Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV

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: January 28, 2016; Last Reviewed: January 28, 2016

Guidelines Development Process

Table 1. Outline of the Guidelines Development Process
Topic Comment
Goal of the guidelines Provide guidance to HIV care practitioners on the optimal use of antiretroviral agents (ARVs) for the treatment of HIV in adults and adolescents in the United States.
Panel members The Panel is composed of approximately 45 voting members who have expertise in HIV care and research, and includes at least one representative from each of the following U.S. Department of Health and Human Services (HHS) agencies: Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resource Services Administration (HRSA), and National Institutes of Health (NIH). Approximately two-thirds of the Panel members are nongovernmental scientific members. The Panel also includes four to five community members with knowledge in HIV treatment and care. The U.S. government representatives are appointed by their respective agencies; other Panel members are selected after an open announcement to call for nominations. Each member serves on the Panel for a 4-year term with an option for reappointment for an additional term. See the Panel Roster for a list of current Panel members.
Financial disclosure All members of the Panel submit a written financial disclosure annually, reporting any association with manufacturers of ARV drugs or diagnostics used for management of HIV infections. A list of the latest disclosures is available on the AIDSinfo website (http://aidsinfo.nih.gov/contentfiles/AA_FinancialDisclosures.pdf).
Users of the guidelines HIV treatment providers
Developer Panel on Antiretroviral Guidelines for Adults and Adolescents—a working group of the Office of AIDS Research Advisory Council (OARAC)
Funding source Office of AIDS Research, NIH
Evidence collection The recommendations in the guidelines are based on studies published in peer-reviewed journals. On some occasions, particularly when new information may affect patient safety, unpublished data presented at major conferences or prepared by the FDA and/or manufacturers as warnings to the public may be used as evidence to revise the guidelines.
Recommendation grading As described in Table 2
Method of synthesizing data Each section of the guidelines is assigned to a working group of Panel members with expertise in the section’s area of interest. The working groups synthesize available data and propose recommendations to the Panel. The Panel discusses all proposals during monthly teleconferences. Recommendations endorsed by the Panel are included in the guidelines.
Other guidelines These guidelines focus on antiretroviral therapy (ART) use for adults and adolescents with HIV. For more detailed discussion on the use of ART for children and prepubertal adolescents (SMR I – III), clinicians should refer to the Pediatric ARV Guidelines.

These guidelines also include a brief discussion on the management of women of reproductive age and pregnant women.
Update plan The Panel meets monthly by teleconference to review data that may warrant modification of the guidelines. Updates may be prompted by new drug approvals (or new indications, dosing formulations, or frequency of dosing), new safety or efficacy data, or other information that may have an impact on the clinical care of patients. In the event of new data of clinical importance, the Panel may post an interim announcement with recommendations on the AIDSinfo website until the guidelines can be updated with the appropriate changes. Updated guidelines are available on the AIDSinfo website (https://www.aidsinfo.nih.gov).
Public comments A 2-week public comment period follows release of the updated guidelines on the AIDSinfo website. The Panel reviews comments received 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 with clinical outcomes and/or validated laboratory endpoints

II: One or more well-designed, non-randomized trials or observational cohort studies with long-term clinical outcomes

III: Expert opinion

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