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 - September 14, 2011
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Clinical Practice Guideline Watch
Updated Guidelines for Perinatal Antiretroviral Use
The revision includes several new clinical recommendations, as well as a provocative discussion on when to start antiretrovirals in pregnant women who do not require treatment for their own health.
On September 14, 2011, the U.S. Department of Health and Human Services released an updated version of its guidelines for perinatal antiretroviral use. The most important changes in clinical recommendations are as follows:
- Tenofovir is now considered an "alternative" nucleoside reverse transcriptase inhibitor (NRTI) choice during pregnancy, instead of being limited to "use in special circumstances." This shift likely reflects current practice patterns, as well as Antiretroviral Pregnancy Registry data showing no excess risk for birth defects among 1092 infants exposed to tenofovir during the first trimester. However, concerns about the drug remain because of animal studies showing decreased fetal growth and reductions in fetal bone porosity.
- Lopinavir/ritonavir (twice daily) remains the "preferred" protease inhibitor during pregnancy, but the guidelines now call for an increased dose during the second and third trimesters — to 600 mg of lopinavir and 150 mg of ritonavir, each twice daily.
- The guidelines now recommend combination antiretroviral therapy for all pregnant women with HIV/hepatitis B virus (HBV) coinfection. The NRTI backbone in these regimens should consist of two drugs that are active against HBV; the preferred pairing is tenofovir with either FTC or 3TC.
- Single-dose nevirapine during labor is no longer recommended for HIV-infected women who did not receive antiretrovirals during pregnancy. Instead, intravenous AZT should be given during labor, and combination antiretroviral prophylaxis should be administered to the infant for 6 weeks.
- Consistent with recent label changes for lopinavir/r, the panel recommends that lopinavir/r not be administered to neonates before a postnatal age of 14 days and a postmenstrual age (based on the first day of the mother's last menstrual period) of 42 weeks.
Comment: Compared with previous updates of the same guidelines, this update provides more-substantive tables and discussions (e.g., on reproductive options for HIV-seroconcordant and HIV-serodiscordant couples, in light of recent results from pre-exposure prophylaxis trials and HPTN 052). The new sections on diagnosing and managing HIV-2 infection and acute HIV-1 infection during pregnancy are particularly helpful. Perhaps the most provocative addition is a discussion on the timing of ART initiation in antiretroviral-naive HIV-infected pregnant women who do not require treatment for their own health. Although the guidelines state that clinicians can still consider deferring antiretrovirals until the second trimester in such women, they now note that "earlier initiation of therapy may be more effective in reducing in utero transmission." The data cited to support this statement are from a recent case-control study involving 19 cases of vertical HIV transmission that occurred despite maternal viral loads <500 copies/mL at delivery (JW AIDS Clin Care Feb 12 2010). However, the authors of that study concluded that the optimal time to initiate ART during pregnancy remains undefined. Until further data emerge, the decision on whether to initiate antiretrovirals during the first trimester or afterward is best made on a case-by-case basis in discussion with the patient.
— Sally Hodder, MD
Dr. Hodder is Professor of Medicine, Vice Chair of the Department of Medicine, and Director of the Adult HIV/AIDS Program at the University of Medicine and Dentistry of New Jersey. She serves as a consultant for Janssen Therapeutics, Gilead Sciences, and Merck. She also reports receiving current research support from Janssen Therapeutics, Gilead Sciences, and GlaxoSmithKline.
Published in Journal Watch HIV/AIDS Clinical Care October 24, 2011
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Eddie A. Angles Y.
Medico Infectologo / Tropicalista
Medico Infectologo / Tropicalista
Hospital Nacional Arzobispo Loayza (HNAL)
Grupo de Investigacion Peruano de Enfermedades Infecciosas y Tropicales (GIPEIT)
Cel. 511-996470205 www.gipeit.org
Cel. 511-996470205 www.gipeit.org
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