April 09, 2021
2 min read
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Uyeki does not report any relevant financial information.
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A review recently published in the Open Forum Infectious Diseases summarized the available clinical evidence of the safety and effectiveness of antiviral treatment for influenza in pregnant women.
For the verification Tim Uyeki MD, MPH, MPP, The CDC’s chief medical officer of the influenza division and his colleagues analyzed the data released between January 1, 1999 and October 10, 2020. We spoke to Uyeki about the review and the results.
A review summarized the available clinical evidence for the safety and effectiveness of antiviral treatment for influenza in pregnant women.
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Healio: What is currently recommended for pregnant and postpartum women?
Stop: Women who are pregnant during the influenza season are recommended to get influenza vaccination to protect them and their babies from influenza. Pregnant women and people up to 2 weeks after giving birth may be at increased risk of influenza complications. During the influenza season, pregnant women and anyone who develops acute respiratory symptoms for up to 2 weeks after giving birth should contact their doctor as soon as symptoms are evaluated for possible influenza. If influenza is diagnosed, it is recommended that antiviral treatment with oseltamivir be started as soon as possible after symptoms appear. The CDC does not recommend baloxavir antiviral treatment for influenza in pregnant women because there are no data on the safety and efficacy of baloxavir in this population.
Healio: What did your review find?
Stop: Clinical studies of the antiviral treatment of influenza in pregnant women have not been conducted, and recommendations for the antiviral treatment of pregnant women with influenza are based on the results of clinical studies in non-pregnant individuals and observational studies in different populations. No observational studies of baloxavir treatment in pregnant women with influenza have been identified. A reduction in serious clinical outcomes has been reported in several observational studies when pregnant and postpartum women with influenza were treated with oseltamivir or other antiviral drugs against neuraminidase inhibitors at the onset of their illness. Although studies with placental models of animals and humans have shown that oseltamivir and its active substance metabolite oseltamivir carboxylate can cross the placenta, studies in pregnant women who received oseltamivir in different countries have not found an increased risk of adverse outcomes in mothers, fetuses, or newborns . Model studies have shown that pregnant women may need higher doses of oseltamivir than non-pregnant women due to physiological changes during pregnancy. Therefore, additional studies are needed to determine the optimal dosage of oseltamivir for the treatment of influenza during pregnancy.
Overall, given all of the available efficacy and safety data, oseltamivir is the antiviral drug of choice for the treatment of influenza in pregnant women. Ideally, treatment with oseltamivir should be started as soon as possible after the onset of influenza.
Healio: What challenges did you encounter while performing this analysis?
Stop: The main challenge was that, in the absence of randomized controlled clinical trials of the antiviral treatment of influenza in pregnant women, we needed to review the results of available preclinical experimental studies, pharmacokinetic model studies, and observational studies addressing various aspects of antiviral treatment in pregnant women Women with influenza and pregnancy outcomes, and we found that the data for available antiviral drugs other than oseltamivir were very limited.
Healio: Is anyone working on safety and efficacy studies of baloxavir marboxil in pregnant women and when may data be available?
Stop: I am not aware of any clinical studies evaluating the safety and effectiveness 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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