Food and Drug Administration - February 29, 2008
Richard Klein & Kimberly Struble
When to initiate therapy, including
• Change in treatment recommendations for when to initiate therapy in HIV-infected children <12 months of age
• Reduction from 4 to 3 age bands for recommendations on when to initiate therapy (<12 months, 1 to <5 years, and 5 years and older)
• Changes in immunologic thresholds for when to start in children 1 year or older
• Timing of diagnostic testing in HIV-exposed infants
• The pediatric drug appendix and hyperlink on drug preparations, new dosage formulations, and pediatric studies
• Recently approved antiretrovirals: maraviroc (including a new coreceptor tropism assay section), raltegravir, and etravirine
• Revised antiretroviral toxicity hyperlink with new tables detailing toxicity management
Changes are highlighted in yellow throughout the text and tables.
The updated guidelines are available for download from the Pediatric Guidelines section of the AIDSinfo Web site. You can also request to receive them by mail or email from the AIDSinfo Order Publications section.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
080229
FD080205
SOURCE: Food and Drug Administration (FDA).
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