“Gamechanger” HIV prevention drug to be available cheaply in 120 countries | Global development

According to manufacturer Gilead Sciences, cheaper versions of the “game-changing” HIV prevention drug lenacapavir will be available in 120 low- and middle-income countries.

But activists said the deal “fails” many countries with high HIV burdens, particularly in Latin America, and called for transparency over exact pricing.

Lenacapavir, administered as a twice-yearly injection, has shown strong results in HIV prevention. It stopped infection in a trial involving girls and women in South Africa and Uganda and provided near-complete protection in a second trial involving mostly men in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States.

Gilead was under pressure to make lenacapavir available worldwide as quickly and as cost-effectively as possible. It is already approved to treat HIV and is sold in the US under the name Sunleca for $42,250 a year. Researchers say it could be made profitably for as little as $40 (£30) per patient per year.

The company said it has signed agreements with six manufacturers to produce and sell generic lenacapavir in 120 countries with “high incidence and limited resources.” These are predominantly low-income countries.

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

However, Dr. Mohga Kamal-Yanni, policy co-leader of the People's Medicines Alliance, the decision to award licenses directly rather than through the United Nations-backed Medicine Patent Pool. The agreements come with “draconian conditions” that could make it harder for people in excluded countries to get the drug, she said.

“Behind the seemingly large number of countries included in the license, Gilead largely leaves out the upper middle-income countries where new infections are highest, leaving out almost all of Latin America,” she said.

“The excluded countries can use their legal rights to overcome intellectual property restrictions with a compulsory license. However, Gilead's agreement prevents the six licensee companies from selling to these countries. Furthermore, this path is fraught with difficulties and may face legal challenges from industry. But it is the law of a country and should be used when necessary.”

UNAids chief executive Winnie Byanyima said: “Lenacapavir, which requires just two injections a year, could be a game-changer – if everyone who would benefit from it has access to it.”

“We applaud Gilead for licensing the drug without having to wait for registration, which should be the norm. We are fighting a pandemic and the speed at which generic versions come to market will determine whether this drug can be truly transformative.”

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

She said UNAids was also still waiting for a concrete price and full transparency about Gilead's costs.

The generic manufacturers are the Indian companies Dr. UNAids said it also wanted agreements in countries with high HIV rates, such as South Africa.

Gilead said it would begin filing for global regulatory approval for lenacapavir as an HIV prevention therapy by the end of this year.