Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States

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: December 7, 2018; Last Reviewed: December 7, 2018

Table 1. Outline of the Guidelines Development Process
Topic Comment
Goal of the Guidelines Provide guidance to HIV care practitioners in the United States on the optimal use of antiretroviral (ARV) agents in pregnant women who are living with HIV for treatment of HIV infection and for prevention of perinatal transmission of HIV, as well as management of HIV-exposed infants.
Panel Members The Panel is composed of approximately 30 voting members who have expertise in managing the care of pregnant women living with HIV (e.g., training in obstetrics/gynecology, infectious diseases, or women’s health), pharmacology of ARV drugs during pregnancy, and interventions for prevention of perinatal transmission (e.g., specialized training in pediatric HIV infection), as well as community representatives with knowledge of HIV infection in pregnant women and interventions for prevention of perinatal transmission. The U.S. government representatives, appointed by their agencies, include at least one representative from each of the following Department of Health and Human Services agencies: the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Health Resources and Services Administration, 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 re-appointment. The Panel may also include liaison members from the Perinatal HIV Hotline, the American Academy of Pediatrics’ Committee on Pediatric AIDS, and the American College of Obstetricians and Gynecologists. A list of all Panel members can be found in the Guidelines Panel Members section.
Financial Disclosures All members of the Panel submit an annual written financial disclosure that reports any association with manufacturers of ARV drugs or diagnostics used for management of HIV infections. See Financial Disclosure for a list of the latest disclosures.
Users of the Guidelines Providers of care to pregnant women who are living with HIV and to infants who have been exposed to HIV
Developer The Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission—a working group of the Office of AIDS Research Advisory Council (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 that was 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 a technical assistance consultant 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 all proposals during monthly teleconferences. Proposals are modified based on Panel discussions 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 (via 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 pregnant women living with HIV and their infants. Other guidelines (all of which are available on the AIDSinfo website) outline the use of ARV agents in nonpregnant adults and adolescents with HIV; use of ARV agents in infants and children with HIV; treatment and prevention of opportunistic infections (OIs) in adults and adolescents with HIV, including pregnant women; treatment and prevention of OIs in children who have been exposed to HIV or who have HIV infection; and treatment of people who experience occupational or nonoccupational exposure to HIV. Preconception management for nonpregnant women of reproductive age is briefly discussed in this document. However, for a more detailed discussion of the issues surrounding the treatment of nonpregnant adults, the Working Group defers to the designated expertise offered by the Panels that have developed those guidelines.
Update Plan The Panel meets monthly by teleconference to review data that may require modification of the guidelines. Updates may be prompted by new drug approvals (or new indications, new dosing formulations, and/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.
Public Comments A 2-week public comment period follows 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.

Basis for Recommendations

The recommendations in these guidelines are based on scientific evidence and expert opinion. Each recommended statement is rated with a letter of A, B, or C that represents the strength of the recommendation and with a numeral I, II, or III that represents the quality of evidence.

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, nonrandomized trials or observational cohort studies with long-term clinical outcomes

III: Expert opinion

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