verge of controlling HIV as a public health threat,
said in Gorey, this could have cemented their legacy, but
(02:57):
now people may remember that the US pulled out at
the moment when everything was moving so well. HIV first
emerged in nineteen eighty one as a terrifying, mysterious disease
and at the time, a death sentence. It took until
nineteen eighty three for scientists to identify the virus behind it,
and another two years before a test became available. In
(03:20):
the decades that followed, scientific progress has been drastic. Anti
retroviral treatment has turned HIV into a manageable condition, and
preventable tools like prep now allow people to protect themselves
before exposure, but that progress hasn't always reached everyone equally.
When the first effective treatments became available, in the mid
(03:42):
nineteen nineties, they were priced at around twenty thousand dollars
per person per year. People in the world's richest countries
began to survive, while millions in developing countries died waiting
for costs to come down. Between nineteen ninety five and
two thousand four, more than twelve million million people in
Africa lost their lives to AIDS. Only when generic versions
(04:05):
were introduced did the price of treatment fall in some
countries to under forty dollars per year. That history looms large,
and the question now is whether the same cycle will
be repeated. Science Magazine called lena kapavir the biggest scientific
breakthrough of twenty twenty four. It is already approved in
the US, European Union and several other countries as a
(04:29):
treatment for people with multi drug resistant HIV. If lena
kapavir is approved by the FDA for use as a
pre exposure prophylaxis in June, as Gilead anticipates, it would
become the first and only HIV prevention shot administered just
twice a year. Gilead is now trying to develop a
(04:49):
once yearly formulation. The real excitement is in preventing transmission,
said Wesley Sundquist, a biochemist at the University of Utah
whose research in the the mid nineties helped make the
drug possible. You never get infected in the first place.
His lab was among the first to map the structure
of the HIV capsid, the protein shell that surrounds the
(05:12):
virus's genetic material. Lena capavir blocks that structure, stopping the
virus before it can replicate. Sunquist said Gilead made and
tested more than four thousand compounds to develop the drug,
describing it as heroic work. Winnie Bienima, executive director of
the Joint United Nations Program on HIV AIDS UNAIDS, calls
(05:36):
lenakpavir a miracle that has the potential to break down
barriers that stop many people from seeking prep. In twenty
twenty three, one point three million people were infected with
HIV globally, most of them in Africa and mostly among
girls and young women. She said they won't come forward
unless it is something so discreet that protects them from
(05:59):
being judged. In October, Gilead announced it would allow generic
manufacturers to begin producing low cost versions of Lena kapavir
for one hundred twenty resource limited countries with high HIV transmission.
A generic version of the drug, mass produced for ten
million people could cost as little as forty one dollars
(06:19):
per person per year. In the US, the price is
expected to be more than twenty four thousand dollars. Gilead
has taken unprecedented steps to initiate a comprehensive global access
strategy before filing for regulatory approvals. The Foster City, California
based company said in an emailed statement that program, however,
(06:41):
excludes some middle income countries with rising HIV infections, including Peru,
where clinical research was also conducted. Trump's executive order freezing
foreign aid spending for ninety days through the global aid
sector into chaos, and future funding for key programs such
as b PEPFAR remains uncertain. Founded by George W. Bush
(07:04):
in two thousand and three, PEPFAR has been the largest
commitment by any nation to address a single disease, and
it supports about ninety percent of people starting prep Worldwide.
Congressional authorization for pepfar expired on March twenty fifth, while
a limited waiver allows it to carry on HIV treatment
(07:24):
and care for pregnant and breastfeeding women. Confusion and uncertainty
has led to clinic closures, staff layoffs, and interruptions in
care across multiple countries. The Global Fund to Fight AIDS
Tuberculosis Similaria, which typically receives about a third of its
budget from the US, also faces challenges. The Fund is
(07:45):
seeking to raise eighteen billion dollars for work out to
twenty twenty nine. European support is faltering amid budget constraints
caused by the war in Ukraine, and future US commitments
remain undecided. If we we have to take on more
of the responsibility of deploying lenikapavir, we will do what
we can do, said Peter Sands, the Global Funds executive director.
(08:09):
Obviously it will depend on our own resourcing. Preventing a
single infection in a young person can save decades of
costly treatment, said Sans, a former chief executive officer of
UK bank Standard Chartered PLC. Deploying at scale a really
effective prevention tool is a kind of no brainer, he added.
(08:31):
The world would be crazy not to take full advantage
of a tool that allows us to bring forward the
end of AIDS, said Sans. History would judge US harshly
if we don't. A State Department spokesman said all PEPFAR
funded services remain under review, and didn't say whether the
US would support Lena Kapavir's rollout. Bienima at UNAIDS is
(08:54):
urging the Trump administration not to cut funding for the
Global Fund and PEPFAR. It was a Republican president who
started the revolution in treatment by launching PEPFAR, she said.
Now another Republican president could lead the revolution in prevention.
She sees it as a smart investment, one that saved lives,
(09:15):
strengthens American leadership, and generates returns at home. It's a
win win, she said, but we have to act now.
Linda Gail Becker, who led late stage trials across South
Africa and Uganda for Lena Kapavir, said two thousand young
women in South Africa contract HIV each week, underscoring the
(09:36):
need for effective, discreete prevention tools. The idea that African
women will once again be last in line is truly
not acceptable, said the Cape Town physician and scientist, who
wept with joy in mid twenty twenty four when she
learned the drug was one hundred percent effective and received
a standing ovation, presenting the results at an AIDS conference
(09:59):
in Munich in July. Meanwhile, work continues at the Whitcopen Clinic,
which relies on funding from the u S, South Africa's
Department of Health and private donors for its h I
V services. Sibonda noticed fewer staff on her last visit
and is concerned about the future. I'm a mother of two,
(10:19):
I'm not working. I cannot afford a doctor, she said,
adjusting her newborn in her arms as she waited to
collect her pills. I worry that there's no more funds.
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