(Last updated: August 6, 2015; last reviewed: August 6, 2015)
Recommendations regarding HIV screening and treatment of pregnant women and prophylaxis for perinatal transmission of HIV have evolved considerably in the United States since the mid-1990s, reflecting changes in the epidemic and the science of prevention and treatment. With the implementation of recommendations for universal prenatal HIV counseling and testing, antiretroviral (ARV) prophylaxis, scheduled cesarean delivery, and avoidance of breastfeeding, the rate of perinatal transmission of HIV has dramatically diminished to 2% or less in the United States and Europe.1,2 In response to this success, the Centers for Disease Control and Prevention has developed a goal of eliminating perinatal HIV transmission in the United States, defined as reducing perinatal transmission to an incidence <1 infection per 100,000 live births and to a rate of <1% among HIV-exposed infants.3
The annual number of pregnancies among HIV-infected women in the United States appears to be increasing, as routine use of antiretroviral therapy (ART) results in HIV-infected women living longer, healthier lives.4 A focus on appropriate overall medical care for HIV-infected women is the best way to prevent HIV infection of infants, including comprehensive reproductive health, family planning and preconception care services, optimization of HIV treatment, and maintenance of care for HIV-infected women between pregnancies. A critical component of prevention of perinatal HIV transmission is ensuring the use of ART to maximally suppress viral replication as early as possible during pregnancy, as discussed in these guidelines.
These guidelines update the March 28, 2014 Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. The Department of Health and Human Services Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission (the Panel), a working group of the Office of AIDS Research Advisory Council (OARAC), develops these guidelines. The guidelines provide health care providers with information for discussion with HIV-infected pregnant women to enable the patient/provider team to make informed decisions regarding the use of ARV drugs during pregnancy and use of scheduled cesarean delivery to reduce perinatal transmission of HIV. The recommendations in the guidelines are accompanied by discussion of various circumstances that commonly occur in clinical practice and the factors that influence treatment considerations. The Panel recognizes that strategies to prevent perinatal transmission and concepts related to management of HIV in pregnant women are rapidly evolving and will consider new evidence and adjust recommendations accordingly. The updated guidelines are available from the AIDSinfo website (http://aidsinfo.nih.gov).
The current guidelines have been structured to reflect the management of an individual mother-child pair and are organized into a brief discussion of preconception care followed by principles for management of a woman and her infant during the antepartum, intrapartum, and postpartum periods. Although perinatal transmission of HIV occurs worldwide, these recommendations have been developed for use in the United States. Alternative strategies may be appropriate in other countries.
|Goal of the Guidelines||Provide guidance to HIV care practitioners on the optimal use of ARV agents in pregnant women for treatment of HIV infection and for prevention of perinatal transmission of HIV and management of HIV-exposed infants 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 obstetrics/gynecology, infectious diseases, or women’s health) and interventions for prevention of perinatal transmission (such as 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 1 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 (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 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 on Page IV of the guidelines.|
|Financial Disclosures||All members of the Panel submit a written financial disclosure annually reporting any association with manufacturers of ARV antiretroviral 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 a representative from 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 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 (via email or teleconference) for additional review, discussion and further modification to reach a final version 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 HIV-infected pregnant women and their infants. Other guidelines (all available on the AIDSinfo website http://www.aidsinfo.nih.gov) outline the use of ARV agents in non-pregnant HIV-infected adults and adolescents; use of ARV agents in HIV-infected infants and children; treatment and prevention of opportunistic infections in HIV-infected adults and adolescents, including pregnant women; treatment and prevention of opportunistic infections in HIV-infected and HIV-exposed children; and treatment of people who experience occupational or non-occupational exposure to HIV.). 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 on the AIDSinfo website (http://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 email@example.com.|
|Key to Acronyms: ARV = antiretroviral; FDA = Food and Drug Administration; HRSA = Health Resources and Services Administration; NIH = National Institutes of Health; OARAC = Office of AIDS Research Advisory Council|
Basis for Recommendations
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, according to the quality of evidence.
|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