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# FDA Approves Tivicay for Infants, Children with HIV
- URL: https://www.fdaweb.com/fda-approves-tivicay-for-infants-children-with-hiv/
- Published: 2020-06-12T12:00:00.000Z
- Updated: 2026-09-14T16:18:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146998

FDA has approved ViiV’s Tivicay (dolutegravir) tablets and Tivicay PD tablets for suspension to treat HIV-1 infection in pediatric patients at least four weeks old and weighing at least 6.61 pounds in combination with other antiretroviral treatments. An agency [statement](https://www.fda.gov/news-events/press-announcements/fda-approves-drug-treat-infants-and-children-hiv?utm%5Fcampaign=FDA%20Approves%20Drug%20to%20Treat%20Infants%20and%20Children%20with%20HIV&utm%5Fmedium=email&utm%5Fsource=Eloqua) says the drug is intended for patients who have never been treated for HIV or who have been treated but not with an integrase strand transferase inhibitor class drug.

The safety and efficacy of Tivicay and Tivicay PD were supported by a trial including 75 HIV-1 infants, children, and adolescents. The trial reportedly demonstrated that effectiveness and pharmacokinetics in the pediatric patients were comparable to adults taking dolutegravir.

FDA had granted the ViiV application priority review status.