Are Pregnant Women Getting the Right HIV Antiretrovirals?

Pregnant women living with HIV in the United States have a wealth of options for antiretroviral therapy (ART), with new treatments introduced regularly. Yet often the regimens that providers prescribe for their expectant patients are not what the US Department of Health and Human Services (HHS) considers optimal for pregnant women, a new study out of the Harvard T.H. Chan School of Public Health reveals. The research was published in JAMA Network Open.

For more than 25 years, the HHS has published perinatal HIV treatment guidelines considered the gold standard for clinicians. The guidelines have evolved over the years as new therapies have emerged or as negative effects of existing therapies have come to light. Individual and combination ART therapies now are classified as “preferred,” “alternative,” special circumstances,” “lacking sufficient evidence,” and “not recommended for use in pregnancy.”

The investigators examined the results of 1867 pregnancies in 1582 women enrolled in the Pediatric HIV/AIDS Cohort Study Surveillance Monitoring of ART (SMARTT) study between 2008 and 2017. Slightly fewer than half of the pregnancies (49.5%) involved ART classified as preferred or alternative. Slightly more than one quarter (26.4%) of the pregnancies were treated with ART categorized as having insufficient evidence for use during pregnancy. One hundred and thirty-six pregnancies, or 7.3%, involved ART not recommended for use during pregnancy, per the HHS guidelines.

There appeared to be solid reasoning behind the choice of some of the ART regimens. “For women who are already on a fully suppressive ARV [antiretroviral] regimen at the time of conception, the guidelines are clear that even if the regimen is not a preferred or alternative regimen, it should be continued,” Kathleen Powis, MD, MBA, MPH, a researcher at the Harvard T.H. Chan School of Public Health and co-author of the study, told Contagion®. “The only exceptions to this recommendation involve the use of didanosine, stavudine, and full-dose ritonavir, and—in past guidelines—efavirenz, given concern about potential teratogenicity.” For women who in the past had been on ART and wanted to restart it due to pregnancy, drug resistance or negative side effects in previous ART regimens may have been taken into account, prompting prescription of regimens that the guidelines did not endorse, she added.

The study showed that among women who had previously used ART, those who had comparatively high viral levels (greater than 1000 copies/mL) early in pregnancy were more than twice as likely as their more virally suppressed counterparts to be prescribed a guideline-approved ART regimen. “For women with a low viral load, indicating there was minimal or no disease progression while off treatment, clinicians and the women may have felt equally comfortable with resuming the prior treatment regimen, even though at the time ARVs were restarted [they] may not have been...preferred or alternative regimen[s],” Poway said. “This approach is a guidelines-acceptable practice.”

However, in roughly 20% of the pregnancies in the study, women who had never taken ART before were prescribed regimens that were not recommended for use in pregnancy or had insufficient data for use in pregnancy. The reason for this is unclear and warrants further study, according to Powis.

She stressed that it’s important to both raise clinician awareness of the HHS guidelines so informed prescribing choices can be made and to cast a wider research net so pregnant women are included in studies in a more timely manner. Research on the effects of antiretrovirals in pregnancy typically lags behind other antiretroviral research, which could result in prescribing practices that don’t reflect the newest generation of medications, she indicated.