New Guideline for Perinatal HIV Management Elicits Controversy

October 4, 2017

New Guideline for Perinatal HIV Management Elicits Controversy

  1. Andrea L. Ciaranello, MD, MPH and
  2. Rajesh T. Gandhi, MD

This recommendation calls for a return to AZT/3TC-based regimens in pregnant women; other expert panels strongly disagree.

  1. Andrea L. Ciaranello, MD, MPH and
  2. Rajesh T. Gandhi, MD

Sponsoring Organization: The MAGIC Project

Target Audience: Clinicians caring for pregnant women with HIV

Background and Objective

Guidelines from the WHO, British HIV Association (BHIVA), and U.S. Department of Health and Human Services (DHHS) recommend tenofovir disoproxil fumarate (TDF) as one component of antiretroviral therapy (ART) for pregnant women with HIV. Now, a panel of healthcare providers, researchers, and patient representatives has issued new recommendations regarding ART in pregnancy.

The panel considered results from the PROMISE trial (NEJM JW Infect Dis Dec 2016 and N Engl J Med 2016; 375:1726), in which lopinavir/ritonavir (LPV/r)–based ART (with TDF/FTC or AZT/3TC) was compared with AZT alone in pregnant women with HIV and high CD4 cell counts. Unexpectedly higher rates of early neonatal death and very preterm delivery were observed in infants of women randomized to TDF/FTC plus LPV/r versus AZT/3TC plus LPV/r.

Key Recommendation

Based largely on this trial, the panel advocates an AZT/3TC-based regimen over one containing TDF/FTC for pregnant women with HIV. The recommendation is strong when these drugs are used with LPV/r and weak when they are used with other medications.


This recommendation has elicited substantial controversy, with guidelines committees (e.g., BHIVA) and the PROMISE study team formally disagreeing. The PROMISE findings may have been related in part to study design (comparisons between TDF- and AZT-based combination ART were available only for a subset of participants) or to drug interactions between TDF and the relatively high doses of LPV/r used.

Major guidelines no longer recommend LPV/r during pregnancy, making the findings less relevant to the current care of pregnant women with HIV. In addition, other systematic reviews and large observational studies have shown no increased risk for adverse pregnancy outcomes with TDF-based compared with AZT-based ART. Finally, AZT-based ART is less well tolerated than TDF-containing regimens and therefore is no longer recommended for nonpregnant adults. In our practice, we continue to use TDF-based regimens for pregnant women with HIV.

Dr. Ciaranello is Assistant Professor of Medicine at Harvard Medical School, Director of the Perinatal Infectious Diseases Program at Massachusetts General Hospital, member of the DHHS Panel on Treatment of Pregnant Women Living with HIV and Prevention of Perinatal Transmission, and leader of the PROMISE cost-effectiveness substudy. She has no competing financial interests.

Editor Disclosures at Time of Publication

  • Disclosures for Rajesh T. Gandhi, MD at time of publication Grant / Research support Gilead; Merck; ViiV Editorial Boards UpToDate Leadership positions in professional societies Department of Health and Human Services, Antiretroviral Guidelines for Adults and Adolescents (Scientific Member); HIV Medical Association (Board Member); ID Week (Program Committee); International Antiviral Society-USA (Guidelines Committee)


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