Food and Drug Administration - October 30, 2006
Richard Klein & Kimberly Struble

Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection have been revised. The revision represents a major rewriting of the main document to improve its organization and readability. Because the main document has been almost completely rewritten, there is no highlighting of changes to either its text or tables.

The document's Appendix: Characteristics of Available Antiretroviral Drugs, and Supplement I: Pediatric Antiretroviral Drug Information, have also been updated. Changes to those sections appear highlighted in yellow.

Changes in recommendations include:

• Revised guidelines on when to initiate therapy in antiretroviral-naïve children, with recommendations for four age categories (< 12 months, 1 to < 4 years, 4 to 12 years, and ≥ 13 years).
• Revised discussion and tables of rationale for antiretroviral drug choice for antiretroviral-naïve children, with revised preferred and alternative treatment regimen recommendations.
• Revised recommendations for adolescents, including issues related to drug dosing, use of contraception, pregnancy, and transition into adult care.
• Updated Characteristics of Available Antiretroviral Drugs drug dosing appendix and updated Supplement I: Pediatric Antiretroviral Drug Information, including information on newly approved antiretroviral agents, such as darunavir, and new pediatric studies.

Also new to the guidelines are:

• Recommendations for antiretroviral resistance testing for all antiretroviral-naïve children prior to initiation of antiretroviral therapy.
• New section and table on monitoring of children on antiretroviral therapy and management of antiretroviral toxicity/intolerance.
• New section on management of the treatment-experienced child.
• New section and tables on assessment and management of antiretroviral treatment failure and choice of new antiretroviral regimen in children with treatment failure.
• New section on therapeutic drug monitoring.
• New section on discontinuation or interruption of antiretroviral therapy.
• Inclusion of darunavir information.

The updated guidelines are available on the Pediatric Guidelines page of the Clinical Guidelines section of AIDSinfo.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

SOURCE: Food and Drug Administration (FDA).

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