The new formulation of dotilavir is approved by FDA for the treatment of infants and children with HIV infection
Last Update: 2020-06-19
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On the 13th, the U.SFDA approved dolutegravir (tivicay) tablet and tivicay PD (dispersible tablet with suspension) developed by VIV healthcare company to be used in combination with other antiretroviral therapies to treat children with HIV-1 infection aged at least 4 weeks and weighing at least 3 kgThese patients have not been treated with integrated enzyme chain transfer enzyme inhibitors (insti)According to a press release from Viiv healthcare, tivicay PD is the first integrase inhibitor to treat such children in the form of a dispersible tabletDispersible tablets can be rapidly decomposed into suspension in water, which provides convenience for infants to take medicine< br / > dotiravir is a virus integrase inhibitorIt was approved by the FDA in 2013 to treat adult patients with HIV infectionIn China, it was also officially approved for listing in 2016 under the trade name of twickay< br / > the safety and efficacy of tivicay and tivicay PD were supported by a trial involving 75 infants, children and adolescents (4 to 18 years old) infected with HIV-1The average age of patients in the trial was 27 monthsIn this trial, both researchers and subjects knew which treatment was being givenThis trial, and the results of another safety trial conducted at the same time, showed that the safety, efficacy and pharmacokinetics of tivicay and tivicay PD in paediatric patients were comparable to those of adults taking dotiravirAt 24 weeks, 62% of pediatric patients treated with tivicay or tivicay PD had no virus in their bloodAt 48 weeks, 69% of patients could not detect the virus< br / > HIV progresses faster in children than in adults "Although the incidence rate of HIV infection in pediatrics continues to decline, early treatment and effective treatment are crucial for infants and children infected with HIV," said DrDebra Birnkrant, director of the FDA antiviral departmentTivicay and tivicay PD are administered once a day to help patients and caregivers better comply with the treatment regimen Today's approval gives our youngest HIV patients more options to help them live longer and healthier lives " < br / > reference materials: < br / >  FDA approved drug to treat infections and children with HIV Retrieved June 12, 2020, from < br / >  VIV healthcare announcements US FDA approval of the first ever distinct table formula of dolomitegravir, tivay PD, a once daily treatment for children living with HIV < br / >
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