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

April 25, 2018

Key takeaways:
  • There was no difference in risk for adverse birth outcomes, including premature delivery and death of the newborn baby between three antiretroviral drug regimens taken by pregnant women with HIV: TDF-FTC-ATV/r, TDF-FTC-LPV/r, and ZDV-3TC-LPV/r

  • Researchers recommend that use of TDF-FTC-LPV/r in pregnant women with HIV continue to be limited due to risks found by a previous study.


Boston, MA - 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 pregnant women 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 birth (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 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. 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 women with HIV."
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Other Harvard Chan researchers include George Seage, Paige Williams, Sonia Hernandez-Diaz, Yanling Huo, David Shapiro, and Kunjal Patel, the paper's senior author.

The Pediatric HIV/AIDS Cohort Study (PHACS) was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) with co-funding from the National Institute on Drug Abuse, the National Institute of Allergy and Infectious Diseases (NIAID), the Office of AIDS Research, the National Institute of Mental Health (NIMH), the National Institute of Neurological Disorders and Stroke, the National Institute on Deafness and Other Communication Disorders, the National Heart, Lung, and Blood Institute, the National Institute of Dental and Craniofacial Research, and the National Institute on Alcohol Abuse and Alcoholism, through cooperative agreements with the Harvard T.H. Chan School of Public Health (HD052102) and the Tulane University School of Medicine (HD052104). Support for the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network was provided by the NIAID of the National Institutes of Health (NIH) under award numbers UM1AI068632 (IMPAACT LOC), UM1AI068616 (IMPAACT SDMC), and UM1AI106716 (IMPAACT LC), with cofunding from the NICHD and the NIMH. Rough was additionally supported by grant number T32 AI007433 from the NIAID.

"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

Visit the Harvard Chan School website for the latest news, press releases, and multimedia offerings.

Harvard T.H. Chan School of Public Health brings together dedicated experts from many disciplines to educate new generations of global health leaders and produce powerful ideas that improve the lives and health of people everywhere. As a community of leading scientists, educators, and students, we work together to take innovative ideas from the laboratory to people's lives--not only making scientific breakthroughs, but also working to change individual behaviors, public policies, and health care practices. Each year, more than 400 faculty members at Harvard Chan School teach 1,000-plus full-time students from around the world and train thousands more through online and executive education courses. Founded in 1913 as the Harvard-MIT School of Health Officers, the School is recognized as America's oldest professional training program in public health.

Harvard T.H. Chan School of Public Health

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