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: April 14, 2020; Last Reviewed: April 14, 2020
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
|Laboratory Testing||Entry Into Carea||Pre-Therapyb||ART Initiationc||Weeks 1–2 on Therapy||Weeks 2–4 on Therapy||Every 3–4 Monthsd||Every 6–12 Monthse||Virologic Failure (Prior to Switching ARV Regimens)|
|Medical History and Physical Evaluationf||√||√||√||√||√||√||√|
|Plasma Viral Load||√
|CBC with Differential||√
|Random Plasma Glucoseh||√||√|
|Pregnancy Test for Women of Childbearing Agej||√||√|
a See text for details on recommended laboratory tests to perform.
b A patient’s ability to adhere to an ARV regimen is assessed prior to starting ART. When ABC is being considered as part of the regimen, send HLA-B*5701 testing prior to initiating ABC and choose an alternative ARV drug if the patient is HLA-B*5701 positive (see the Abacavir section in Appendix A: Pediatric Antiretroviral Drug Information). Genotype resistance testing is recommended if it has not already been performed (see Drug-Resistance Testing in the Adult and Adolescent Antiretroviral Guidelines). Send tests that are appropriate for the toxicity profile that is associated with the patient’s ARV regimen and the patient’s medical history (see text).
c If ART is initiated within 30 days 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, who have CD4 cell count values that are well above the threshold for OI risk, and who have had sustained virologic suppression and stable clinical status for more than 2–3 years. Viral load testing every 3–4 months is generally recommended to monitor ARV adherence.
e If lipid levels have been abnormal in the past, more frequent monitoring may be needed. For patients treated with TDF, more frequent urinalysis should be considered.
f Pay special attention to changes in weight that might occur after altering an ARV regimen. Weight gain or weight loss may occur when using some ARV drugs (see Table 15h–Lipodystrophies and Weight Gain).
g Chemistries refer to a comprehensive metabolic panel.
h Random plasma glucose is collected in a gray-top blood collection tube or other designated tube.
i This screening is only recommended for individuals who have previously demonstrated no immunity to HBV and who are initiating a regimen that contains ARV drugs with activity against HBV, specifically 3TC, FTC, TAF, or TDF.
j See the Adult and Adolescent Antiretroviral Guidelines, as well as Preconception Counseling and Care for Women of Childbearing Age Living with HIV in the Perinatal Guidelines.
Key: 3TC = lamivudine; ABC = abacavir; ART = antiretroviral therapy; ARV = antiretroviral; CBC = complete blood count; CD4 = CD4 T lymphocyte; FTC = emtricitabine; HBV = hepatitis B virus; OI = opportunistic infection; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate
|Assay||Abbott Real Time||NucliSens EasyQ v2.0||COBAS AmpliPrep/TaqMan v2.0||Versant v1.0||Aptima HIV-1 Quant Assay|
|Method||Real-time RT-PCR||Real-time NASBA||Real-time RT-PCR||Real-time RT-PCR||Real-time TMA|
|Dynamic Range||40–107 copies/mL||25–107 copies/mL||20–107 copies/mL||37–11x107 copies/mL||30–107 copies/mL|
|Specimen Volumea||0.2–1 mL||0.1–1 mL||1 mL||0.5 mL||≥0.4 mL
|Manufacturer||Abbott Laborotories||bioMerieux||Roche||Siemens||Hologic, Inc.|
a Smaller volumes for children can be accommodated.
Key: NASBA = nucleic acid sequence-based amplification; RT-PCR = reverse transcription polymerase chain reaction; TMA = transcription-mediated amplification