The United States Food and Drug Administration (FDA) has approved a drug for treating HIV infection in children from 4 weeks of age and weighing more than 3 kilograms.
Two forms of the drug were approved: tablet Tivicay (dolutegravir) and Tivicay PD (dolutegravir) in the form of a tablet, soluble in the mouth. The drug was developed by ViiV Healthcare, which specializes in creating drugs for the treatment of HIV infection. Dolutegravir is the first antiviral drug for treatment from the class of second-generation integrase inhibitors. Previously, dolutegravir was prescribed only to children from 6 years old and weighing more than 30 kg.
According to medportal.ru, both forms of the drug were approved according to a study with HIV-infected infants, children and adolescents aged 4 weeks to 18 years. The average age of patients is 2.5 years. After 24 weeks, 62% of patients taking any form of the drug had an undetectable viral load, after 48 weeks their number increased to 69%. In addition, most subjects had a fairly high level of CD4 cells.
The manufacturer of the drug is confident that the widespread use of the new drug will increase the possibilities for treating and reducing the viral load in patients with HIV infection of different ages.
According to the company, to date, at least 1.7 million children worldwide are living with HIV infection, and most AIDS deaths occur within the first 5 years.