Responding to today's announcement by Gilead on lenacapavir, UNAIDS Executive Director Winnie Byanyima said:
"We welcome Gilead's announcement of licensing the break-through HIV medicine lenacapavir for generic production. To stem the tide of new infections, and protect people most at risk from HIV, including young women and people from marginalised communities, long-acting HIV medicines are vital. Lenacapavir, which requires only two injections per year, could be game changing - 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. At UNAIDS we commit to doing all we can to speed up this process.
Including an African producer in Egypt is also very welcome.
Much more work is still urgently needed to ensure that no one who needs lenacapavir is left behind and that Gilead's commitment to rapid, affordable access is fulfilled.
The exclusion of many middle-income countries from the licenses is deeply worrying and undermines the potential of this scientific breakthrough.
HIV prevention products need to be deployed where new HIV infections are highest - and right now, forty-one percent of new infections are in upper-middle income countries. UNAIDS urges Gilead to secure further licenses for access in all low and middle-income nations.
We welcome Gilead's statement of commitment to non-profit pricing, but we had been waiting eagerly for a specific price. We urge Gilead to disclose it, and to provide full transparency on their costs. Respected researchers have shown it is possible to produce and sell lenacapavir for $100 per patient per year, falling to as little as $40.
Manufacturing this medicine in African countries with the highest HIV rates is crucial for sustainability and Gilead should include manufacturers in countries like South Africa where there is strong production capacity. We at UNAIDS stand ready to assist.
UNAIDS urges Gilead to secure further licenses for access in all low and middle-income nations.
We urge Gilead also to do all it can to make lenacapavir viable for treatment in low- and middle-income countries, including working together with researchers to test new combinations. Over 30 million people worldwide taking HIV treatment every day deserve long-acting options. We recognize that Gilead has included treatment use in the license, where some companies have not, but we urge that they remove the current limitation in the license to "heavily treatment-experienced patients." To support scientists and manufacturers worldwide, licenses should not be limited to specific uses.
Leaving no one behind is how to unlock lenacpavir's full potential, fulfil Gilead's promise, protect a generation from HIV and bring forward the end of the AIDS pandemic."
