Medeiros Thalia, Salviato Camila de Morais, do Rosário Natalia Fonseca, Saraiva Geórgia do Nascimento, Esberard Eliane Bordalo Cathalá, Almeida Jorge Reis, Xavier Analúcia Rampazzo, da Silva Andrea Alice
Laboratório Multiusuário de Apoio à Pesquisa em Nefrologia e Ciências Médicas, Departamento de Medicina Clínica, Faculdade de Medicina, Universidade Federal Fluminense, Rio de Janeiro, Brazil.
Centro de Referência de Tratamento em Hepatites/HUAP, Serviço de Gastroenterologia, Departamento de Medicina Clínica, Faculdade de Medicina, UFF, Rio de Janeiro, Brazil.
Int J Clin Pharm. 2017 Dec;39(6):1304-1311. doi: 10.1007/s11096-017-0552-1. Epub 2017 Oct 27.
Background Direct-acting antivirals (DAA) are currently used for the treatment of chronic hepatitis C (HCV). However, few studies describe the adverse effects (AE) associated with DAA therapy in "real-word" cohorts. Aim To evaluate AE in Brazilian chronic HCV patients after DAA-therapy. Setting A reference center for hepatitis treatment in Rio de Janeiro, Brazil. Methods An observational "real-world" study was conducted with 102 chronic HCV patients undergoing DAA therapy for 12 or 24 weeks. The self-reported AE were correlated with cirrhosis status, genotype, age, current therapeutic schemes and comorbidities. Serious AE were also investigated. Main outcome measure Frequency of AE during DAA therapy. Results Overall, mean ± SD age was 60.9 ± 9.4 years, 67% were females, HCV-genotype 1 was the most prevalent (81%) and 74% were cirrhotic. Moreover, all patients reached sustained virological response. About 90% of patients reported at least one AE associated with current treatment, with a mean of 2.7 symptoms per patient. The most frequently reported AE were fatigue (43%), headache (42%), neuropsychiatric symptoms (30%) and nausea (26%). Furthermore, hemoglobin < 12 mg/dL was the most frequent (38%) laboratory abnormality observed. Neuropsychiatric symptoms were the only AE significantly different in treatment-experienced group when compared to naïve patients (41.7 vs. 12.5, P = 0.002). The higher frequency of AE did not correlate with the presence of previous treatment, cirrhosis, genotype, age, current therapeutic schemes with DAA or comorbidities. Conclusion DAA-based therapeutic regimens demonstrated safety in a Brazilian "real-world" cohort of chronic hepatitis C patients.
背景 直接作用抗病毒药物（DAA）目前用于治疗慢性丙型肝炎（HCV）。然而，很少有研究描述在“真实世界”队列中与DAA治疗相关的不良反应（AE）。目的 评估巴西慢性HCV患者接受DAA治疗后的AE。地点 巴西里约热内卢的一家肝炎治疗参考中心。方法 对102例接受DAA治疗12周或24周的慢性HCV患者进行了一项观察性“真实世界”研究。自我报告的AE与肝硬化状态、基因型、年龄、当前治疗方案和合并症相关。还对严重AE进行了调查。主要观察指标 DAA治疗期间AE的发生率。结果 总体而言，平均年龄±标准差为60.9±9.4岁，67%为女性，HCV基因型1最为常见（81%），74%为肝硬化患者。此外，所有患者均达到持续病毒学应答。约90%的患者报告至少有一种与当前治疗相关的AE，每位患者平均有2.7种症状。最常报告的AE是疲劳（43%）、头痛（42%）、神经精神症状（30%）和恶心（26%）。此外，血红蛋白<12mg/dL是观察到的最常见（38%）实验室异常。与初治患者相比，神经精神症状是经治组唯一有显著差异的AE（41.7对12.5，P=0.002）。AE的较高发生率与既往治疗史、肝硬化、基因型、年龄、当前DAA治疗方案或合并症无关。结论 在巴西慢性丙型肝炎患者的“真实世界”队列中，基于DAA的治疗方案显示出安全性。
