Analysis of efavirenz-related rashes in healthy subjects in drug clinical trials and literature review
10.3760/cma.j.cn114015-20221207-01132
- VernacularTitle:药物临床试验中健康受试者依非韦伦相关皮疹分析及文献回顾
- Author:
Jin WANG
1
;
Lan ZHANG
1
;
Chaoying HU
1
Author Information
1. 首都医科大学宣武医院药学部Ⅰ期临床研究中心，北京 100053
- Publication Type:Journal Article
- Keywords:
Healthy volunteers;
Clinical trial;
Pharmacokinetics;
Drug interactions;
Efavirenz;
Drug eruptions;
Safety;
Cytochrome P-450 enzyme inducers
- From:
Adverse Drug Reactions Journal
2023;25(9):521-526
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the occurrence of rashes in healthy subjects caused by efavirenz in drug clinical trials.Methods:The occurrence of rashes related to efavirenz, which was used as an enzyme inducer, in healthy subjects in 2 clinical trials conducted by the Phase I Clinical Research Center of the Department of Pharmacy, Xuanwu Hospital, Capital Medical University (our hospital) in November 2020 and October 2021 was retrospectively analyzed. The relevant databases at home and abroad (up to November 30, 2022) were searched, and the literature, in which efavirenz was applied as trial drug or enzyme inducer in healthy subjects, were collected. The cases of efavirenz-related rashes reported in the literature were reviewed. The clinical characteristics of the cases in the literature and above 2 clinical trials in our hospital were summarized and analyzed by descriptive statistics.Results:A total of 40 healthy subjects were included in the 2 clinical trials, and 5 (12.5%) developed efavirenz-related rashes. The average time from taking the medicine to the appearance of rashes was 8 days. The initial symptom was skin itching. The rashes occurred mainly on the limbs and back, and mainly presented as maculopapular rashes, without other symptoms or laboratory abnormalities. Four subjects withdrew from the trial and the rashes subsided after 5-7 days of anti-allergic and symptomatic treatments; one subject was given calamine lotion for external use because of mild rashes, and continued to participate in the trial. His rashes subsided 17 days later (5 days after stopping efavirenz). Eighteen literature in which efavirenz was used as a trial drug or enzyme inducer in healthy subjects were retrieved. A total of 403 healthy subjects collected from 18 literature and our trials were included in the analysis. Of them, 19 subjects developed rashes, with a incidence of 4.7%. According to the daily dose of efavirenz, the incidence of rashes in the subjects of the 600 mg/d group was higher than that of the <600 mg/d group, but the difference was not statistically significant [5.5% (18/329) vs. 1.4% (1/74), P=0.131]. According to the course of drug, the incidence of rashes was similar in subjects between the single dose group and the continuous dose group [4.1% (4/97) vs. 4.9% (15/306), P=0.753]. Conclusion:Rashes are common adverse reactions in healthy subjects after taking efavirenz, which is generally mild and can subside after timely detection and treatment.
