FDA approves first Tivicay dispersive tablet preparation to treat HIV-1 infant infection

Recently, the Fda approved ViiV Healthcare's Tivicay PD (dolutegravir) first dispersive tablet formula, can be used in combination with other antiretroviral drugs to treat at least 4 weeks of age, weight of at least 3 kg, previously untreated or treated with enzyme transferenzyme inhibitors, but not the treatment of integrated enzyme statiferase inhibitors type 1 immunodeficiency virus (HIV-1) infectionAt the same time, the FDA has approved an extended indications to expand the use of approved Tivicay 50mg film wraps in HIV pediatric patients weighing 20 kg and abovethis approval is based on two global multicenter 2/3 clinical trials IMPAACT P1093 (NCT03016533) and ODYSSEY (Penta20) (NCT02259127)The P1093 study was conducted in the United States, Brazil, Thailand, South Africa, Zimbabwe, Kenya and Tanzania for patients between 4 weeks and 18 years of age in dolutegravir safety, tolerance and dose determination registration studiesThe ODYSSEY study conducted randomized controlled efficacy trials of first- and second-line therapy based on dolutegravir in pediatric patients aged 4 weeks to 18 years in Europe, South America, Thailand, Uganda, Zimbabwe and South Africa, lasting 96 weeksBoth studies were based on working with the World Health Organization (WHO) to verify the safe dose of dolutegravir in HIV-infected infants and young childrenWHO based on the hypothesis dispensing protocol sconfirmed by the P1093 and ODYSSEY trial results, using a description of the dosing plan for existing and future formulationsDolutegravir (DTG) is an oral antiretroviral drug that works with other drugs to treat HIV/AIDSIntegration enzyme inhibitors inhibit HIV integration by binding to the integration enzyme activity site and blocking the chain transfer step of retrovirus DNA integration, which is critical to affecting the HIV replication cycleThe drug can also be used as part of post-exposure prevention to prevent potential post-exposure HIV infectionCurrently, the extended indications of Tivicay PD and the existing Tivicay 50mg film coating are still under review by the European Medicines AgencyPreviously, dolutegravir was recommended in the United States for children under the age of six who weighed more than 30kgThe approval will expand the use of dolutegravir by providing age-appropriate preparations to younger populations and help close the gap between adult and child HIV treatment optionsHIV infection among childrenremains a global problem, with the latest statistics showing that at least 1.7 million children worldwide are infected with the diseaseDeborah Waterhouse, chief executive of ViiV, said: "The availability of Tivicay dispersal tablets will make it easier for young children to take, and we now need to continue our efforts to ensure that this new dispersal formulation is available to children around the world who need itthrough a voluntary licensing policy, ViiV has allowed the free production and sale of dolutegravir generics in all underdeveloped, low- and middle-income, sub-Saharan African countries and some African countries around the world Mylan and Macleods Pharmaceuticals have obtained licenses for the production of dolutegravir generics for paediatrics, accelerating the development, registration, production and supply of Tivicay imitation dispersed formulations Source: 1, ViiV's Tivicay Approved for Children as Young as 4 Weeks with HIV 2, US approves tablet tablet firstible odg tighesie