Juanbeltz Regina, Goñi Esarte Silvia, Úriz-Otano Juan Isidro, Martínez Echeverría Ana, Elizalde Inmaculada, Zozaya José Manuel, Castilla Jesús, San Miguel Ramón
a Department of Pharmacy , Complejo Hospitalario de Navarra , Pamplona , Spain.
b CIBER Epidemiología y Salud Pública (CIBERESP) , Madrid , Spain.
Postgrad Med. 2017 May;129(4):476-483. doi: 10.1080/00325481.2017.1311197. Epub 2017 Apr 10.
Direct acting antivirals (DAA) are extremely effective to treat chronic hepatitis C. The aim of this study was to evaluate, by using objective variables, the safety of DAA combinations under clinical practice conditions.
A retrospective study was carried out in mono-infected patients with chronic hepatitis C treated with DAA between January and December 2015 in our centre. Discontinuations, treatment modifications, deaths and laboratory parameters were studied (liver function tests, hemoglobin, creatinine and lipid profile at baseline, weeks 4, 8 and post 12). Temporal variation of laboratory parameters was analyzed by t-test for paired data, and comparison between groups was made by t-test for independent samples and ANOVA.
227 patients were included (40.5% cirrhotic). Sustained virological response (SVR) was achieved in 97.3% of patients. In only one case was the antiviral medication suspended due to toxicity, and there were no voluntary treatment discontinuations. The use of ribavirin (RBV) was associated with mild transient hyperbilirubinemia (41.2%) and anemia (32.6%, with RBV dose reduction in 7.9% of cases). There was an elevation in total cholesterol and LDL-cholesterol (LDL-C) during and after treatment: mean increase of 23 mg/dL (0.59 mmol/L) and 22 mg/dL (0.57 mmol/L), respectively in post 12 (p < .0001). An increment of 20% of patients with cholesterol levels over optimal figures was observed after DAA completion.
DAA have an optimum safety profile in real life conditions, with infrequent discontinuation and minor laboratory alterations.
直接作用抗病毒药物（DAA）治疗慢性丙型肝炎极为有效。本研究旨在通过客观变量评估临床实践条件下DAA联合用药的安全性。
对2015年1月至12月在本中心接受DAA治疗的慢性丙型肝炎单感染患者进行回顾性研究。研究了停药情况、治疗调整、死亡情况及实验室参数（基线、第4周、第8周和第12周后肝功能检查、血红蛋白、肌酐和血脂谱）。实验室参数的时间变化采用配对数据t检验进行分析，组间比较采用独立样本t检验和方差分析。
纳入227例患者（40.5%为肝硬化患者）。97.3%的患者实现了持续病毒学应答（SVR）。仅1例因毒性而停用抗病毒药物，无自愿停药情况。利巴韦林（RBV）的使用与轻度短暂性高胆红素血症（41.2%）和贫血（32.6%，7.9%的病例减少了RBV剂量）相关。治疗期间及治疗后总胆固醇和低密度脂蛋白胆固醇（LDL-C）升高：第12周后分别平均升高23mg/dL（0.59mmol/L）和22mg/dL（0.57mmol/L）（p<0.0001）。DAA治疗结束后，胆固醇水平超过最佳值的患者增加了20%。
在现实生活条件下，DAA具有最佳的安全性，停药情况罕见，实验室改变轻微。
