Pharma giant agrees to license new HIV prevention drug to 120 countries

Pharmaceutical giant Gilead Sciences approved new license agreements for lenacapavir, an antiretroviral medication which provides near-total protection from HIV infection. 

The drug, packaged as Sunlenca in the US (sold for $42,250 a year for two injections), could soon hit the market for low and lower-middle-income countries as a cheaper, generic copycat drug.  

“Our focus is on making it available as quickly and broadly as possible where the need is greatest,” stated Daniel O’Day, chairman and chief executive officer of Gilead, in a press release. 

The company struck a licensing deal on Thursday (3 October), with six manufacturers in India, Egypt, and Pakistan, following demands from civil rights groups.  

“Lenacapavir has the potential to change the trajectory of the AIDS epidemic. WHO urges all manufacturers to ensure this medicine is available and affordable in all countries; including where new HIV infections are on the rise,” said Director-General of the World Health Organisation (WHO), Tedros Adhanom Ghebreyesus, in an X post/Tweet on Friday. 

The biannual injection provided 100% protection in its interim Phase 3 trial involving over 5,000 women in South Africa and Uganda, indicating promising advancements in HIV prevention through pre-exposure prophylaxis (PrEP).  

Lenacapavir appears to be easier to use and more effective than oral PrEP. While PrEP is a preventive treatment for people at high risk from HIV, that can be taken as a daily pill, Lenacapavir is a twice-yearly injectable treatment.

This makes it more suitable for vulnerable groups such as sex workers, migrants, gay men, trans people, and drug users, who often face barriers to testing and treatment. 

Gilead however has yet to disclose the specific cost of the not-for-profit treatment. 

Researchers at Liverpool University have said it could be produced for $40 a year, with a 30% profit margin — assuming 10 million people use it.  

Some campaigners and HIV activists praised the decision but urged Gilead to expand access to lenacapavir, and improve licensing terms to ensure no one gets excluded from the deal.  

South American countries, including Brazil, Argentina, Peru, and Mexico, were excluded from the agreements, even though they were part of the drug's trial populations. Gilead plans to sell lenacapavir in these countries at a higher price.  

“The Gilead voluntary license agreement excludes most of South America, where the HIV epidemic is rapidly growing, as well as countries in the Middle East, Eastern Europe, and Central and Southeast Asia,” said Leena Menghaney, head of South Asia for the Médecins Sans Frontières Access Campaign.  

According to the UNAIDS AIDSinfo database, a quarter of all HIV infections happen in countries excluded from the licencing agreement.  

“In addition, Gilead’s voluntary licensing agreements limit the number of raw material suppliers for the generic lenacapavir,” said Menghaney. As such, major HIV drug manufacturers in India, China, Argentina, Thailand and Brazil who face patent barriers won't be able to produce or sell the treatment at affordable prices.

[Edited by Rajnish Singh]