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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Clinical and Laboratory Monitoring of Pediatric HIV Infection

Last Updated: May 22, 2018; Last Reviewed: May 22, 2018

Panel's Recommendations for Clinical and Laboratory Monitoring of Pediatric HIV Infection
Panel's Recommendations
  • Absolute CD4 T lymphocyte (CD4) cell count and plasma HIV RNA (viral load) should be measured at the time of diagnosis of HIV and, if a child is not started on antiretroviral therapy (ART) after diagnosis, this monitoring should be repeated at least every 3 to 4 months thereafter (AIII).
  • Antiretroviral (ARV) drug-resistance testing is recommended at the time of HIV diagnosis, before initiation of therapy, in all treatment-naive patients (AII). Genotypic resistance testing is preferred for this purpose (AIII).
  • After initiation of ART, or after a change in ART regimen, children should be evaluated for clinical adverse effects and to support treatment adherence within 1 to 2 weeks, with laboratory testing for toxicity and viral load response recommended at 2 to 4 weeks after treatment initiation (AIII).
  • Children on ART should be monitored for therapy adherence, effectiveness, and toxicities routinely (every 3 to 4 months) (AII*).
  • Additional CD4 cell count and plasma viral load monitoring should be performed for evaluation of children with suspected clinical, immunologic, or virologic deterioration or to confirm an abnormal value (AIII). CD4 cell count can be monitored less frequently (every 6–12 months) in children and youth who are adherent to therapy and have CD4 cell count values well above the threshold for opportunistic infection risk, sustained viral suppression, and stable clinical status for more than 2 to 3 years (AII). Viral load measurement every 3 to 4 months is generally recommended to monitor ART adherence and disease progression (AIII).
  • Phenotypic resistance testing should be used (usually in addition to genotypic resistance testing) for patients with known or suspected complex drug resistance mutation patterns, which generally arise after virologic failure of successive ART regimens (BIII).
  • The absence of detectable resistance to a drug does not ensure that use of the drug will be successful, as mutations may not be detected once the drug has been discontinued. A history of all previously used ARV agents and available resistance test results must be reviewed when making decisions regarding the choice of new agents (AII).
  • Viral co-receptor (tropism) assays are recommended whenever a CCR5 antagonist is being considered for treatment (AI*). Tropism assays should also be considered for patients who demonstrate virologic failure while receiving therapy that contains a CCR5 antagonist (AI*).
  • Absolute CD4 cell count is recommended for monitoring immune status in children of all ages, with CD4 percentage as an alternative for children aged <5 years (AII).
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

Table 3. Sample Schedule for Clinical and Laboratory Monitoring of Children Before and After Initiation of Antiretroviral Therapy
Entry Into Carea Pre-Therapyb ART Initiationc Weeks 1–2 on Therapy Weeks 2–4 on Therapy Every 3–4 Monthsd Only Required  Every 6–12 Monthse ARV Switch
History and Physical
Adherence Evaluation
CD4 Count
Plasma Viral Load
Resistance Testing
CBC with Differential
Chemistriesf
Lipid Panel
Random Plasma Glucoseg
Urinalysis
Hepatitis B Screeningh,i  
a See text for details on recommended laboratory tests to obtain.
b Readiness for ARV adherence is assessed prior to starting ART. If abacavir is being considered as part of the regimen, send HLA-B*5701 testing prior to initiation of that ARV and choose an alternative ARV if HLA-B*5701 is positive (see Abacavir in Appendix A: Pediatric Antiretroviral Drug Information). Genotype resistance testing is recommended if not already performed (see Antiretroviral Drug-Resistance Testing in the Adult and Adolescent Antiretroviral Guidelines). Send tests appropriate to the toxicities expected from each patient’s ART regimen and history (see text).
c If ART is initiated within 30 to 90 days of a pre-therapy lab result, repeat testing may not be necessary.
d CD4 cell count, CBC, and chemistries can be monitored less frequently (every 6–12 months) in children and youth who are adherent to therapy and have CD4 cell values well above the threshold for opportunistic infection risk, sustained viral suppression, and stable clinical status for more than 2 to 3 years. Viral load testing every 3 to 4 months is generally recommended to monitor ARV adherence.
e If lipids have been abnormal in the past, more frequent monitoring might be needed. For patients treated with TDF, more frequent urinalysis should be considered.
f Chemistries refer to a comprehensive metabolic panel.
g Random plasma glucose collected in a gray top tube.
h Recommended when considering starting ARV drugs with activity against hepatitis B, specifically lamivudine-, emtricitabine-, and tenofovir-containing regimens.
i Recommended only when individual previously demonstrated no immunity to hepatitis B.

Key to Acronyms: ART = antiretroviral therapy; ARV = antiretroviral; CBC = complete blood count; CD4 = CD4 T lymphocyte; TDF = tenofovir disoproxil fumarate

Table 4. Primary, FDA-Approved Assays to Monitor Viral Load
Assay Abbott Real Time NucliSens EasyQ v 2.0 COBAS Ampliprep/TaqMan v 2.0 Versant v 1.0
Method Real-time RT-PCR Real-time NASBA Real-time RT-PCR Real-time RT-PCR
Dynamic Range (copies/mL) 40–107 25–107 20–107 37–11x107
Specimen volumea 0.2–1 mL 0.1–1 mL 1 mL 0.5 mL
Manufacturer Abbott bioMerieux Roche Siemens
a Smaller volumes for children can be accommodated.

Key to Acronyms: FDA = Food and Drug Administration; NASBA = nucleic acid sequence-based amplification; RT-PCR = reverse transcription polymerase chain reaction

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