PSM retrospective 725 hospitalized COVID-19 patients in China compared the effectiveness and safety of the oral antivirals azvudine and paxlovid. There was no significant difference in the risk of disease progression between groups, but azvudine was associated with lower ICU admission and invasive ventilation use.
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 death, 0.2% lower, RR 1.00, p = 1.00, treatment 36 of 264 (13.6%), control 63 of 461 (13.7%), NNT 3381.
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risk of mechanical ventilation, 38.3% higher, RR 1.38, p = 0.04, treatment 61 of 264 (23.1%), control 77 of 461 (16.7%).
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risk of ICU admission, 122.2% higher, RR 2.22, p = 0.05, treatment 14 of 264 (5.3%), control 11 of 461 (2.4%).
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risk of progression, 28.3% higher, RR 1.28, p = 0.07, treatment 72 of 264 (27.3%), control 98 of 461 (21.3%), ICU admission, invasive mechanical ventilation, and in-hospital death, primary outcome.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Wei et al., 13 Oct 2023, retrospective, China, peer-reviewed, 8 authors, study period 1 December, 2022 - 31 January, 2023, this trial compares with another treatment - results may be better when compared to placebo.
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