The Medicines Patent Pool (MPP) and ViiV Healthcare have announced an extension of their current licensing agreement to increase access to dolutegravir (DTG, Tivicay, ViiV Healthcare), to four countries with patents – Armenia, Moldova, Morocco and Ukraine – that were not covered initially.
Under the agreement, MPP sub-licensees can now sell in countries that are home to 94% of people living with HIV in the developing world.
In 2014, ViiV Healthcare granted MPP two non-exclusive licences for DTG: one for the production of the medicine for adults and another for children. Both licences permit generic manufacturers based anywhere in the world to manufacture DTG and to combine the medicine with other drugs to develop fixed-dose combinations (FDCs). To date, nine generic manufacturers have signed MPP sub-licences for DTG and are actively developing the treatment.
DTG is considered a significant advancement in HIV treatment. The medicine does not require boosting and has a good barrier to resistance, and efficacy and tolerability profile at very small doses. Moreover, the medicine can be used for patients that have never taken HIV therapy as well as for many that have developed resistance to their current regimens. The World Health Organization recommended DTG as an alternative first-line treatment for adults in 2015.