Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Diagnosis of HIV Infection in Infants and Children

Last Updated: November 15, 2017; Last Reviewed: November 15, 2017

Panel’s Recommendations Regarding Diagnosis of HIV Infection in Infants and Children
Panel's Recommendations
  • Virologic assays (i.e., HIV RNA and HIV DNA nucleic acid tests) that directly detect HIV must be used to diagnose HIV infection in infants and children younger than 18 months with perinatal and postnatal HIV exposure; HIV antibody tests should not be used (AII).
  • RNA or DNA polymerase chain reaction (PCR) testing are recommended equally for most patients; RNA PCR is recommended for known maternal non-subtype B virus (AII).
  • Virologic diagnostic testing is recommended for all infants with perinatal HIV exposure at the following ages:
    • 14 to 21 days (AII)
    • 1 to 2 months (AII)
    • 4 to 6 months (AII)
  • Additional virologic diagnostic testing at birth should be considered for infants at higher risk of perinatal HIV transmission (AIII) and at 2 to 4 weeks after cessation of antiretroviral prophylaxis (BIII).
  • A positive virologic test should be confirmed as soon as possible by a repeat virologic test on a second specimen (AII).
  • Definitive exclusion of HIV infection in non-breastfed infants is based on 2 or more negative virologic tests, with 1 obtained at age ≥1 month and 1 at age ≥4 months, or 2 negative HIV antibody tests from separate specimens obtained at age ≥6 months (AII).
  • Some experts confirm the absence of HIV infection at 12 to 18 months of age in children with prior negative virologic tests by performing an HIV antibody test to document loss of maternal HIV antibodies (BIII).
  • Since children aged 18 to 24 months with perinatal HIV exposure occasionally have residual maternal HIV antibodies, definitive exclusion or confirmation of HIV infection in children in this age group who are HIV antibody-positive should be based on an HIV nucleic acid test (AII).
  • Diagnostic testing in children with non-perinatal exposure only or children with perinatal exposure aged >24 months relies primarily on the use of HIV antibody (or antigen/antibody) tests; when acute HIV infection is suspected, additional testing with an HIV nucleic acid test may be necessary to diagnose HIV infection (AII).
Note: The National Clinical Consultation Center provides consultations on issues related to the management of perinatal HIV infection (1-888-448-8765; 24 hours a day, 7 days a week).
Rating of Recommendations: A = Strong; B = Moderate; C = Optional

Rating of Evidence: I = One or more randomized trials in children† with clinical outcomes and/or validated endpoints; I* = One or more randomized trials in adults with clinical outcomes and/or validated laboratory endpoints with accompanying data in children† from one or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes; II = One or more well-designed, nonrandomized trials or observational cohort studies in children† with long-term outcomes; II* = One or more well-designed, nonrandomized trials or observational studies in adults with long-term clinical outcomes with accompanying data in children† from one or more similar nonrandomized trials or cohort studies with clinical outcome data; III = Expert opinion

† Studies that include children or children/adolescents, but not studies limited to post-pubertal adolescents

Figure 1. Recommended Virologic Testing Schedules for Infants Exposed to HIV by Perinatal HIV Transmission Risk

diagnosis

Low Risk: Infants born to mothers who received standard ART during pregnancy with sustained viral suppression (usually defined as confirmed HIV RNA level below the lower limits of detection of an ultrasensitive assay) and no concerns related to maternal adherence.

Higher Risk: Infants born to mothers living with HIV who did not receive prenatal care, did not receive antepartum or intrapartum ARVs, received intrapartum ARV drugs only, mothers who initiated ART late in pregnancy (late second or third trimester), were diagnosed with acute HIV infection during pregnancy, who had detectable HIV viral loads close to the time of delivery, including those who received combination ARV drugs and did not have sustained viral suppression.

*For higher-risk infants, additional virologic diagnostic testing should be considered at birth and 2 to 4 weeks after cessation of ARV prophylaxis (i.e., at 8–10 weeks of life).

NAT= nucleic acid test

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