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Lenacapavir, given as a twice-yearly injection, has shown strong results for HIV
prevention. Photograph: Nardus Engelbrecht/AP
View image in fullscreen
Lenacapavir, given as a twice-yearly injection, has shown strong results for HIV
prevention. Photograph: Nardus Engelbrecht/AP
Fair AccessGlobal development



‘GAMECHANGER’ HIV PREVENTION DRUG TO BE MADE AVAILABLE CHEAPLY IN 120 COUNTRIES

Gilead Sciences announces deal to manufacture generic versions of lenacapavir,
but critics say it excludes many countries where incidence is highest



Supported by

About this content
Kat Lay, Global health correspondent
Thu 3 Oct 2024 14.13 CESTLast modified on Mon 7 Oct 2024 11.48 CEST
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Cheaper versions of the “gamechanger” HIV prevention drug lenacapavir are to be
made available in 120 low- and middle-income countries, manufacturer Gilead
Sciences has announced.

However, campaigners said the deal “abandons” many countries with a high HIV
burden, particularly in Latin America, and urged transparency over exact
pricing.



Lenacapavir, given as a twice-yearly injection, has shown strong results for HIV
prevention. It stopped infection in a trial involving girls and women in South
Africa and Uganda, and offered almost complete protection in a second trial that
mainly involved men across Argentina, Brazil, Mexico, Peru, South Africa,
Thailand and the US.

Gilead has faced pressure to make lenacapavir available as soon as possible and
as cheaply as possible globally. Already approved as a treatment for HIV, it is
sold for $42,250 a year under the name Sunlenca in the US. Researchers say it
could be profitably produced for just $40 (£30) a patient, a year.

The company said it had signed agreements with six manufacturers to make and
sell generic lenacapavir in 120 “high-incidence, resource-limited” countries.
These are mainly lower-income countries.

It said it would also bridge the gap until those manufacturers were up and
running by providing Gilead-supplied product, prioritising registration in 18
countries with high HIV rates including Botswana, South Africa and Thailand.

However, Dr Mohga Kamal-Yanni, policy co-lead for the People’s Medicines
Alliance, criticised the decision to arrange licences directly rather than
through the UN-backed Medicine Patent Pool. The agreements came with “draconian
conditions” that could make it harder for people in excluded countries to get
hold of the drug, she said.

“Behind the seemingly large numbers of countries included in the licence, Gilead
is largely abandoning upper middle-income countries, where new infections are
highest, with nearly all of Latin America left out,” she said.

“The countries that have been excluded can use their legal rights to overcome
intellectual property restrictions with a compulsory licence. However, Gilead’s
agreement prevents the six licensee companies from selling to those countries.
Moreover, this route is fraught with difficulties and can face legal challenges
from industry. But it is a country’s right, and should be used if necessary.”

View image in fullscreen
Winnie Byanyima, UNAids executive director, called for access to lenacapavir for
all who would benefit. Photograph: Xinhua/Rex/Shutterstock

Winnie Byanyima, UNAids executive director, said: “Lenacapavir, which requires
only two injections per year, could be gamechanging – if all who would benefit
can access it.

“We applaud Gilead for licensing the medicine without waiting for registration,
which should be the norm. We are battling a pandemic and the speed at which
generic versions come to market will dictate whether this medicine can really be
transformative.”

HIV drug could be made for just $40 a year for every patient
Read more

Byanyima warned that 41% of new infections were in upper middle-income
countries, and excluding them from the licences “is deeply worrying and
undermines the potential of this scientific breakthrough”.

She said UNAids was also still waiting for a specific price and full
transparency on Gilead’s costs.

The generic manufacturers are India’s Dr Reddy’s Laboratories, Emcure
Pharmaceuticals and Hetero Labs, as well as US-based Viatris’ unit Mylan,
Egypt’s Eva Pharma and Pakistan-based Ferozsons Laboratories. UNAids said it
would also like to see agreements in countries with high HIV rates such as South
Africa.

Gilead said it will start filing for global regulatory approval for lenacapavir
as a prevention regimen for HIV by the end of this year.

Explore more on these topics
 * Global development
 * Fair Access
 * Aids and HIV
 * Drugs
 * news

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