New ART Recommendations for Pregnant Women With HIV

Pregnant woman holding medication
Pregnant woman holding medication
The GRADE framework recommendations provide guidance for combination treatment regimens based on 2 systemic reviews, patient considerations, fetal outcomes, and practical issues.

A panel of specialists, women living with HIV, generalists, and methodologists issued the recommendation that pregnant women with HIV should be treated with zidovudine (AZT) and lamivudine over tenofovir or emtricitabine in combination with other antiretrovirals. The recommendation was published in BMJ.1

The recommendation was informed by 2 systematic reviews that evaluated the benefits and harms of nucleoside reverse transcriptase inhibitor regimens for pregnant women, as well as the values and preferences of women considering antiretroviral therapy.2,3

The first systematic review, which evaluated the benefits and harms of antiretroviral therapy in pregnant women, found that tenofovir/emtricitabine increased the risk for stillbirths and early neonatal deaths, as well as premature delivery.2 

The majority of this evidence came from the PROMISE trial, which compared tenofovir/emtricitabine with AZT/lamivudine in pregnant women also receiving lopinavir/ritonavir.

On the basis of this systematic review, the guideline panel judged the evidence quality for the detrimental neonatal effects of tenofovir/emtricitabine to be of moderate certainty. The certainty level is moderate because of the potential for an unknown confounder in the PROMISE study, as well as the potential for the specific combination of tenofovir/emtricitabine with lopinavir/ritonavir to have caused the noted adverse effects.

Because tenofovir/emtricitabine is delivered in a coformulated once-daily pill, the guideline panel also requested a systematic review to determine the treatment preferences of women living with HIV. Evidence from the resultant review indicated that women prioritize their own health and their child’s health, should they become pregnant. Women place a lower value on pill burden or medication complexity.3

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On the basis of the results of the systematic reviews, the guideline panel concluded with low to moderate certainty that AZT and lamivudine would be preferred to emtricitabine and tenofovir in pregnant women. However, for women with active hepatitis B and a high risk for vertical hepatitis B transmission, tenofovir/emtricitabine may be preferred.1

Reed Siemieniuk, MD, lead author of the rapid recommendation, concluded that although the World Health Organization continues to recommend tenofovir and emtricitabine as part of first-line therapy for pregnant women, “most women who are pregnant or who may become pregnant are likely to find the associated risks unacceptable and prefer AZT/lamivudine.”


  1. Siemieniuk RAC, Lytvyn L, Mah Ming J, et al. Antiretroviral therapy in pregnant women living with HIV: a clinical practice guideline. BMJ. 2017;358:j3961.
  2. Siemieniuk RA, Foroutan F, Mirza R, et al. Antiretroviral therapy for pregnant women living with HIV or hepatitis B: a systematic review and meta-analysis. BMJ Open. 2017;7(9):e019022.
  3. Lytvyn L, Siemieniuk RA, Dilmitis S, et al. Values and preferences of women living with HIV who are pregnant, postpartum or considering pregnancy on choice of antiretroviral therapy during pregnancy. BMJ Open. 2017;7(9):e019023.