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For U.S. regulatory purposes, Tivicay PD (Dotirave dispersal tablets) was approved by the FDA in June 2020 for groups of people with HIV-1 pediatric infections aged ≥4 weeks, weighing ≥3 kg, first treatment or treatment but inSTI primary treatment.
addition, the FDA has approved the expansion of Thevicay 50 mg film film for use in HIV-infected pediatric ≥ weighing 20 kg.
it's worth noting that Tivicay PD is the FIRST FDA-approved dolutegravir formula.
addition, dolutegravir is the first integrated enzyme inhibitor to be used as a dispersive tablet for oral suspension therapy in children aged ≥4 weeks, weight ≥3 kg).
in the United States and the European Union, dolutegravir has previously been approved for use in children ≥ 6 years of age, weighing ≥ 30 kg.
will expand the scope of dolutegravir and help narrow the gap between hiv treatment options available to adults and children by providing age-appropriate formulas to younger populations.
In China, dolutegravir (doteravir sodium tablets, trade name: Tweekai) was certified as an import on December 30, 2015 for the use of other antiretroviral drugs for the treatment of adults infected with human immunodeficiency virus (HIV) and children over 12 years of age.
hiv is still a global problem, with children disproportionately affected by the HIV epidemic.
latest statistics show that 1.7 million children 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 obstacles remain, such as persistent mother-to-child transmission, availability of HIV testing, slow initiation of treatment, and poor availability of optimal paediatric formulations for antiretroviral drugs.
this approval is based on data from the P1093 study and the ODYSSEY (PENTA20) study.
these studies, in collaboration with the International Network for Paediatric Research (IMPAACT and PENTA-ID), were conducted in infants, children and adolescents between 4 weeks and 18 years of age with HIV-1 infections.
data show that Tivicay and Tivicay dispersion tablets are as safe, effective, pharmacodynamics, and adult patients taking dolutegravir in pediatric patients.
week 24 of treatment, 62 per cent of pediatric patients treated with Tivicay and Tivicay PD did not detect viral load (no HIV in the blood);
, pediatric patients have higher levels of specific cells (CD4 cells) that help the body fight infection.
, chief executive of ViiV Healthcare, said: "Today's approval is a very important milestone in enabling children to access age-appropriate HIV drug formulations.
about 1.7 million children worldwide are infected with HIV and about 100,000 die of AIDS each year, which is why we will not stop working to do everything we can to ensure that every child living with HIV receives treatment. Amanda Ely, ceo of the
Children's HIV Association (CHIVA), said: "As an organization, we continue to work to help young people and families living with HIV cope with the challenges of lifelong treatment, and today's approval helps to achieve this.
this approval is a positive step forward and helps help many HIV-infected children and infants who may find it difficult to take the pills.
" original source: ViiV Healthcare receives EU Marketing Authorisation for the first-ever dispersible-tablet development of dolutegravir, Tivicay, a treatment for children living with HIV in Europe