Retrospective 85 pregnant patients in Taiwan, 30 treated with paxlovid, showing higher oxygen requirements, not quite reaching statistical significance (p=0.05), and faster recovery. Patients taking paxlovid for less than three consecutive days were excluded.
Confounding by contraindication. Hoertel et al. find that over 50% of patients that died had a contraindication for the use of Paxlovid
Hoertel. Retrospective studies that do not exclude contraindicated patients may significantly overestimate efficacy.
Black box warning. The FDA notes that
"severe, life-threatening, and/or fatal adverse reactions due to drug interactions have been reported in patients treated with paxlovid" FDA.
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risk of oxygen therapy, 633.3% higher, RR 7.33, p = 0.05, treatment 4 of 30 (13.3%), control 1 of 55 (1.8%).
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recovery time, 35.2% lower, relative time 0.65, p = 0.04, treatment 30, control 55.
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caesarean delivery, 79.5% higher, RR 1.79, p = 0.05, treatment 10 of 13 (76.9%), control 12 of 28 (42.9%).
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small for gestational age, 546.2% higher, RR 6.46, p = 0.09, treatment 3 of 13 (23.1%), control 1 of 28 (3.6%).
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Lin et al., 5 Oct 2023, retrospective, Taiwan, peer-reviewed, 6 authors, study period 29 April, 2022 - 30 July, 2022.
Contact:
yowchi66@hotmail.com, ulin945@gamil.com, nick791027@gmail.com, lovecassiopeia@gmail.com, tsaipy@ncku.edu.tw, sumeitsz@ncku.edu.tw.
Clinical outcomes of nirmatrelvir-ritonavir use in pregnant women during the Omicron wave of the coronavirus disease 2019 pandemic
MD a ; Chih-Wei Lin, MD a ; Yu-Ling Liang, MD a ; Ming-Ta Chuang, MD a ; Chun-Han Tseng, MD Pei-Yin Tsai, MD PhD Mei-Tsz Su
Journal of Infection and Public Health, doi:10.1016/j.jiph.2023.10.007
Background Paxlovid is an oral drug composed of nirmatrelvir and ritonavir that has been demonstrated to be effective in decreasing the risk of severe coronavirus disease 2019 . Here, we report the use of paxlovid in pregnant women with COVID-19.
Methods Pregnant women attending a tertiary referral hospital in Taiwan from 29 April to 30 July 2022 were enrolled in the study. We compared baseline characteristics, clinical manifestations, and adverse events between paxlovid-treated women and those without paxlovid use. Maternal and neonatal outcomes were analysed in women who delivered during the study period.
J o u r n a l P r e -p r o o f
Results A total of 30 paxlovid-treated pregnant women and 55 women without paxlovid use were included in the analysis. The mean duration of COVID-19-associated symptoms in the paxlovid-treated women was shorter than that in the control group (10.10 days versus 15.59 days, p = 0.04). No severe adverse events due to paxlovid use were observed. Dysgeusia and diarrhoea were the most common adverse effects. Thirteen paxlovid-treated and 28 untreated women delivered during the study period. More pregnant women in the paxlovid group who delivered during the study period underwent caesarean delivery compared to the group without antiviral treatment (10 of 13 [76.92%] versus 12 of 28 [42.86%], p = 0.042), and insignificantly more newborns were born small for gestational age in the paxlovid group compared to the control group (3 of 13 [23.08%] versus 1 of 28 [3.57%], p = 0.086).
Conclusion Our study showed that paxlovid was effective and safe for pregnant women during the Omicron wave of the COVID-19 pandemic. A higher proportion of caesarean delivery rates was observed among paxlovidtreated women. Long-term follow-up of pregnant women exposed to paxlovid and their offspring is needed.
J o u r n a l P r e -p r o o f
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