The Medicines Patent Pool (MPP) today announced a licence with Gilead Sciences for bictegravir (BIC), now under review in the United States and the European Union as part of a once-daily, single-tablet HIV regimen. The licence allows manufacturers to develop and sell generic medicines containing BIC, if approved in the United States, in 116 low- and middle-income countries where more than 30 million people live with HIV.
Greg Perry, Executive Director of the Medicines Patent Pool said that Bictegravir-containing combinations could offer improved, simplified treatment options, crucial for people living in resource-limited settings.
Bictegravir is an integrase inhibitor in the same class as dolutegravir (DTG) and elvitegravir (EVG), also licensed to the MPP. A once-daily, single-tablet regimen containing BIC along with emtricitabine (FTC) and tenofovir alafenamide (TAF), BIC/FTC/TAF is currently under investigation in adults as well as children. In Phase 3 studies, BIC/FTC/TAF demonstrated high rates of viral suppression with no treatment-emergent resistance through 48 weeks among treatment-naïve adults and among adults with undetectable viral loads who switched regimens.
Gregg Alton, Executive Vice President at Gilead Sciences, said: “The once-daily, single-tablet BIC/FTC/TAF regimen has the potential to simplify the management of HIV, and we are committed to promoting its access globally. MPP licensees with the rights to manufacture certain of Gilead’s agents, including TAF and now BIC, will be able to produce the single tablet for low- and middle-income countries shortly after its approval in the United States.”
Lelio Marmora, Executive Director of Unitaid, MPP’s funder, said that through the joint HIV licensing programme, millions stand to benefit from quality-assured generics of new optimised treatment regimens.