Approval of a cheap version of HIV-prevention shot lenacapavir raises
hopes in low-income countries
[November 03, 2026]
By LAURA UNGAR
The U.S. Food and Drug Administration has approved a generic version of
the world’s only twice-a-year shot to prevent HIV — a big step toward
making the drug available inexpensively and more quickly in 120 low- and
middle-income countries.
The announcement was made on Monday morning by the manufacturer and
organizations that helped to speed up development of the medication,
called lenacapavir.
The drug is expected to cost $40 a year per person in the countries
where it will be available, the same price as daily preventive pills
available now. But the shots are much more convenient than the pills
because they’re needed much less frequently and they nearly eliminated
new infections in two groundbreaking studies of people at high risk.
People don’t always take their daily dose of medication, “and if you do
not take it, you cannot get protected against HIV,” said Carmen Pérez
Casas, HIV lead for the grant-making organization Unitaid, a global
health agency. “With lenacapavir, we are much more hopeful.”
Ultimately, advocates said, the medication should help drive down cases
of HIV and AIDS — and deaths. According to the World Health
Organization, 41 million people worldwide were living with HIV and
570,000 died from HIV-related causes last year.
With an affordable, high-quality generic medication now available, “we
could help to scale this to the 20 million people around the world who
need PrEP,” prescription medicine taken by people at risk of HIV before
being exposed to the virus, said Carolyn Amole, who leads the HIV
program for the Clinton Health Access Initiative, a global health
organization.
“And if we scale to those levels,” she added, “we can actually begin to
bring an end to the HIV epidemic.”
Generic lenacapavir can’t be sold in the U.S. because a brand-name
version, Yeztugo, made by Gilead Sciences and approved last year, is
still protected by a patent. The U.S. list price for that version,
meaning the cost before insurance, is $28,218 a year. Gilead officials
say that’s similar to some other types of PrEP, which stands for
pre-exposure prophylaxis.
The new generic was approved by the FDA under a longstanding practice
designed to ensure the quality of HIV-related drugs provided to other
countries by the U.S. government. Approval of a drug by the U.S. FDA can
speed regulatory approval in many other countries. The approval is
considered “tentative,” the FDA's standard designation for generics
while the originator remains under patent.
Until now, Gilead has been the sole supplier of lenacapavir. Demand has
outstripped supply in low- and middle-income countries, though Gilead
has established royalty-free licensing agreements with six generic
manufacturers to enable greater production. Those voluntary licenses
cover a specific set of countries in sub-Saharan Africa, Asia and Latin
America.
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A nurse prepares a syringe before injecting a patient with the new
HIV prevention drug lenacapavir at the ART clinic at Mbarara City
Council Health Center IV in western Uganda, Aug. 21, 2026. (AP
Photo/Hajarah Nalwadda)
 “We share the sense of urgency
around expanding access to lenacapavir for HIV prevention,” a Gilead
spokesperson said in a statement. “We believe we have enabled the
fastest and most sustainable path to expanding access for
communities most affected by HIV.”
The generic was developed by India-based Dr. Reddy’s Laboratories
under an agreement brokered by Unitaid, the Clinton Health Access
Initiative and Wits RHI, a health research institute in Africa. The
partners sought to accelerate development and make the drug
available at an affordable price.
Common side effects with lenacapavir include injection site
reactions, headache and nausea. People also must be tested for HIV
prior to starting the drug and with each injection; drug-resistant
HIV has been identified when used by people with an undiagnosed HIV
infection.
“For any kind of PrEP … you need to have HIV testing in advance,”
said Saiqa Mullick, director of implementation science with Wits RHI.
“For many of the low- and middle-income countries, that is a rapid
test.”
Generic lenacapavir should start to become available in some places
within weeks, those helping with the effort said, although it could
take a bit longer in countries that require the drug to go through
their own approval processes before people can start taking it.
Generic versions made by the other manufacturers have yet to be
approved by FDA.
“The work is not done. Now, we need the funding to actually buy it
for everyone who needs it and then we need to do the hard work of
getting it to the millions of people who need it and want it,” Amole
said. “But this is a great milestone.”
Casas said she’s optimistic that scientific advances — along with
political will and funding — can help the world curb HIV.
“Now,” she said, “we have the tools.”
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Associated Press writer Gerald Imray in Cape Town, South Africa,
contributed to this story.
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