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DHHS Issues Updated Pediatric Antiretroviral Treatment Guidelines

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On August 11, 2011, the U.S. Department of Health and Human Services (DHHS) issued the latest revision of its Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.

Some of the key updates from the previous (August 2010) version include:

  • Revised recommendations on When to Initiate Therapy, increasing the CD4 T-cell threshold from < 350 cells to < 500 cells/mm3 for asymptomatic children age 5 and older, matching the current adult guidelines.
  • Updates in What Drugs to Start, including a discussion of factors to consider when selecting an initial antiretroviral regimen for children, focusing on non-nucleoside reverse transcriptase inhibitor (NNRTI) vs protease inhibitor-based regimens.
  • Recommendation of lopinavir/ritonavir (Kaletra) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) as the preferred initial regimen for children age 14 days to 3 years, with nevirapine (Viramune) now considered an alternative.
  • Addition of boosted atazanavir (Reyataz) plus 2 NRTIs as a preferred initial regimen for children age 6 or older (joining lopinavir/ritonavir).
  • Preferred initial dual-NRTI backbone regimens for initial therapy include abacavir (Ziagen) plus lamivudine or emtricitabine for children age 3 months or older, and tenofovir (Viread) plus lamivudine or emtricitabine for adolescents age 12 years or older, or zidovudine (AZT; Retrovir) plus lamivudine or emtricitabine at any age; didanosine (ddI; Videx) plus lamivudine or emtricitabine was added as an alternative.
  • The newly approved NNRTI rilpivirine (Edurant) is currently not recommended for children due to lack of data on pediatric dosing and safety and lack of a pediatric formulation.
  • New section on management of children with ongoing adherence problems resulting in virological failure, including use of lamivudine (3TC; Epivir) or emtricitabine (FTC; Emtriva) alone as an interim “bridging regimen.”
  • Urinalysis has been added as a recommended baseline laboratory evaluation, with re-evaluation every 6-12 months.
  • New sections on central nervous system toxicity, peripheral nervous system toxicity, gastrointestinal side effects, and kidney toxicity to tables of antiviral adverse events and management recommendations.

All changes are described in at the beginning of the guidelines document (What’s New in the Guidelines) and are highlighted throughout.

The DHHS Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children is accepting feedback on the latest guidelines revisions until August 30, 2011. Send comments with the subject line "Comments on Pediatric Guidelines" to JLIB_HTML_CLOAKING .

8/12/11

Reference

Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection (http://aidsinfo.nih.gov/contentfiles/PediatricGuidelines.pdf). August 11, 2011.

Other Source

AIDSInfo. Updated HHS Pediatric Antiretroviral Treatment Guidelines Now Available in PDF and HTML Formats. AIDSinfo At-A-Glance 7(33). August 11, 2011.