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 Sunleca 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.”
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.”
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.