FDA approves dolutegravir dispersive tablets for childhood AIDS treatment

, July 8, 2020 /PRNewswire
/ -- ViiV Healthcare has received approval from the U.SFood and Drug Administration (
FDA) Tivicay (dolutegravir) tablets and Tilutegravir tablets for the treatment of HIV-1 in infants and childrenthe approved dispersive tablet formulation, which allows routruvir, is used in combination with other antiretroviral therapy for primary pediatric patients over four weeks of age and weighing more than 3 kgFDAalso extended the use of approved 50 mg thin-film coating Routwe tablets in children with AIDS patients weighing 20 kg and abovePhoto Source: Darwin Laganzon from PixabayDorutwe is currently the first integrated enzyme inhibitor to be used as a dispersed tablet for oral suspension in children, previously approved in the United States for 6-year-olds weighing more than 30 kgAccording to ViiV Healthcare, integrative enzyme inhibitors inhibit HIV integration enzymes by binding integrated enzyme active sites and prevent chain transfer procedures for retrovirus DNA integration, which is necessary for the HIV replication cycle"Early treatment is important for infants and young children living with HIV," said Debra Birnkrant, director of the FDA'sCenter for Drug Evaluation and Antiviral ResearchChildren may be infected with HIV more quickly than adultsWhile the incidence of HIV infection in children continues to decline, early access to effective treatment is essential for infants and children living with HIVTaking Tivicay and Tivicay PD once a day can help patients and caregivers better adhere to the treatmentThe safety and effectiveness of the two formulations of the drug supported by a trial featuring 75 infants, children aged four weeks to 18 years of age Deborah Waterhouse, chief executive of ViiV Healthcare, said: "Developing and delivering age-appropriate formulations is critical to ensuring that children have access to life-saving HIV treatment at an early age and in their upbringing The support of our partners is an integral part of this regulatory approval We now need to continue our efforts to ensure that children around the world who need this new decentralized formula have access to it, in line with our mission not to leave any one person living with HIV behind ( BioValleyBioon.com) References: FDA approves oedtablet tablet sgoff of dolutegravir for HIV in children