Today, The Medicines Patent Pool and Gilead Sciences, Inc reported signing of a licensing agreement on the expansion of access to Bictegravir.
License to the innovative drug of integrase inhibitors class – Bictegravir (BIC) is currently being considered by the European Union and the United States as a component of the combined HIV drug with the intake: “1 pill once a day”.
According to the website of The Medicines Patent Pool after endorsing the drug in the United States, this license will allow to develop and produce available generic drugs containing BIC, in the expanded list of 116 countries with low- and middle-income, which now includes Belarus and Ukraine.
Vladimir Zhovtyak, President of ECUO: “The international team of the East Europe and Central Asia Union of People Living with HIV from 15 countries of the EECA region welcomes the expansion of the voluntary license on Bictegravir, Tenofovir (TAF) and other innovative HIV drugs for patients in Ukraine and Belarus, which have a series of barriers in access to affordable forms of innovative drugs for people living with HIV. We support the strategy of the Medicines Patent Pool on the expansion of access to affordable drugs for HIV, TB and hepatitis C at countries of our region”.
A combined drug with intake “1 pill once a day” BIC / FTC / TAF (bictegravir / emtricitabine / tenofovir alafenamide) is on Phase 3 of the studies involving both adults and children.
Today, the Medicines Patent Pool signed the licensing agreements with 13 producers of generic counterparts of the branded drugs TDF, EVG, COBI, FTC and TAF, which by sublicense allow spreading more than four billion medicines, containing TDF in 124 countries with low- and middle-income.
Let’s note that earlier in April, ECUO published on its website the Position Statement regarding the application of European approaches to the HIV treatment in the countries of Eastern Europe and Central Asia, and in September in Poland presented The concept of ECUO on access to treatment involving all stakeholders of the European region.
Information reference
Bictegravir is an integrase inhibitor (INI) drug, is a component of new HIV drug with optimized reception: 1 pill once a day. The research of drug resistance profile showed its high activity at the impact on a wild-type HIV, and on those types that are resistant to drugs of NRTIs, NNRTIs, and inhibitors protease classes. Bictegravir showed excellent resistance to strong resistance mutations to INI, doing better than dolutegravir, and, obviously, raltegravir and elvitegravir.