Q&A: Treating pregnant women with flu
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A review published recently in Open Forum Infectious Diseases summarized the available clinical evidence on the safety and effectiveness of antiviral treatment for influenza in pregnant women.
For the review, Tim Uyeki MD, MPH, MPP, chief medical officer in the CDC’s Influenza Division, and colleagues analyzed data published between Jan. 1, 1999, and Oct. 10, 2020. We spoke with Uyeki about the review and what it found.
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Healio: What is currently recommended for pregnant and postpartum women?
Uyeki: Women who are pregnant during influenza season are recommended to receive influenza vaccination to protect them and their babies from influenza. Pregnant women and those up to 2 weeks postpartum may be at increased risk for influenza complications. During influenza season, pregnant women and those up to 2 weeks postpartum who develop acute respiratory symptoms should contact their health care provider as soon as symptoms begin to be assessed for possible influenza. If influenza is diagnosed, antiviral treatment with oseltamivir is recommended to be started as soon as possible after symptom onset. The CDC does not recommend antiviral treatment of influenza with baloxavir for pregnant women because of the lack of safety and efficacy data for baloxavir in this population.
Healio: What did your review find?
Uyeki: There have not been any clinical trials of antiviral treatment of influenza conducted among pregnant women, and recommendations for antiviral treatment of pregnant women with influenza are based upon findings of clinical trials in nonpregnant persons and observational studies in different populations. No observational studies were identified on baloxavir treatment of pregnant women with influenza. Multiple observational studies have reported reduction of severe clinical outcomes when pregnant and postpartum women with influenza were treated with oseltamivir or other neuraminidase inhibitor antiviral medications early in their illness. Although studies using animal and human placental models have shown that oseltamivir and its active drug metabolite oseltamivir carboxylate can cross the placenta, studies of pregnant women who received oseltamivir in different countries have not identified any increased risk of adverse maternal, fetal or neonatal outcomes. Modeling studies have suggested that pregnant women may require higher dosing of oseltamivir compared with nonpregnant women because of physiological changes during pregnancy, and therefore, additional studies are needed to determine the optimal dosing of oseltamivir for treatment of influenza during pregnancy.
Overall, given the totality of the available data on effectiveness and safety, oseltamivir is the preferred antiviral medication for treatment of influenza in pregnant women, and ideally, oseltamivir treatment should be started as soon as possible after influenza illness onset.
Healio: What challenges did you encounter when conducting this analysis?
Uyeki: The main challenge was that because no randomized controlled clinical trials of antiviral treatment of influenza have been conducted in pregnant women, we needed to review the findings of available preclinical experimental studies, pharmacokinetic modeling studies and observational studies that addressed different aspects of antiviral treatment of pregnant women with influenza and pregnancy outcomes, and we found that data were very limited for available antiviral drugs, except for oseltamivir.
Healio: Is someone working on safety and efficacy studies on baloxavir marboxil use in pregnant women, and when might data be available?
Uyeki: I am not aware that there are any clinical trials that are studying the safety and efficacy of baloxavir in pregnant women with influenza. There are no clinical trials of baloxavir in pregnant women registered on ClinicalTrials.gov.
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