Zambia Pediatric

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Guidelines for Antiretroviral Therapy of HIV infection in Infants and Children: Towards universal access X. Switching an ARV Regimen in Infants and Children: Treatment Failure that a child with Clinical Stage 3 defining pulmonary or lymph node TB or with severe recurrent presumed bacterial pneumonia should receive appropriate TB or antibacterial therapy before switching regimens, with re-evaluation of the child after

adequate trial of TB or antibacterial therapy to determine the need to switch the ART regimen. In children who are clinically well (i.e. Clinical Stage T1 and T2), a regimen should not be switched if CD4 measurements are not available.

Table 9. Decision-making regarding switching to second line therapy for treatment failure based on availability of CD4 measurement a WHO Paediatric Availability Clinical Stage of CD4 on ARTa measurementsb No CD4

T1 and T2d Event(s)

T3d Event(s)

T4 Event(s)

CD4

Management optionsc • Do not switch regimen • Consider switching regimen only if 2 or more values below age-related threshold for severe immunodeficiencyd are available • Increase clinical and CD4 follow up if CD4 approaches age-related threshold for severe immunodeficiencye

No CD4

a. Consider switching regimene,f

CD4

b. Switching regimen is recommended if CD4 at or below age-related threshold for severe immunodeficiency and particularly if child initially had good immune response to ART

No CD4

c. Switch regimen, regardless of CD4

CD4

d. Switching is generally recommended, but it may not be necessary where CD4 is above age related threshold for severe immune deficiency

Notes: a) It needs to be ensured that the child had at least 24 weeks of treatment trial; adherence to therapy has been assessed and considered to be adequate prior to considering switching to second-line regimen. Additionally, in considering changing treatment because of growth failure, it should be ensured that the child has adequate nutrition, and that any intercurrent infections have been treated and resolved. b) Clinical stages in this table refer to a new or recurrent stage at the time of evaluating the infant or child on ART. c) Where CD4 is available, at least two CD4 measurements should be compared. d) Do not switch regimen if CD4 values are above age-related threshold for severe immunodeficiency. e) Age-related severe immunodeficiency values as defined in Table 5; switching should particularly be considered if values are <15% (12-35 months of age), <10% (36-59 months of age), <100 cells/mm3 (?5 years of age); use of %CD4 in children less than5 years of age and absolute CD4 count after 5 years of age is preferred; if serial CD4 values are available, the rate of decline should be taken into consideration. f) Some T3 conditions (i.e. pulmonary or lymph node tuberculosis and severe recurrent presumed bacterial pneumonia) may need to be treated and do not always indicate the need to switch regimens. g) Viral load determination may be useful to support recognition of treatment failure

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