AEGiS-FDA: Revised Perinatal Guidelines available

Important note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.

Revised Perinatal Guidelines available

Food and Drug Administration - November 6, 2007
Richard Klein & Kimberly Struble

The Public Health Service Task Force Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV-1 Transmission in the United States have undergone a complete revision and reorganization to reflect important new information, and to make them more user-friendly. The guidelines have been restructured into principles for medical management of the woman and her infant during the antepartum, intrapartum, and postpartum period, including panel recommendations for each section.

Changes to the report include the following:

• Due to contamination with ethyl methane sulfonate (EMS), nelfinavir is no longer recommended for use in pregnant HIV-infected women

• New sections on antepartum management of HIV-infected pregnant women in special situations, including HBV and HCV coinfection

• New information on ARV drug choice and continuation during labor, and management of women not receiving antepartum ARVs

• New sections on choice and management of infant ARV prophylaxis

• Two new tables: "Results of Major Studies on ARV Prophylaxis to Prevent Mother-to-Child HIV Transmission" and "Clinical Scenario Summary Recommendations for ARV Use by Pregnant HIV-Infected Women and Prevention of Perinatal HIV-1Transmission in the U.S."

• Updated information for emtricitabine, tenofovir, amprenavir, atazanavir, lopinavir/ritonavir, nelfinavir, maraviroc, and raltegravir in Table 2, "Preclinical & Clinical Data Relevant to the Use of ARVs in Pregnancy"

• Updated information for tenofovir, saquinavir-HGC, atazanavir, nelfinavir, maraviroc, and raltegravir in Table 3, "ARV Use in Pregnant HIV-Infected Women: Pharmacokinetic and Toxicity Data in Human Pregnancy and Recommendations for Use in Pregnancy"

The updated guidelines are available in the "Guidelines" section of the AIDSinfo Web site under " Perinatal Guidelines." You can download the guidelines or can request to receive them by e-mail or regular mail on the AIDSinfo Web site.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

071106
FD071104

SOURCE: Food and Drug Administration (FDA).

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