US paediatric guidelines updated (August 2010)

1 October 2010. Related: Paediatric care, Guidelines.

Polly Clayden, HIV i-Base

The US Department of Health and Human Services (DHHS) Guidelines for the Use of Antiretroviral Agents in Pediatric Infection were updated on August 16 2010. Key revisions to the 23 February 2009 version are:

Diagnosis

Viral diagnostic testing at birth is recommended for high risk infants, for instance, those born to HIV-positive mothers who received no prenatal care and or prenatal antiretroviral therapy or who had viral loads >1000 copies/mL close to the time of delivery. The recommendation for testing HIV-exposed infants 14–21 days, 1–2 months, and 4–6 months remains.

They also recommend that an HIV qualitative RNA assay (APTIMA HIV-1 RNA Qualitative Assay) can be used as an alternative test.

When to start

The guidelines still recommend universal treatment for all infants age one year or less.

Guidance for asymptomatic or mildly symptomatic children with CD4 >25% (or >350 cells/mm3 if older than five years) and viral loads >100,000 copies/mL is strengthened. The current guidelines now “recommend” therapy in this situation compared to “consider” in the previous edition.

They also recommended that therapy can be “considered or deferred” for asymptomatic or mildly symptomatic children with CD4 >25% (or >350 cells/mm3 if older than five years) and viral loads <100,000 copies/mL; previously deferral was recommended in this situation.

They make specific recommendations in the following situations:

• Starting antiretroviral treatment is “recommended” for children age one year or
  less with AIDS or significant symptoms (Clinical Category C or most Clinical Category B conditions), regardless of CD4 percentage/count or viral load.
• Starting treatment is also “recommended” for children one year or above who have reached the age-related CD4 threshold for initiating treatment (CD4 <25% for children age one to five years of age and <350 cells/mm3 for children above five) regardless of symptoms or viral load.
• It is also “recommended” for children one year or above who are asymptomatic or with mild symptoms (Clinical Categories N and A or with Clinical Category B conditions: single episode of serious bacterial infection or lymphoid interstitial pneumonitis) and have CD4 >25% for children age one to five or =350 cells/mm3 for children age five or above and have viral load >100,000 copies/mL.
• Starting may be “considered or deferred” for children one year or above who are asymptomatic or have mild symptoms and who have CD4 >25% for children age one to five and >350 cell/mm3 for children five years old or above and have viral loads <100,000 copies/mL.

What to start with

The guidelines discuss recent data from clinical trials of nevirapine versus lopinavir/ritonavir-based regimens in children with single-dose nevirapine exposure for prevention of mother-to-child transmission. NNRTI-based therapy is not recommended for infants or children age <3 years with single-dose nevirapine exposure.

Darunavir/ritonavir is now recommended as an alternative protease inhibitor for initial therapy in children age >6 years.

Nelfinavir has changed from an alternative protease inhibitor for initial therapy to a protease inhibitor for use in special circumstances in children age >2 years.

Key updates usefully highlighted in yellow throughout the guidelines.

The new guidelines also include a ratings system for strength and quality of evidence and have amended some of the appendices.

Ref: Guidelines for the use of antiretroviral agents in pediatric HIV infection, August 16, 2010. http://aidsinfo.nih.gov/contentfiles/PediatricGuidelines.pdf