Eu-approved Tivicay PD (dotegravir dispersible tablets): treatment of pediatric patients with ≥ 4 weeks and ≥3 kg!

ViiV Healthcare is an HIV/AIDS drug development company controlled by GlaxoSmithKline (GSK) and Pfizer and Shionogi. Recently, the company announced that the European Commission (EC) has approved Tivicay 5 mg dispersible tablets (dolutegravir, oral suspension dispersible tablets) once a day, suitable for combination therapy with other antiretroviral drugs for ≥ 4 weeks, weight ≥3 kg, untreated (untreated, initial treatment) or treated (treated) but not treated with integrase chain transferase inhibitors (INSTI - untreated, INSTI initial treatment). PEDIATRIC INFECTION OF HIV-1. The approval also includes updated dosage recommendations for Tivicay (10 mg, 25 mg, 50 mg) film-coated tablets for children aged ≥6 years and ≥ 14 kg of HIV-1,
　　In terms of U.S. regulation, Tivicay PD (dotiravir dispersible tablets) was approved by the FDA in June 2020 for use in children who are ≥ 4 weeks old, weigh ≥ 3 kg, newly treated, or have received INSTI-naïve HIV-1 patients. In addition, the FDA has approved the expansion of the Tivicay 50 mg film-coated tablet indications for the treatment of HIV infection in children weighing ≥ 20 kg. It is worth mentioning that Tivicay PD is the first dispersible tablet form dolutegravir approved by the FDA. At the same time, dotegravir is also the first integrase inhibitor that can be used as an oral suspension dispersible tablet for the treatment of children ≥ 4 weeks and a body weight of ≥3 kg.
　　In the US and EU, dolutegravir has previously been approved for use in children aged ≥ 6 years and weighing ≥ 30 kg. By providing young people with age-appropriate formulations, it will expand the reach of dolutegravir and help close the gap between hiv treatment options available to adults and children.
　　In China, dolutegravir sodium tablets (trade name: Twicke) obtained an import registration certificate on December 30, 2015. The drug is indicated for: adults and children over 12 years of age who are treated with human immunodeficiency virus (HIV) infection in combination with other antiretroviral drugs.
　　HIV in children remains a global problem, and children are disproportionately affected by the HIV epidemic. The latest statistics show that 1.7 million children worldwide are infected with HIV, and the majority of AIDS-related deaths among children still occur in the first five years of life. For children, major barriers remain, such as continued mother-to-child transmission, the availability of HIV testing, the slow start of treatment and the inadequate availability of the best paediatric preparations for antiretroviral drugs.
　　The approval is based on data from the P1093 study and the ODYSSEY (PENTA20) study. The studies were conducted in collaboration with the International Network of Pediatric Research (IMPAACT and PENTA-ID) in infants, children and adolescents infected with HIV-1 between the ages of 4 weeks and 18 years. The data showed that the safety, efficacy, and pharmacokinetics of Tivicay and Tivicay dispersible tablets in pediatric patients were comparable to those of adult patients taking dolutegravir. At the 24th week of treatment, 62% of pediatric patients treated with Tivicay and Tivicay PD did not have a detectable viral load (NO HIV virus in the blood); At week 48 of treatment, no viral load was detected in 69% of pediatric patients. Generally speaking
　　Deborah Waterhouse, CEO of ViiV Healthcare, said: "Today's approval is a very important milestone. It enables children to obtain age-appropriate HIV drug preparations.