AEGiS-GMHC: Treatment Briefs: Ritonavir Approved for Children

Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.

Treatment Briefs: Ritonavir Approved for Children

Treatment Issues, Vol 11, No 3; March 1997
Dave Gilden

The FDA also granted approval for a pediatric ritonavir formulation on March 14. In so doing, the agency increased the number of protease inhibitors available for children from zero to two in one day (see above for nelfinavir). Dosing recommendations are based on safety data collected from ongoing studies of children aged two to 16. The safety of ritonavir in children under two has not been established. When taking ritonavir, children unfortunately suffer from the same long list of side effects and drug-drug interactions as adults do. The evaluation of ritonavir's antiviral effect in children is still in progress. An interim report at this winter's Fourth Conference on Retroviruses and Opportunistic Infections (abstract 722) indicated that ritonavir's antiviral activity in children was similar to that in adults.

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