Gilead to Distribute Lenacapavir in Top HIV Countries, Critics Unhappy

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Gilead Sciences signed noninclusive, royalty free voluntary licensing agreements with six pharmaceutical manufacturers in Asia and North Africa this week to make and sell generic lenacapavir in 120 high-incidence, primarily low-income countries. While broad, critics say greater access is needed.

The laboratories named in the agreement are:

• Dr. Reddy's Laboratories
• Emcure Pharmaceuticals
• Hetero Labs
• Mylan
• Eva Pharma
• Ferozsons Laboratories

These drug makers will not be charged for the licenses, according to a news release. These agreements cover lenacapavir as part of a preexposure prophylaxis (PrEP) regimen and as an HIV treatment in adults with treatment resistance HIV.

The top 18 countries that account for 70% of global HIV cases are included as part of the 120 countries. They are:

• Botswana
• Eswatini
• Ethiopia
• Kenya
• Lesotho
• Malawi
• Mozambique
• Namibia
• Nigeria
• Philippines
• Rwanda
• South Africa
• Tanzania
• Thailand
• Uganda
• Vietnam
• Zambia
• Zimbabwe

This partnership comes less than a month after results of a second phase 3 clinical trial revealed that 99.9% of the 2,180 total participants treated with lenacapavir did not acquire HIV.

Lenacapavir was approved by the FDA in December 2022 as an HIV treatment. It is given in combination with other antiretrovirals. Treatment begins with an injection and tablets followed by an injection every six months. Gilead currently charges patients $42,250 per year. There is currently no information about how much it will cost as part of a PrEP regimen.

“The agreements advance Gilead’s strategy to enable broad, sustainable access to lenacapavir for preexposure prophylaxis (PrEP) globally if it is approved,” Daniel O’Day, chairman and CEO of Gilead said in the news release.

However, this deal leaves out most middle- and high- income countries including Brazil, Columbia, Mexico, China and Russia that, when combined, account for about 20% of global HIV infections.

People’s Medicines Alliance, an advocacy group, released the following statement in reaction:

“Behind the seemingly large numbers of countries included in the license, Gilead is largely abandoning upper-middle-income countries, where new infections are highest, with nearly all of Latin America left out,” Mohga Kamal-Yanni, M.D., policy co-lead for the People’s Medicines Alliance, said in a news release. “The countries that have been excluded 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 those countries.”

There are currently about 40 million people living with HIV around the world. Last year, an estimated 1.3 million were diagnosed with HIV and about 630,000 died, the WHO reports.