NEW YORK/MUNICH, JULY 23, 2024—Doctors Without Borders/Médecins Sans Frontières (MSF) and other activists called today at the International AIDS Conference for immediate global action to break US-based Gilead’s monopoly on lenacapavir. Increasing access to this medicine—a twice-yearly injectable for HIV pre-exposure prophylaxis (PrEP)—would not only help prevent individuals from getting HIV, it could also have a significant global health impact.
New data shows that generic lenacapavir could be produced at a price 1,000 times less than Gilead’s price of $42,250 per year. With mass production, costs for generic lenacapavir are estimated to be initially $100 per year, with further reductions to $40 per year as demand increases.
“Lenacapavir could be lifechanging for people at risk of getting HIV and could reverse the epidemic if it is made affordable in the countries with the highest rate of new infections,” said Dr. Helen Bygrave, chronic disease advisor at MSF’s Access Campaign. “MSF would be eager to start offering people lenacapavir in our medical programs, but to do so, we need Gilead to license the drug to other producers through the UN-backed Medicines Patent Pool in order to allow generic production and supply in all low- and middle-income countries.”
Worldwide there are 1.3 million HIV infections every year, with one new infection every 24 seconds. Gilead has released no details about their plans for global access to lenacapavir—beyond one statement. However, 25 percent of all new HIV infections are in Russia, Brazil, Philippines, Ukraine, and Thailand—all countries Gilead routinely excludes from licensing deals.
“Gilead also needs to urgently publish a price for lenacapavir that is affordable for governments and people everywhere,” Dr. Bygrave said. “Research released today shows that one year’s supply of lenacapavir could be sold at a profit for under $100 per person per year, but Gilead currently charges over $42,000 per year in the US. This kind of pricing undermines the potential of this scientific breakthrough and slows the global effort to turn the tide on HIV and AIDS.”
The PURPOSE 1 trial has shown the safety and 100-percent efficacy of lenacapavir in stopping HIV acquisition among cisgender adult and adolescent women. Increasing access to this medicine could be a game-changer for people across the world as it only needs to be taken twice a year instead of daily, making it easier for people to adhere to and protect themselves against HIV.
“100-percent effectiveness demands 100-percent access,” said Asia Russell of Health GAP, a global HIV advocacy organization. “Lenacapavir for HIV prevention is a potentially pandemic defeating intervention. Gilead has a long track record of undermining global access by excluding middle-income countries from voluntary licensing deals and artificially restricting licensees. Therefore, we call on governments to break Gilead’s monopoly, by issuing non-voluntary licenses, wherever Gilead’s patents present a barrier.”
HIV community organizations in India, Argentina, Thailand, and Vietnam have filed eight oppositions against Gilead’s lenacapavir patent applications–the Thai Network of People living with HIV (TNP+), DNP+, Fundación Grupo Efecto Positivo, and the Vietnam Network of People living with HIV (VNP+).
“In India, we will fight Gilead’s patents on lenacapavir so that we have a supply of generics for all low- and middle-income countries,” said Loon Gangte of the Delhi Network of People Living with HIV (DNP+).
