Doravirine is not yet approved for use in South Africa and in other African countries, but MSD will provide licenses for the registration, commercialisation, and distribution of generic doravirine (100 mg) for use in a single entity tablet and in a fixed-dose combination tablet with lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg) in 86 countries.
These countries include all countries of sub-Saharan Africa, other low- and lower middle-income countries outside of sub-Saharan Africa (as classified by the World Bank), and all least-developed countries (as defined by the United Nations). Nearly 80% of people living with HIV globally reside in these 86 countries.
"These agreements are part of our long-term commitment to work together with others in partnerships that will increase access to our breakthrough medicines for those people who need them most. We have a long history of research and discovery in HIV and we remain committed to making sure people living with HIV benefit from our inventions," says Dr Priya Agrawal, managing director of MSD in South Africa & sub-Saharan Africa.
According to UNAIDS, 38-million people were estimated to be living with HIV worldwide at the end of 2019, with a vast majority of those people residing in low- and middle-income countries, but only an estimated 25.4-million people were accessing antiretroviral therapy as of 2019. There are also 1.7-million additional HIV infections occurring each year. Under the terms of the non-exclusive agreements, the licensee companies can manufacture and supply generic doravirine (100 mg) and the fixed-dose combination of doravirine (100 mg)/lamivudine (300 mg)/tenofovir disoproxil fumarate (300 mg) in designated countries.
