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  • There is no difference in risk for adverse birth outcomes between three antiretroviral drug regimens taken by pregnant women with HIV.
  • The antiretroviral drugs studied were TDF-FTC-ATV/r, TDF-FTC-LPV/r, and ZDV-3TC-LPV/r
  • However, due to data from a previous study which indicated that use of TDF-FTC-LPV/r results in adverse birth outcomes, the use of this drug continues to be limited.

The risk of adverse birth outcomes including preterm birth and early infant death was found to be similar for three antiretroviral drugs taken by pregnant women with HIV. The study was conducted by a research team from Harvard T.H. Chan School of Public Health and is published in the New England Journal of Medicine.

Three-drug Anti-retroviral Therapy

Antiretroviral therapy (ART) consists of the combination of antiretroviral drugs to maximally suppress the HIV virus and stop disease progression. Use of three or more antiretroviral drugs is often referred to as an anti-HIV 'cocktail' and is more effective at treating HIV than a single drug.
Adverse Birth Outcomes from Three Antiretroviral Regimens Similar

The wide use of three-drug antiretroviral therapy (ART) by pregnant women with HIV has significantly reduced the risk of HIV transmission from mother-to-child to less than 1%. However, an earlier trial called the PROMISE trial had raised concerns about the safety of one of the antiretroviral drug regimen called TDF-FTC-LPV/r.


The trial found that women in sub-Saharan Africa and India who took TDF-FTC-LPV/r (tenofovir disoproxil fumarate, emtricitabine, and ritonavir-boosted lopinavir) were at greater risk for giving birth to premature babies and early infant death (within 14 days after delivery) than those taking ZDV-3TC-LPV/r (zidovudine, lamivudine, and ritonavir-boosted lopinavir).

Study Overview

The WHO recommends a once-daily TDF-FTC-based regimen as first-line therapy for all HIV-infected adults, including pregnant women. This study set out to compare the risks posed by the two regimens studied in the PROMISE trial and an additional regimen using TDF-FTC and a different protease inhibitor called ATV/r (ritonavir-boosted atazanavir).

The study analyzed data of 1,621 mothers from two U.S.-based studies who had started taking one of the three drug combinations before or during pregnancy.

Study Findings

All three regimens studied were found to pose similar risks for adverse birth outcomes.
  • Women using TDF-FTC-ATV/r had lower risks of preterm birth and low birth weight than those using TDF--FTC-LPV/r, and a similar or lower risk than those using ZDV-3TC-LPV/r.
  • TDF-FTC-LPV/r was found to be rarely used in the US, which may have limited the statistical accuracy of the study to identify risks associated with this combination.
"It was reassuring to see that the use of TDF-FTC-ATV/r during pregnancy was not associated with an increased risk of poor birth outcomes in our study," said first author Kathryn Rough, "But based on the earlier results from the PROMISE trial, it may be wise to continue limiting the use of TDF-FTC-LPV/r in pregnant women with HIV."

References :
  1. Birth Outcomes for Pregnant Women with HIV Using Tenofovir-Emtricitabine - (
Source: Medindia

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