Criteria for commencing antiretroviral therapy in children
There are difficulties in making a laboratory diagnosis of HIV infection in infants aged <18 months. This is due to persistence of maternal antibody thus requiring virologic tests to make definitive diagnosis of HIV infection in this age group. The recommendations for initiation of ARV therapy in children are therefore divided into categories related to age and availability of virologic diagnostic tests. When CD4 cell assays are available, use of CD4 cell percentage is recommended for children for decision-making on ARV treatment rather than absolute CD4 cell count because it varies less with age. The availability of virologic testing is desirable, but not absolutely necessary to the development of recommendations for the initiation of therapy in young infants.
For WHO Paediatric clinical staging see table 7.1 and 7.2
Initiation of Infants under 18 months
For HIV-sero-positive infants aged <18 months, initiation of ARV therapy is recommended in:
Infants with WHO Stage 3 or 4 disease and CD4 percentage <20% in absence of virological confirmation of diagnosis.
Infant with virologically-proven infection (using HIV DNA PCR, HIV RNA assay, or immune-complex dissociated p24 antigen) and has WHO Paediatric Stage 3 (e.g., clinical AIDS) irrespective of CD4%.
Infant is in WHO Paediatric Stage 1 or 2 disease with CD4 <20%.
Infants < 18 months with neither virological confirmation nor CD4 percent available, with WHO Paediatric Stage 3 or 4. In such cases, HIV antibody testing must be repeated at age 18 months to definitively confirm that the child is HIV infected; only children with confirmed infection should have ARV therapy continued.
Figure 7: Clinical Eligibility Criteria for ART in Children under 18 months
* HIV exposed child is one who has a positive antibody test (ELISA or rapid) but not confirmed to actually be infected
Initiation of treatment for Children over 18 months
For children over 18 months of age, a positive antibody test is an indication of HIV infection since any acquired antibodies from the mother would have degenerated, and breastfeeding has typically stopped. Initiation of ART is therefore recommended if:
WHO Paediatric Stage 3 or 4 HIV disease, irrespective of CD4 %; or
WHO Paediatric Stage 1 or 2 disease and CD4 <15%
All children in stage 3 could be started on ARV therapy even if a CD4 percent is not available, but attempt should be made to do a CD4 percent as soon as possible for monitoring. In the interim the child should be monitored clinically. When in doubt, the attending clinician should consult or refer the child.
Figure 8: Clinical Eligibility Criteria for ART in Children over 18 months
The penetration of ARVs into human breast milk in lactating women has not been quantified for most ARVs. Although some ARVs, such as Nevirapine, are known to be present in breast milk, the concentration and quantity of drug that would be ingested by the infant would be less than needed to achieve therapeutic levels. Thus, if a breastfeeding infant is ill enough to require ARV treatment ARVs at standard pediatric doses should be initiated regardless of whether the mother is receiving ARV therapy or not. Infected breastfeeding infants whose mothers are receiving ARV therapy may ingest sub-therapeutic levels of some ARVs, and this could lead to development of drug resistance in the infant’s virus. ARVs should not be administered during the breastfeeding period to infants with documented HIV infection who do not require ARV therapy themselves. Further research is needed to address whether administration of drugs to infants may decrease resistance or alter response to therapy.