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口服奈玛特韦/利托那韦对 SARS-CoV-2 奥密克戎变异株的短期疗效及培养阳性病毒脱落情况

Short-Term Effectiveness of Oral Nirmatrelvir/Ritonavir Against the SARS-CoV-2 Omicron Variant and Culture-Positive Viral Shedding.

机构信息

Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea.

National Institute of Infectious Diseases, Korea National Institute of Health, Korea Disease Control and Prevention Agency, Cheongju, Korea.

出版信息

J Korean Med Sci. 2023 Feb 27;38(8):e59. doi: 10.3346/jkms.2023.38.e59.

DOI:10.3346/jkms.2023.38.e59

PMID:36852855

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9970787/

Abstract

BACKGROUND

Information on the effectiveness of nirmatrelvir/ritonavir against the omicron is limited. The clinical response and viral kinetics to therapy in the real world need to be evaluated.

METHODS

Mild to moderate coronavirus disease 2019 (COVID-19) patients with risk factors for severe illness were prospectively enrolled as a treatment group with nirmatrelvir/ritonavir therapy versus a control group with supportive care. Serial viral load and culture from the upper respiratory tract were evaluated for seven days, and clinical responses and adverse reactions were evaluated for 28 days.

RESULTS

A total of 51 patients were analyzed including 40 in the treatment group and 11 in the control group. Faster symptom resolution during hospitalization ( = 0.048) was observed in the treatment group. Only minor adverse reactions were reported in 27.5% of patients. The viral load on Day 7 was lower in the treatment group ( = 0.002). The viral culture showed a positivity of 67.6% (25/37) vs. 100% (6/6) on Day 1, 0% (0/37) vs. 16.7 (1/6) on Day 5, and 0% (0/16) vs. 50.0% (2/4) on Day 7 in the treatment and control groups, respectively.

CONCLUSIONS

Nirmatrelvir/ritonavir against the omicron was safe and resulted in negative viral culture conversion after Day 5 of treatment with better symptomatic resolution.

摘要

背景

关于奈玛特韦/利托那韦对奥密克戎的有效性信息有限。需要评估真实世界中治疗的临床反应和病毒动力学。

方法

前瞻性纳入有重症风险因素的轻度至中度 2019 冠状病毒病（COVID-19）患者，作为奈玛特韦/利托那韦治疗的治疗组与支持性护理的对照组。连续评估七天的上呼吸道病毒载量和培养，评估 28 天的临床反应和不良反应。

结果

共分析了 51 例患者，其中治疗组 40 例，对照组 11 例。治疗组住院期间症状缓解更快（ = 0.048）。仅 27.5%的患者报告有轻微不良反应。治疗组第 7 天的病毒载量较低（ = 0.002）。病毒培养显示第 1 天治疗组的阳性率为 67.6%（25/37），对照组为 100%（6/6），第 5 天治疗组为 0%（0/37），对照组为 16.7%（1/6），第 7 天治疗组为 0%（0/16），对照组为 50.0%（2/4）。