Evaluating the safety and efficacy of nirmatrelvir-ritonavir therapy in pregnant women with COVID-19: a systematic review and meta-analysis.

IF 2.4 3区医学 Q3 PHARMACOLOGY & PHARMACY

European Journal of Clinical Pharmacology Pub Date : 2025-04-01 Epub Date: 2025-02-13 DOI:10.1007/s00228-025-03808-8

Omar Hassan, Aya Abdulkarim Elbhairy, Aya Magdy Siam, Tasneem Abdelwahab, Albraa Ashraf Hamad, Omar Ehab Mahmoud, Omnia Azmy Nabeh

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Abstract

Purpose: Pregnant women are at heightened risk for severe COVID-19 outcomes. However, treatment options during pregnancy remain limited due to concerns over their safety and efficacy.

Methods: This systematic review and meta-analysis assessed the safety and efficacy of nirmatrelvir-ritonavir in pregnant women diagnosed with mild-to-moderate COVID-19. The analysis focused on cases where the treatment was initiated within five days of symptom onset. A single-arm meta-analysis was performed to comprehensively evaluate outcomes across maternal, delivery, and neonatal domains.

Results: In line with PRISMA guidelines, six studies involving a total of 427 pregnant patients were included in the analysis. Hospitalization was reported in 2% of patients (95% CI: 1%-5%), with low heterogeneity across studies (I² = 21.9%). Drug discontinuation and new-onset gestational diabetes (NOGDM) had a pooled estimate of 0.7% (95% CI: 3% to 15%) and 4.0% (95% CI: 1% to 16%), respectively, with substantial heterogeneity (I² = 64.7% and 66.5%), respectively. New-onset gestational hypertension (NOGHTN) had a pooled estimate of 4% (95% CI: 1% to 26%), with considerable heterogeneity (I² = 78.81%). For neonatal outcomes, the pooled estimate for birth weight was 3186 g (95% CI: 3123-3248 g; I² = 0%), and no maternal or neonatal deaths were reported across the included studies.

Conclusion: Nirmatrelvir-ritonavir appears safe and effective for mild-to-moderate COVID-19 in pregnant women, with low rates of hospitalization and adverse maternal outcomes. Larger, randomized studies are crucial to confirm these findings and ensure safety in diverse populations.

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评估尼马特韦-利托那韦治疗COVID-19孕妇的安全性和有效性：一项系统评价和荟萃分析

目的：孕妇发生COVID-19严重后果的风险更高。然而，由于对其安全性和有效性的担忧，怀孕期间的治疗选择仍然有限。方法：本系统综述和荟萃分析评估了尼马特利韦-利托那韦治疗轻中度COVID-19孕妇的安全性和有效性。分析的重点是在症状出现后5天内开始治疗的病例。进行单臂荟萃分析以全面评估孕产妇、分娩和新生儿领域的结局。结果：与PRISMA指南一致，6项研究共纳入427例妊娠患者。2%的患者住院（95% CI: 1%-5%），研究间异质性较低（I2 = 21.9%）。停药和新发妊娠糖尿病（NOGDM）的合并估计分别为0.7% （95% CI: 3%至15%）和4.0% (95% CI: 1%至16%)，具有显著的异质性（I2分别= 64.7%和66.5%）。新发妊娠期高血压（NOGHTN）的合并估计为4% (95% CI: 1%至26%)，具有相当大的异质性（I2 = 78.81%）。对于新生儿结局，出生体重的汇总估计为3186 g (95% CI: 3123-3248 g；I2 = 0%)，在纳入的研究中没有报告孕产妇或新生儿死亡。结论：尼马特利韦-利托那韦对轻至中度COVID-19孕妇安全有效，住院率低，孕产妇不良结局低。更大规模的随机研究对于证实这些发现并确保在不同人群中的安全性至关重要。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Journal of Clinical Pharmacology 医学-药学

CiteScore

5.40

自引率

3.40%

发文量

170

审稿时长

3-8 weeks

期刊介绍： The European Journal of Clinical Pharmacology publishes original papers on all aspects of clinical pharmacology and drug therapy in humans. Manuscripts are welcomed on the following topics: therapeutic trials, pharmacokinetics/pharmacodynamics, pharmacogenetics, drug metabolism, adverse drug reactions, drug interactions, all aspects of drug development, development relating to teaching in clinical pharmacology, pharmacoepidemiology, and matters relating to the rational prescribing and safe use of drugs. Methodological contributions relevant to these topics are also welcomed. Data from animal experiments are accepted only in the context of original data in man reported in the same paper. EJCP will only consider manuscripts describing the frequency of allelic variants in different populations if this information is linked to functional data or new interesting variants. Highly relevant differences in frequency with a major impact in drug therapy for the respective population may be submitted as a letter to the editor. Straightforward phase I pharmacokinetic or pharmacodynamic studies as parts of new drug development will only be considered for publication if the paper involves -a compound that is interesting and new in some basic or fundamental way, or -methods that are original in some basic sense, or -a highly unexpected outcome, or -conclusions that are scientifically novel in some basic or fundamental sense.