- There is no difference in risk for adverse
birth outcomes between three
antiretroviral drug regimens taken by pregnant women with HIV.
antiretroviral drugs studied were TDF-FTC-ATV/r, TDF-FTC-LPV/r, and
- 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
(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.
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
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
‘The anti-HIV regimen that was found to be linked with poorer birth outcomes in a previous clinical trial was not associated with the adverse birth outcomes in this study.’
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.
All three regimens studied were
found to pose similar risks for adverse birth outcomes.
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
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
"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
- Birth Outcomes for Pregnant Women with HIV Using Tenofovir-Emtricitabine - (https://www.eurekalert.org/emb_releases/2018-04/htcs-rtb042318.php)