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.

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Introduction

Last Updated: April 16, 2019; Last Reviewed: April 16, 2019

Guidelines Development Process

Table 1. Outline of the Guidelines Development Process
Topic Comment
Goal of the Guidelines The guidelines provide guidance to HIV care practitioners on the optimal use of antiretroviral (ARV) agents in infants, children, and adolescents in early to mid-puberty (sexual maturity rating [SMR] 1-3) who are living with HIV in the United States.
Panel Members The Panel is composed of approximately 35 voting members who have expertise in the management of HIV infection in infants, children, and adolescents. Members include representatives from the Committee on Pediatric AIDS of the American Academy of Pediatrics and community representatives with knowledge of pediatric HIV infection (e.g., parents and caregivers of children and youth living with HIV). The Panel also includes at least one representative from each of the following Department of Health and Human Services (HHS) agencies: the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Health Resources and Services Administration (HRSA), and the National Institutes of Health (NIH). A representative from the Canadian Pediatric AIDS Research Group participates as a nonvoting, ex officio member of the Panel. The U.S. government representatives are appointed by their respective agencies; nongovernmental members are selected after an open announcement to call for nominations. Each member serves on the Panel for a 3-year term with an option for reappointment. A list of current members can be found in the Panel Roster.
Financial Disclosure All members of the Panel submit an annual financial disclosure statement in writing, reporting any association with manufacturers of ARV drugs or diagnostics used to manage HIV infections. A list of the latest disclosures is available on the AIDSinfo website.
Users of the Guidelines Providers of care to infants, children, and adolescents living with HIV in the United States
Developer Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV—a working group of the Office of AIDS Research Advisory Council (OARAC)
Funding Source Office of AIDS Research, NIH, and HRSA
Evidence Collection A standardized review of recent, relevant literature related to each section of the guidelines is performed by a technical assistance consultant (through funding from HRSA) and provided to individual Panel section working groups. The recommendations are generally based on studies published in peer-reviewed journals. The Panel may occasionally use unpublished data to revise the guidelines, particularly when the new information relates to dosing or patient safety. These data come from presentations at major conferences or from the FDA and/or drug manufacturers.
Recommendation Grading Described in Table 2
Method of Synthesizing Data Each section of the guidelines is assigned to a small group of Panel members with expertise in the area of interest. The members synthesize the available data and propose recommendations to the Panel. The Panel discusses all proposals during monthly teleconferences. Proposals are modified based on Panel discussion and then distributed with ballots to all Panel members for concurrence and additional comments. If there are substantive comments or votes against approval, the recommended changes and areas of disagreement are brought back to the full Panel (by email or teleconference) for additional review, discussion, and further modification to reach a final version that is acceptable to all Panel members. The recommendations in these final versions represent endorsement from a consensus of members and are included in the guidelines as official Panel recommendations.
Other Guidelines These guidelines focus on infants, children, and adolescents in early-to-mid-puberty (SMR 1–3) who are living with HIV. Guidelines for the treatment of adolescents in late puberty (SMR 4–5) are provided by the Panel on Antiretroviral Guidelines for Adults and Adolescents.

Separate guidelines outline the use of antiretroviral therapy (ART) in pregnant women with HIV infection (including maternal and infant interventions to prevent perinatal transmission), ART for nonpregnant adults and postpubertal adolescents with HIV infection, and ARV prophylaxis for those who experience occupational or nonoccupational exposure to HIV. These guidelines are also available on the AIDSinfo website.
Update Plan The full Panel meets monthly by teleconference to review data that may warrant modification of the guidelines. Smaller working groups of Panel members hold additional teleconferences to review individual drug sections or other specific topics (e.g., What to Start). Updates may be prompted by new drug approvals (or new indications, formulations, or frequency of dosing), new significant safety or efficacy data, or other information that may have a significant impact on the clinical care of patients. In the event of significant new data that may affect patient safety, the Panel may issue a warning announcement and post accompanying recommendations on the AIDSinfo website until the guidelines can be updated with appropriate changes. All sections of the guidelines will be reviewed at least once a year, with updates as appropriate.
Public Comments A 2-week public comment period follows the release of the updated guidelines on the AIDSinfo website. The Panel reviews these comments to determine whether additional revisions to the guidelines are indicated. The public may also submit comments to the Panel at any time at contactus@aidsinfo.nih.gov.

Table 2. Rating Scheme for Recommendations
Strength of Recommendation Quality of Evidence for Recommendation
A: Strong recommendation for the statement

B: Moderate recommendation for the statement

C: Optional recommendation for the statement

I: One or more randomized trials in childrena with clinical outcomes and/or validated laboratory endpoints

I*: One or more randomized trials in adults, with clinical outcomes and/or validated laboratory endpoints plus accompanying data in childrena 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 childrena with long-term clinical outcomes

II*: One or more well-designed, nonrandomized trials or observational cohort studies in adults with long-term clinical outcomes plus accompanying data in childrena from one or more smaller nonrandomized trials or cohort studies with clinical outcome data

III: Expert opinion
a These are studies that include children or children and adolescents, but not studies that are limited to postpubertal adolescents.

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