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.
Clinical and Laboratory Monitoring of Pediatric HIV Infection
Last Updated: May 22, 2018; Last Reviewed: May 22, 2018
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
|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||√||√||√||√||√||√||√|
|Plasma Viral Load||√
|CBC with Differential||√
|Random Plasma Glucoseg||√||√|
|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
|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|
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