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Home > Topics > WHO Charts and Tables > Switching to Second-Line ARV Regimens
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Laboratory Parameters for Monitoring Infants and Children at Baseline, Before and During ART

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Routine Monitoring of Children on ART

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Once a child is on ART, in addition to the parameters used before ART (except for confirmation of HIV infection status), clinical assessment should cover the child's and caregiver's understanding of the therapy as well as anticipated support and adherence to the therapy. Observation of the child's responses to therapy should also include symptoms of potential drug toxicities or treatment failure. Particularly important signs of infants' and children's responses to ART include the following:

  • improvement in growth in children who have been failing to grow;
  • improvement in neurological symptoms and development in children with encephalopathy or who have been demonstrating delay in the achievement of developmental milestones; and/or
  • decreased frequency of infections (bacterial infections, oral thrush and/or other opportunistic infections).

The frequency of clinical monitoring depends on the response to ART but should be at a minimum be at weeks 2, 4, 8 and 12 after starting ART and then every 2-3 months once the child has stabilized on therapy. In infants and children who were started on ART on the basis of a presumptive clinical diagnosis of severe HIV disease, HIV infection status should be confirmed as soon as possible.

Laboratory assessment of CD4 is desirable every six months or more frequently if clinically indicated (see table below). The TLC is not suitable for the monitoring of therapy because a change in its value does not reliably predict treatment success. In infants and children initiated on AZT-containing first-line regimens the measurement of haemoglobin should be performed during the first few months of treatment (at weeks 4, 8 and 12 after initiation of ART) or in a symptomdirected approach. Tests of liver function (ie, liver enzymes) are recommended during the first few months of treatment in infants and children receiving nevirapine or who have coinfection with hepatitis viruses or are on hepatotoxic medications. When choosing other laboratory parameters, clinical symptoms should be taken into consideration for assessing the response to therapy. Some routine monitoring tests may be advisable in accordance with the specific drugs used, but laboratory monitoring of adverse events should largely be directed by clinical symptoms (see Annexes F and G of Report). It should be noted that an inability to perform laboratory monitoring should not prevent children from receiving ART.

Laboratory Parameters for Monitoring Infants and Children at Baseline, Before and During ART
Diagnosis and Monitoring Laboratory Tests Baseline (At Entry into Care) At Initiation of First-Line or Second-Line ARV Regimen Every Six Months As Required or Symptom-Directed
HIV diagnostic testing: virological and Ab testing X -- -- --
Haemoglobin a X X -- X
WBC and differential b X X -- X
%CD4 or absolute CD4 cell count c X X X X
Pregnancy testing in adolescent girls X X d -- X
Full chemistry (including, but not restricted to, ALT, e liver enzymes, renal function, glucose, lipids, amylase, lipase and serum electrolytes) f -- -- -- X
HIV viral load measurement g -- -- -- X
a - Haemoglobin monitoring at weeks 4, 8 and 12 after initiation of ART is recommended by some experts if AZT is used.
b - Monitoring at weeks 4, 8 and 12 after initiation of ART is optional.
c - Children not yet eligible for ART should be monitored with CD4 every six months. For infants and children who develop new or recurrent WHO stage 2 or 3 events or whose CD4 approach threshold values the frequency of CD4 measurement can be increased. %CD4+ is preferred in children <5 years of age.
d - Pregnancy testing may be needed for adolescent girls prior to initiating a regimen containing EFV.
e - The predictive value of pre-emptive liver enzyme monitoring is considered very low by some experts. WHO recommends liver enzyme monitoring in a symptom-directed approach. However, regular monitoring during the first three months of treatment and symptom-directed measurement of liver enzymes thereafter has been considered by some experts for children on nevirapine-based regimens, or for adolescent girls with CD4 values over 250 cells/mm 3 and for infants and children coinfected with hepatitis B or hepatitis C virus or other hepatic disease.
f - Regular monitoring (every six months) of full chemistry, particularly lipid levels, liver enzymes and renal function, should be considered for infants and children on second-line drugs.
g - At present, viral load measurement is not recommended for decision-making on the initiation or regular monitoring of ART in resource-limited settings. Tests for assessment of HIV RNA viral load can also be used to diagnose HIV infection, and to assess discordant clinical and CD4 findings in children suspected of failing ART.
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