Skip Nav

Clinical Guidelines Portal

Home > Guidelines > Perinatal Guidelines > Guidelines Development Process
Text Size

Updated Perinatal Guideline

Updates were made to the Perinatal Guideline on January 22, 2013 and January 29, 2012. For an explanation of the updates, please see the correction notice.

Search Search Help

Guideline Search

Type your search term(s) in the text box. Users can only search one guideline at a time. To search for an exact phrase, use quotation marks (i.e. "what to start"). To narrow your search, add additional relevant terms. If you are not finding what you need, try searching similar terms (i.e. perinatal OR pregnancy) to broaden your search.Close

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

Introduction

Guidelines Development Process

(Last updated:7/31/2012; last reviewed:7/31/2012)

Printer-Friendly Files

Table 1.  Outline of the Guidelines Development Process
Click here to view this table as an image

 Topic

 Comment
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.

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.

Table 2.  Rating Scheme for Recommendations
Click here to view this table as an image

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

References

  1. Centers for Disease Control and Prevention. Achievements in public health. Reduction in perinatal transmission of HIV infection--United States, 1985-2005. MMWR Morb Mortal Wkly Rep. Jun 2 2006;55(21):592-597. Available at http://www.ncbi.nlm.nih.gov/pubmed/16741495.
  2. Jamieson DJ, Clark J, Kourtis AP, et al. Recommendations for human immunodeficiency virus screening, prophylaxis, and treatment for pregnant women in the United States. Am J Obstet Gynecol. Sep 2007;197(3 Suppl):S26-32. Available at http://www.ncbi.nlm.nih.gov/pubmed/17825647.
  3. Birkhead GS, Pulver WP, Warren BL, Hackel S, Rodriguez D, Smith L. Acquiring human immunodeficiency virus during pregnancy and mother-to-child transmission in New York: 2002-2006. Obstet Gynecol. Jun 2010;115(6):1247-1255. Available at http://www.ncbi.nlm.nih.gov/pubmed/20502297.
  4. Cooper ER, Charurat M, Mofenson L, et al. Combination antiretroviral strategies for the treatment of pregnant HIV-1-infected women and prevention of perinatal HIV-1 transmission. J Acquir Immune Defic Syndr. Apr 15 2002;29(5):484-494. Available at http://www.ncbi.nlm.nih.gov/pubmed/11981365.
  5. Townsend CL, Cortina-Borja M, Peckham CS, de Ruiter A, Lyall H, Tookey PA. Low rates of mother-to-child transmission of HIV following effective pregnancy interventions in the United Kingdom and Ireland, 2000-2006. AIDS. May 11 2008;22(8):973-981. Available at http://www.ncbi.nlm.nih.gov/pubmed/18453857.
  6. Birkhead GS, Pulver WP, Warren BL, et al. Progress in prevention of mother-to-child transmission of HIV in New York State: 1988-2008. J Public Health Manag Pract. Nov-Dec 2010;16(6):481-491. Available at http://www.ncbi.nlm.nih.gov/pubmed/20885177.
  7. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/AdultandAdolescentGL.pdf. Accessed June 15, 2012.