Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents

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.

Introduction

Last Updated: May 29, 2018; Last Reviewed: May 29, 2018

Guidelines Development Process
Topic Comment
Goal of the guidelines
Provide guidance to HIV care practitioners and others on the optimal prevention and management of HIV-related opportunistic infections (OIs) for adults and adolescents in the United States.
Panel members
The Panel is composed of co-editors who represent the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the HIV Medicine Association of the Infectious Disease Society of America (HIVMA/IDSA), plus Panel members with expertise in HIV clinical care, infectious disease management, and research. Co-editors are appointed by their respective agencies or organizations. Panel members are selected from government, academia, and the healthcare community by the co-editors and assigned to a working group for one or more of the guideline sections based on the member’s area of subject matter expertise. Each working group is chaired by a Panel member selected by the co-chairs. Members serve on the Panel for a 3-year term, with an option to be reappointed for additional terms. Prospective Panel members may self-nominate at any time. When specific or unique subject matter expertise is required, the co-editors together with working group leaders may solicit advice from individuals with such specialized knowledge. The list of the current Panel members can be found in Appendix C.
Financial disclosure and management of conflicts of interest
All members of the Panel submit a written financial disclosure annually reporting any associations with manufacturers of drugs, vaccines, medical devices, or diagnostics used to manage HIV-related OIs. A list of these disclosures and their last update is available in Appendix C. The co-editors review each reported association for potential conflicts of interest and determine the appropriate action: disqualification from the Panel, disqualification or recusal from topic review and discussion, or no disqualification needed. A conflict of interest is defined as any direct financial interest related to a product addressed in the section of the guideline to which a Panel member contributes content. Financial interests include direct receipt by the Panel member of payments, gratuities, consultancies, honoraria, employment, grants, support for travel or accommodation, or gifts from an entity having a commercial interest in that product. Financial interests also include direct compensation for membership on an advisory board, data safety monitoring board, or speakers’ bureau. Compensation and support provided to a Panel member’s university or institution (e.g., grants, research funding) is not considered a conflict of interest. The co-editors strive to ensure that 50% or more of the members of each working group have no conflicts of interest.
Users of the guidelines
HIV treatment providers
Developer
Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents—a working group of the Office of AIDS Research Advisory Council (OARAC).
Funding source
The Office of AIDS Research (OAR), 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 information prepared by the U.S. Food and Drug Administration or manufacturers (e.g., warnings to the public) may be used as evidence to revise the guidelines. Panel members of each working group are responsible for identifying relevant literature, conducting a systematic comprehensive review of that literature, and proposing updates to the guidelines based on the literature review.
Method of synthesizing data and formulating recommendations
Each section of the guidelines is assigned to a working group of Panel members with expertise in the area of interest. The members of the working group synthesize the available data. Recommendations are reviewed and updated by each working group after an assessment of the quality and impact of the existing and any new data. Aspects of evidence that are considered include but are not necessarily limited to the type of study (e.g., case series, prospective cohort, randomized controlled trial), the quality and appropriateness of the methods, and the number of participants and effect sizes observed. Finally, all proposed recommendations and supporting evidence are reviewed by the co-editors, OAR, subject matter experts at CDC and HIVMA/IDSA before final approval and publication.
Recommendation rating
Recommendations are rated according to the information in the table below, “Rating System for Prevention and Treatment Recommendations,” and accompanied, as needed, by explanatory text that reviews the evidence and the working group’s assessment. All proposed changes are discussed during teleconferences and by email and then assessed by the Panel’s co-editors and reviewed by OAR, CDC, and IDSA before being endorsed as official recommendations.
Other guidelines
These guidelines focus on prevention and treatment of HIV-related OIs for adults and adolescents. A separate guideline outlines similar recommendations for children who have HIV infection. These guidelines are also available on the AIDSinfo website (https://aidsinfo.nih.gov). 
Update plan
Each working group leader and the co-editors meet every 3 months by teleconference to review interim data that may warrant modification of the guidelines. Updates may be prompted by approvals of new drugs, vaccines, medical devices or diagnostics, by new information regarding indications or dosing, by new safety or efficacy data, or by other information that may affect prevention and treatment of HIV-related OIs. In the event of new data of clinical importance, the Panel may post an interim announcement on the AIDSinfo website (https://aidsinfo.nih.gov) pending update of the guidelines with the appropriate changes.
Public comments
A 2-week public comment period follows release of a guidelines update on the AIDSinfo website. Comments received are reviewed by the appropriate work group(s) and the co-editors determine whether revisions to the guidelines are indicated. The public may also submit comments to the Panel at any time at contactus@aidsinfo.nih.gov.

Rating System for Prevention and Treatment Recommendations
Strength of Recommendation
Quality of Evidence for the 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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