HIV Studies Lack Insight on Pregnant Patients

HIV-positive women are frequently being excluded from research, and bioethicist Anne Lyerly is calling attention to the urgent need for effective HIV prevention and treatment in pregnant women worldwide.

Although there have been studies conducted on HIV-positive pregnant women, most of the outcomes focus entirely on the health of the fetus, and many studies exclude pregnant women altogether, including preventive studies. In a study published in AIDS, researchers interviewed 62 HIV clinicians and investigators to determine what HIV experts and researchers perceived to be the barriers in conducting research with pregnant women.

“(This lack of research has resulted in) major gaps in understanding how best to address the health needs of pregnant women living with or at risk for HIV,” Lyerly said. “(And) led to a dearth of evidence to guide safe and effective treatment and prevention of HIV in pregnancy.”

To help bridge this gap, Lyerly leads the PHASES Project, a multi-institutional grant of more than $3 million from the National Institutes of Health (NIH) to develop guidance for ethically advancing HIV research in pregnant women.

Although many of the clinicians and investigators involved in the study were from the United States, nearly half of those researchers conducted their studies international — primarily in Sub-Saharan Africa.

“Investigators face numerous challenges to conducting needed HIV research with pregnant women,” Lyerly said. “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.”

One reason there is a lack of research on pregnant women is the complex ethical concerns that, in part, stem from a catch-22 dilemma: “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,” Lyerly said.

Additionally, there are legal concerns with many investigators, who find it difficult to interpret federal rules for research that involves pregnant women. This only adds to the difficulty of conducting research.

Furthermore, some investigators reported that these types of studies were often more cost-prohibitive, in terms of research and as potential associated care.

“The long list of challenges may seem discouraging, but there is good news,” Lyerly said. “Our consultations suggest that evidence gaps for the HIV response in pregnancy are due neither to lack of will among investigators nor their failure to recognize the research and clinical needs of pregnant women. Rather, these gaps are largely a function of questions, disincentives, and barriers in the wider research environment, many of which we can and need to navigate in order to fairly address the health needs of pregnant women living with or at risk for HIV and their children. While these challenges are significant, they are not insurmountable.”