Major Gaps in HIV Research Leave Pregnant Women at Risk

About 8,500 women with the human immunodeficiency virus (HIV) give birth every year, according to the Centers for Disease Control and Prevention (CDC). Although prenatal transmission has declined by 90% since the early 1990s, the need for studies focusing are pregnant women with HIV are very much needed.

Research involving HIV in pregnant women typically looks at the fetus and not the actual woman, explained a statement from the University of North Carolina School of Medicine.

Lead author Anne Lyerly, MD, MA, an obstetrician/gynecologist and associate director of the UNC Center for Bioethics, said, “limited safety data on HIV-related drugs in pregnancy sparks concerns about unknown potential maternal-fetal exposure risks, which leads to reluctance to study pregnant women, in turn perpetuating the lack of safety data that could inform next steps for research.”

This is where the PHASES Project comes in. Led by Lyerly, the initiative was provided by the National Institutes of Health in the form of over $3 million. The grant was given to multiple institutions in order to create a guidance to drive HIV research in pregnant women.

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The UNC team had one-on-one conversations with 62 HIV clinicians and researchers in order to gather their experiences and thoughts about how research is done in HIV-infected pregnant women. Almost half of the cohort had done research in Sub-Saharan Africa, however, there were US-based researchers as well.

“Advancing such research will require guidance regarding ethical and legal uncertainties, incentives that encourage rather than discourage investigators to undertake such research; and a commitment to earlier development of safety and efficacy data through creative trial designs,” said Lyerly, who is also an associate professor of social medicine at UNC School of Medicine.

The experts agreed that research is needed on safe, effective dosing for newer antiretroviral drugs, coinfection treatments, and emerging preventive methods. Physicians also struggle with weighing the risks and benefits of treatment in this population, and legal and liability issues that could follow.

Based off of the results published in the journal AIDS, the researchers said that the research gap for HIV in pregnant women doesn’t appear to be due to investigators’ lack of wanting to do it or failing to recognize that it’s needed. These gaps seem to be a matter of questions and challenges.

“With these challenges are significant, they are not insurmountable,” Lyerly concluded.

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