Safety analysis of simnotrelvir/ritonavir treatment in 189 patients with coronavirus disease 2019
10.3760/cma.j.cn114015-20231211-00878
- VernacularTitle:189例新型冠状病毒感染患者应用先诺特韦/利托那韦治疗的安全性分析
- Author:
Hongmei ZHANG
1
;
Jiayu DENG
1
;
Xiangfeng WANG
1
;
Yanqing SONG
1
Author Information
1. 吉林大学第一医院乐群院区药学部，长春 130031
- Publication Type:Journal Article
- Keywords:
Coronavirus infections;
Antiviral agents;
Safety;
Simnotrelvir;
Ritonavir
- From:
Adverse Drug Reactions Journal
2024;26(5):285-290
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the safety of simnotrelvir/ritonavir in the treatment of coronavirus disease 2019 (COVID-19).Methods:The medical records of adult patients with COVID-19 who were hospitalized in Lequn Branch, Hospital of the First Hospital of Jilin University from June 9 to September 30, 2023 and treated with simnotrelvir/ritonavir were collected. According to whether adverse drug reactions (ADR) related to simnotrelvir/ritonavir occurred, the patients were divided into ADR group and non-ADR group. The clinical data, occurrence time of ADR, clinical manifestations, severity, treatment and outcome of patients were analyzed retrospectively.Results:A total of 189 patients were enrolled in this study, including 92 males (48.7%) and 97 females (51.3%), with a median age of 69 (60.5, 74.0) years. The usage and dosage of simnotrelvir/ritonavir were in accordance with the instructions (0.75 g of simnotrelvir and 0.1 g of ritonavir orally, once every 12 hours for 5 days). ADR related to simnotrelvir/ritonavir occurred in 18 of 189 patients (9.5%). There were no significant differences (all P>0.05) in gender, age, smoking status, COVID-19 classification and the proportion of patients with basic diseases such as hypertension, diabetes, cardiovascular disease, cerebrovascular disease, lung disease, and tumor after surgery between the ADR group (18 patients) and non-ADR group (171 patients). The difference in the propation of patients with liver injury and kidney injury between the 2 groups were statistically significant (both P<0.05). A total of 23 cases of ADR occurred in the ADR group. The occurrence time of ADR was 1 to 8 days after taking simnotrelvir/ritonavir. The clinical manifestations of ADR included digestive system symptoms, elevated transaminases, elevated serum creatinine, elevated serum uric acid, decreased platelet count, decreased white blood cell and neutrophil counts, dizziness, headache, etc. Five patients had 2 kinds of symptoms at the same time. The severity of ADR was grade 1 in 12 patients and grade 2 in 6 patients, and no ≥ grade 3 severe ADR occurred. Except one patient who stopped taking medication due to thrombocytopenia, all other patients completed 5-day treatment. The ADR disappeared after discontinuation of simnotrelvir/ritonavir and 1 to 5 days of symptomatic treatments. Conclusions:Simnotrelvir/ritonavir has a good safety in the treatment for COVID-19. The main ADRs are diarrhea and elevated transaminases, with the severity of grade 1-2 and the ADRs disappear after drug withdrawal. The patients with liver and kidney injury should be more alert to the occurrence of ADR when applying simnotrelvir/ritonavir.
