Topic
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Comment
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Goal of the Guidelines |
Provide guidance to HIV care practitioners on the optimal use of antiretroviral (ARV) agents in pregnant women for treatment of HIV infection and for prevention of mother-to-child transmission (PMTCT) of HIV in the United States. |
Panel Members |
The Panel is composed of approximately 30 voting members who have expertise in management of pregnant HIV-infected women (such as training in either obstetrics/gynecology or women’s health) and interventions for PMTCT (such as specialized training in pediatric HIV infection) as well as community representatives with knowledge of HIV infection in pregnant women and interventions for PMTCT. The U.S. government representatives, appointed by their agencies, include at least 1 representative from each of the following Department of Health and Human Services agencies: the Centers for Disease Control and Prevention, the Food and Drug Administration (FDA), the Health Resources and Services Administration (HRSA), and the National Institutes of Health (NIH). Members who do not represent U.S. government agencies are selected by Panel members after an open announcement to call for nominations. Each member serves on the Panel for a 3-year period, with an option for reappointment. A list of all Panel members can be found in the Panel Roster. |
Financial disclosures |
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). |
Users of the guidelines |
Providers of care to HIV-infected pregnant women and to HIV-exposed infants |
Developer |
Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission—a working group of OARAC |
Funding Source |
Office of AIDS Research, NIH |
Evidence for recommendations |
The recommendations in these guidelines are generally 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 On some occasions, particularly when new information may affect patient safety, unpublished data presented at major conferences or prepared by the FDA and/or manufacturers as warnings to the public may be used as evidence to revise the guidelines.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 |
See 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. A structured literature search is conducted by staff from the HIV/AIDS National Resource Center at the Francois-Xavier Bagnoud Center (through funding from HRSA) and provided to the Panel working group. The members review and synthesize the available data and propose recommendations to the entire Panel. The Panel discusses and votes on all proposals during monthly teleconferences. Proposals receiving endorsement from a consensus of members are included in the guidelines as official Panel recommendations. |
Other Guidelines |
These guidelines focus on HIV-infected pregnant women and their infants. Other guidelines outline the use of ARV agents in non-pregnant HIV-infected adults and adolescents, HIV-infected children, and people who experience occupational or nonoccupational exposure to HIV. The guidelines described are also available on the AIDSinfo website (http://aidsinfo.nih.gov). Preconception management for non-pregnant women of reproductive age is briefly discussed in this document. However, for more detailed discussion on issues of treatment of non-pregnant adults, the Working Group defers to the designated expertise offered by Panels that have developed those guidelines. |
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, new dosing formulations, or changes in dosing frequency), significant new 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 accompanying recommendations on the AIDSinfo website until the guidelines can be updated with appropriate changes. Updated guidelines are available at the AIDSinfo website (http://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. |