Newer ART Regimens Are Linked to Reduced Risk of Negative Pregnancy Outcomes


Women who are pregnant should continue or start treatment with alternative or preferred antiretroviral therapies for viral suppression, investigators suggest.

Newer antiretroviral therapy (ART) regimens have been associated with better pregnancy outcomes than older agents for those with HIV, according to the results of a review published in The New England Journal of Medicine.

3d illustration of HIV virus. Medical concept | Image Credit: artegorov3@gmail -

artegorov3@gmail -

Investigators suggested that women who are pregnant should continue or start treatment with alternative or preferred ART therapies for viral suppression, which outweighs the potential adverse outcomes for infants.

In the review, the investigators aimed to determine which ART regimens had the best safety profiles for use with pregnant women.

The current recommendation for ART therapies during pregnancy includes 2 nucleoside reverse-transcriptase inhibitors in combination with ART from a difference class, according to investigators.

They reported that information on miscarriages, defined as early fetal loss before 20 weeks of gestation, is limited, with many miscarriages going undetected or unreported in clinical settings. This makes it hard for investigators to determine the effect of ART regimens on miscarriage rates in randomized clinical trials.

For stillbirths, defined as late fetal loss at or after 20 weeks gestation, investigators found that taking ART during a pregnancy can reduce the risk, but the risk of stillbirth is still high for individuals receiving ART.

Stillbirth rates are lower for those that transitioned to therapy containing efavirenz (EFV) or dolutegravir in combination with lamivudine or emtricitabine plus tenofovir disoproxil fumarate.

However, investigators noted that the timing of initiation and stillbirth is still undefined and may depend on the regimen that is started.

Additionally, investigators found that HIV treatment during pregnancy can reduce the greater risk of preterm births compared with an individual without HIV.

However, they also said that the reduction could depend on the ART therapy.

They identified that most studies showed an increased risk with ART therapies containing lopinavir and ritonavir.

The effects of the timing of initiation, either before or after conception, is still unclear, they said.

In addition, infants who are exposed but do not acquire HIV are at risk to impaired growth and postnatal neurodevelopment outcomes, investigators said, adding that most studies failed to find a causal link between neurodevelopment outcomes and maternal ART exposure, while maternal EFV-based ART is associated with stunting.

Investigators listed recommendations for future studies, such as standardized definitions of endpoints, including for miscarriage fetal ultrasonography; systemic assessments for congenital anomalies; and unified approaches for gestational diabetes screening.

For enrollment criteria, they noted that careful criteria and analyses could help reduce biases in observational studies of pregnant women.

They also emphasized the importance of randomized safety trials for pregnant women, which they said should be conducted for high-priority regimens that will be used in large numbers by these individuals.

Additionally, increased prenatal surveillance is recommended for adverse pregnancy outcomes, investigators said.

Furthermore, investigators said that the known benefits of ART in pregnant women and have HIV outweigh any potential adverse outcomes for either the infant or the mother.


Eke AC, Mirochnick M, Lockman S. Antiretroviral therapy and adverse pregnancy outcomes in people living with HIV. N Engl J Med. 2023;388(4):344-356. doi:10.1056/NEJMra2212877

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