Gilead announced Wednesday that it will allow certain drug manufacturers to make and sell a generic version of its twice-yearly HIV shot lenacapavir in 120 low- and lower-middle income countries. But the pharma company’s plans won’t make lenacapavir accessible in many key countries where a twice-yearly prevention drug could be transformative for combating the spread of HIV, according to drug access experts.
Two large studies have shown that lenacapavir given twice a year can reduce the risk of acquiring HIV. Lenacapavir made waves earlier this year when Gilead announced that the injection fully prevented HIV in a study with cisgender women, and the striking results led the trial to stop early. A second study showed the drug reduced risk in cisgender men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth.
Lenacapavir is not yet approved anywhere in the world for HIV PrEP (pre-exposure prophylaxis), but Gilead said it plans to begin regulatory filings by the end of this year.
The company is granting six drug manufacturers voluntary licenses to make and sell the drug for PrEP as well as treatment for certain adults with multi-drug resistant HIV, where it is already approved as Sunlenca. The manufacturers include Dr. Reddy’s, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero and Viatris subsidiary Mylan.
In the US, Sunlenca has a list price of $42,250 for the first year and $39,000 every year after that. A study presented in late July showed the drug could be made for $40. When asked about pricing of lenacapavir for PrEP, Gilead said in an email that the drug is experimental and “while we prepare for regulatory filings, it is too early to state the price.”
Gilead said in its press release Wednesday that it’s also prioritizing lenacapavir registration in 18 countries “that represent about 70% of the HIV burden in the countries named in the license,” in order to provide lenacapavir until generics are available.
However, advocates have been calling for Gilead to allow generic production of lenacapavir through the Medicines Patent Pool, a UN-backed program that would enable generic production for all low- and middle-income countries, not just the ones that Gilead has selected.
“It is concerning that Gilead’s latest announcement seems to mention neither upper-middle income countries, where people cannot afford anything like lenacapavir’s current $42,250 price tag, nor a commitment to work with the UN-backed Medicines Patent Pool,” UNAIDS executive director Winnie Byanyima said in a statement in July in response to Gilead’s announcement of the Phase 3 results in cisgender women.
UNAIDS’ press release noted that these upper-middle-income countries account for 41% of new HIV infections and 37% of all people living with HIV. Global estimates say that in 2023, 39.9 million people are living with HIV, including 1.3 million newly infected, while 630,000 died from AIDS-related illnesses last year.
Brook Baker, senior policy analyst for Health GAP and professor emeritus at Northeastern University School of Law, pointed out that several excluded countries are those where Gilead conducted clinical trials, including Argentina, Brazil, Mexico and Peru, but the company has promised access only to trial participants.
He added that the terms of Gilead’s agreement strongly deter manufacturers from making and selling the drug outside of the 120 countries that it has permitted. Baker said that Gilead’s moves “prevent supply to potentially profitable upper-middle-income markets.”
Gilead said in an email Wednesday that it believes that “working directly with our licensees will ensure we are able to rapidly transfer our technology and address challenges as they arise,” and for middle-income countries, it is “exploring several innovative strategies to support access to LEN for PrEP (if approved), including tiered pricing, and are working with payors to establish fast, efficient pathways to help reach people who need or want PrEP.”
Baker said that tiered pricing often comes with “no price transparency” and countries are “negotiating blind” with drug companies.