Safety analysis of nirmatrelvir/ritonavir in the treatment of coronavirus disease 2019
10.3760/cma.j.cn114015-20220812-00739
- VernacularTitle:奈玛特韦/利托那韦治疗新型冠状病毒感染的安全性分析
- Author:
Jin'e PENG
1
;
Hui LIU
;
Xiao LI
;
Lijun WANG
;
Shuo WANG
;
Haofan SU
;
Hanqiu ZHAN
;
Wei ZHANG
Author Information
1. 首都医科大学附属北京地坛医院药学部，北京 100015
- Publication Type:Journal Article
- Keywords:
COVID-19;
Antiviral agents;
Safety;
Ritonavir;
Nirmatrelvir
- From:
Adverse Drug Reactions Journal
2023;25(1):11-16
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the safety of nirmatrelvir/ritonavir (Paxlovid) in the treatment of coronavirus disease 2019 (COVID-19).Methods:Medical records of adult patients with COVID-19 who were hospitalized and treated with Paxlovid in Beijing Ditan Hospital, Capital Medical University between March 23 and May 31, 2022 were collected through the hospital electronic medical record system. The occurrence (time of occurrence, clinical manifestations, severity, etc.) and outcomes of adverse reactions were analyzed retrospectively and the clinical characteristics of patients with or without adverse reactions were compared. Paxlovid was administered orally with nirmatrelvir 300 mg and ritonavir 100 mg every 12 hours for 5 consecutive days.Results:Three hundred and sixty-four patients were entered in the analysis, including 200 males (54.9%) and 164 females (45.1%), with a median age of 60 (19, 92) years. The incidence of adverse reactions of Paxlovid was 13.2% (48/364), and the adverse reactions occurred 1 to 7 days after taking Paxlovid. Among the 48 patients, 37 patients had digestive system symptoms (mainly manifested as diarrhea in 17 patients, bitter mouth in 14 patients, etc.), 7 patients had nervous system symptoms (dizziness in 5 patients, headache in 2 patients), 4 patients had respiratory system symptoms (pharyngalgia in 3 patients, pharyngeal itching in 1 patient), 2 patients had kidney injury, 1 patient had elevated blood uric acid, 1 patient had myalgia, and 1 patient had rash. Of them, 2 patients had digestive and neurological symptoms at the same time, 1 patient had digestive and respiratory symptoms at the same time, and 1 patient had digestive, neurological, and respiratory symptoms at the same time. The severity of adverse reactions was grade 1 in 33 patients (68.8%) and grade 2 in 15 patients (31.2%), and no serious adverse reactions of grade 3 and above occurred. All patients completed 5 days of treatment except 1 patient who discontinued the drug because of intolerance to grade 2 digestive symptoms (nausea and bitter mouth). There were no significant differences in gender, age, body mass index, smoking status, underlying diseases, and COVID-19 clinical classification between the patients with and without adverse reactions (all P>0.05). Conclusions:Paxlovid has a good safety in the treatment of COVID-19. The main adverse reaction is digestive system symptoms, mainly diarrhea and bitter mouth. Most of the symptoms are mild and the patient′s tolerance is good.
