FDA Approves Drug to Treat Infants and Children with HIV
U.S. Food and Drug Administration approved Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for suspension to treat HIV-1 infection in pediatric patients at least four weeks old and weighing at least 3 kg (6.61 pounds) in combination with other antiretroviral treatments.

• The safety and effectiveness of Tivicay and Tivicay PD were supported by a trial that included 75 HIV-1–infected infants, children and adolescents 4 weeks to less than 18 years old.

• At 24 weeks, 62% of pediatric patients taking Tivicay or Tivicay PD had an undetectable viral load (the presence of virus in the blood) and at 48 weeks, 69% had an undetectable viral load.

• Also, on average, study subjects had higher levels of certain cells (CD4 cells) that help the body fight off infection.

• The most common adverse reactions: insomnia, fatigue and headache.

• The FDA is granting the approval of Tivicay and Tivicay PD to ViiV Healthcare.

Source: https://www.fda.gov/news-events/press-announcements/fda-approves-drug-treat-infants-and-children-hiv
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Dr. S●●●●●m S●●●●y P●●●●●l
Dr. S●●●●●m S●●●●y P●●●●●l General Medicine
Excellent news.
Jun 14, 2020Like1