ViiV Healthcare has filed submissions in the US and EU for the first-ever dispersible formulation of dolutegravir (DTG) for children living with HIV.
If approved, the new formulation will be the first integrase inhibitor available as a dispersible tablet for children living with HIV – “closing the gap between treatment options available for adults and children”, the group said.
Latest statistics show there are 1.7 million children living with HIV, and the majority of AIDS-related deaths in this patient population still occur during the first five years of life.
“The availability of age-appropriate formulations is essential in ensuring children around the world have access to optimal life-saving treatments,” ViiV said.
“By submitting these files to regulators for approval, we believe that we are on the cusp of delivering against our promise to develop dolutegravir in a tablet that can be dispersed simply in water,” commented the firm’s chief executive Deborah Waterhouse.
“We will then aim to make this available, via partnerships, as quickly as possible to children living with HIV worldwide.”
Dolutegravir (on the market under the brand name Tivicay) is an integrase strand transfer inhibitor for use in combination with other antiretroviral (ARV) agents for the treatment of HIV.
Integrase inhibitors inhibit HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration, which is essential for the HIV replication cycle.