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.
When to Initiate Therapy in Antiretroviral-Naive Children
Last Updated: May 22, 2018; Last Reviewed: May 22, 2018
|<12 Monthsa||Regardless of clinical symptoms, immune status, or viral load||Urgentb treatment (AII except AI for children aged ≥6 weeks to <12 weeks)|
|1 to <6 Years||CDC Stage 3-defining opportunistic illnessesc||Urgentb treatment (AI*)|
|CDC Stage 3 immunodeficiency:d CD4 <500 cells/mm3|
|Moderate HIV-related symptomsc||Treate (AII)|
|CD4 cell countc 500–999 cells/mm3|
|Asymptomatic or mild symptomsc and CD4 cell countc ≥1000 cells/mm3||Treate (AI*)|
|≥6 Yearse||CDC Stage 3-defining opportunistic illnessesc||Urgenta treatment (AI*)|
|CDC Stage 3 immunodeficiency:d CD4 <200 cells/mm3|
|Moderate HIV-related symptomsc||Treatb (AII)|
|CD4 cell countd 200–499 cells/mm3|
|Asymptomatic or mild symptomsc and CD4 cell count ≥500 cells/mm3||Treate,f (AI*)|
|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 and adolescents but not studies limited to post-pubertal adolescents
|Note: Adherence should be assessed and discussed with children who have HIV and their caregivers before initiation of therapy (AIII).
a Treatment of infants aged ≤2 weeks is complex and an area of active investigation. See Antiretroviral Management of Newborns with Perinatal HIV.
b Within 1–2 weeks, including an expedited discussion on adherence.
c See Table 6 for definitions.
d CD4 cell counts should be confirmed with a second test to meet the treatment criteria before initiation of ART.
e More time can be taken to fully assess and address issues associated with adherence with the caregivers and the child prior to initiating therapy. Patients/caregivers may choose to postpone therapy, and on a case-by-case basis, providers may elect to defer therapy based on clinical and/or psychosocial factors, with close patient monitoring.
f For initiation of ART for adolescents aged ≥13 years and SMR of 4 or 5, see the Adult and Adolescent Guidelines.
Key to Acronyms: ART = antiretroviral therapy; CD4 = CD4 T lymphocyte; CDC = Centers for Disease Control and Prevention; SMR = sexual maturity rating
|Stage||Age on Date of CD4 Test|
|<1 Year||%||1 to <6 Years||%||≥6 Years||%|
a The stage is based primarily on the CD4 cell count; the CD4 cell count takes precedence over the CD4 percentage, and the percentage is considered only if the count is missing. If a Stage 3-defining opportunistic illness has been diagnosed (Table 6), then the stage is 3 regardless of CD4 test results.
Source: Centers for Disease Control and Prevention. Revised surveillance case definition for HIV infection—United States, 2014. MMWR 2014;63(No. RR-3):1-10.
Key to Acronyms: CD4 = CD4 T lymphocyte
|Mild HIV-Related Symptoms|
|Children with 2 or more of the conditions listed, but none of the conditions listed in Moderate Symptoms category:
|Moderate HIV-Related Symptoms|
|Stage-3-Defining Opportunistic Illnesses In HIV Infection|
a Only among children aged <6 years.
b Only among adults, adolescents, and children aged ≥6 years.
c Suggested diagnostic criteria for these illnesses, which might be particularly important for HIV encephalopathy and HIV wasting syndrome, are described in the following references: