Risks to babies of mothers with HIV from three antiretroviral regimens appear to be low

April 25, 2018, Harvard T.H. Chan School of Public Health
HIV infecting a human cell. Credit: NIH

The risk for preterm birth and early infant death is similar for three antiretroviral drug regimens taken by pregnant women with HIV according to a new study from Harvard T.H. Chan School of Public Health.

The study will be published in the April 26, 2018 issue of the New England Journal of Medicine.

Global use of three-drug antiretroviral therapy (ART) by with HIV has reduced the risk of mother-to-child transmission of the virus to less than 1%, but an earlier trial, the PROMISE trial, had raised concerns about the safety of one regimen.

In that trial, it was found that women in sub-Saharan Africa and India who took TDF-FTC-LPV/r (tenofovir disoproxil fumarate, emtricitabine, and ritonavir-boosted lopinavir) had infants at greater risk for very premature (less than 34 weeks of gestation) and death within 14 days after delivery than those taking ZDV-3TC-LPV/r (zidovudine, lamivudine, and ritonavir-boosted lopinavir).

Because the World Health Organization recommends a once-daily TDF-FTC-based regimen as first-line therapy for all HIV-infected adults, including pregnant women, the Harvard Chan researchers wanted 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 (drug that prevents viral replication) called ATV/r (ritonavir-boosted atazanavir).

The study analyzed data from 1,621 mothers in two U.S.-based cohort studies—the Surveillance Monitoring for ART Toxicities (SMARTT) study of the Pediatric HIV/AIDS Cohort Study (PHACS) and the P1025 study of the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network—who had started taking one of the three drug combinations before or during pregnancy.

The researchers found that all three regimens pose similar risks for adverse birth outcomes. In addition, women using TDF-FTC-ATV/r had lower risks of and low birth weight than those using TDF—FTC-LPV/r, and a similar or lower risk than those using ZDV-3TC-LPV/r. However, the authors noted that TDF-FTC-LPV/r is rarely used in the United States, 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, who conducted the study as a doctoral student at the School. "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 with HIV."

Explore further: NIH begins large HIV treatment study in pregnant women

More information: "Birth Outcomes for Pregnant Women with HIV Using Tenofovir-Emtricitabine," Kathryn Rough, George R. Seage, III, Paige L. Williams, Sonia Hernandez-Diaz, Yanling Huo, Ellen G. Chadwick, Judith S. Currier, Risa M. Hoffman, Emily Barr, David E. Shapiro, and Kunjal Patel, NEJM, online April 26, 2018, doi: DOI: 10.1056/NEJMoa1701666

Related Stories

NIH begins large HIV treatment study in pregnant women

January 24, 2018
The National Institutes of Health has launched a large international study to compare the safety and efficacy of three antiretroviral treatment regimens for pregnant women living with HIV and the safety of these regimens ...

Study identifies superior drug regimen for preventing mother-to-child HIV transmission

November 18, 2014
For HIV-infected women in good immune health, taking a three-drug regimen during pregnancy prevents mother-to-child HIV transmission more effectively than taking one drug during pregnancy, another during labor and two more ...

Overall risk of birth defects appears low for women taking antiretrovirals during early pregnancy

November 10, 2014
Among pregnant women infected with HIV, the use of antiretroviral (ARV) medications early in pregnancy to treat their HIV or to prevent mother-to-child transmission of HIV does not appear to increase the risk of birth defects ...

Maternal, neonatal adverse events up with antenatal ART

November 3, 2016
(HealthDay)—For HIV-infected pregnant women, antiretroviral therapy (ART) is associated with significantly lower rates of early HIV transmission, but with a higher risk of adverse maternal and neonatal outcomes, according ...

Effective treatments available for HIV patients not eligible for efavirenz regimens

October 6, 2014
A new national clinical trial found HIV drug regimens that do not include efavirenz are effective as first-line antiretroviral therapy. The finding is important for patients who are not eligible for treatment with efavirenz, ...

Antiviral drug not beneficial for reducing mother-to-child transmission of hep B when added to existing preventatives

March 7, 2018
Tenofovir disoproxil fumarate (TDF), an antiviral drug commonly prescribed to treat hepatitis B infection, does not significantly reduce mother-to-child transmission of hepatitis B virus when taken during pregnancy and after ...

Recommended for you

Long-acting injectable implant shows promise for HIV treatment and prevention

October 9, 2018
A persistent challenge in HIV/AIDS treatment and prevention is medication adherence – getting patients to take their medication as required to get the best results.

Scientists develop rapid test for diagnosing tuberculosis in people with HIV

October 8, 2018
An international team that includes Rutgers scientists has made significant progress in developing a urine diagnostic test that can quickly, easily and inexpensively identify tuberculosis infection in people also infected ...

Researchers uncover new role of TIP60 protein in controlling tumour formation

October 8, 2018
Scientists from the Cancer Science Institute of Singapore (CSI Singapore) at the National University of Singapore (NUS) have discovered a new molecular pathway that controls colorectal cancer development, and their exciting ...

Combination therapy targets latent reservoir of HIV

October 3, 2018
With more than 35 million people worldwide living with the virus and nearly 2 million new cases each year, the human immunodeficiency virus (HIV) remains a major global epidemic. Existing antiretroviral drugs do not cure ...

Anti-integrin therapy effect on intestinal immune system in HIV-infected patients

October 3, 2018
In a study published today in Science Translational Medicine, Mount Sinai researchers describe for the first time a mechanism that may shrink collections of immune cells in the gastrointestinal (GI) tract, called lymphoid ...

No 'reservoir': Detectable HIV-1 in treated human liver cells found to be inert

October 1, 2018
In a proof-of-principle study, researchers at Johns Hopkins report that a certain liver immune cell called a macrophage contains only defective or inert HIV-1 copies, and aren't likely to restart infection on their own in ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.