“现实世界”中的丙型肝炎病毒治疗：“真实”患者的治疗效果如何？

Hepatitis C virus treatment in the 'real-world': how well do 'real' patients respond?

作者信息

Deborah Friedman N, Green Joanne H, Weber Hanna M, Stephen Shiny, Lane Stephen E, Ting Alvin Y, Watson Jonathan P

机构信息

Department of Infectious Diseases, Geelong, Victoria, Australia ; Department of Medicine, Geelong, Victoria, Australia.

Deakin University School of Medicine, Geelong, Victoria, Australia.

出版信息

J Clin Exp Hepatol. 2014 Sep;4(3):214-20. doi: 10.1016/j.jceh.2014.07.003. Epub 2014 Jul 25.

DOI:10.1016/j.jceh.2014.07.003

PMID:25755563

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4284209/

Abstract

BACKGROUND

Published clinical trials of the treatment of HCV are largely multicentre prospective pharmaceutical trials. Patients in clinical trials tend to have more favorable outcomes than patients in the 'real-world', due to strict patient selection and differences in treatment conditions and available resources.

OBJECTIVES

To assess the outcomes of Hepatitis C infected patients treated at the Barwon Health Liver Clinic with combination Pegylated interferon (PEG-IFN) and Ribavirin (RBV) therapy and to determine factors associated with a treatment response.

METHODS

Retrospective review of patients who received treatment for Hepatitis C at our institution's Liver Clinic from January 2001-September 2011. Patient demographics, comorbidities, treatment-related parameters and side effects were extracted from medical records and analyzed.

RESULTS

A total of 190 patients (120 male, 70 female) with a mean age of 42.8 years (range 20-68 years) commenced treatment. The most common genotype was genotype 3 (48.9%), followed by genotype 1 (42.6%). 150 of 190 patients (78.9%) completed treatment and had end of treatment data available. 107 of 182 patients, (58.8%) for whom sustained virologic response (SVR) rate data was available achieved an SVR. Overall response rates were; 46.9%, 68.8% and 62.4% in genotypes 1, 2 and 3 respectively. The response rate was significantly lower in 29 patients with documented cirrhosis (20.7%). Age, diabetes and alcohol abuse did not predict treatment response in our cohort. Side effects reported in 81.6% of patients included general malaise, hematological disturbance and psychiatric issues, and necessitated cessation of therapy in 16 patients (8.4%) and dose reduction in 26 patients (13.7%).

CONCLUSIONS

Response rates to combination PEG-IFN and RBV therapy at our institution are comparable to other 'real-world' and pharmaceutical registration trials. Side effects of combination therapy were prominent but resulted in fewer discontinuations of therapy compared to pharmaceutical trials.

摘要

背景

已发表的丙型肝炎治疗临床试验大多是多中心前瞻性药物试验。由于严格的患者选择以及治疗条件和可用资源的差异，临床试验中的患者往往比“现实世界”中的患者有更有利的结果。

目的

评估在巴旺健康肝脏诊所接受聚乙二醇化干扰素（PEG-IFN）和利巴韦林（RBV）联合治疗的丙型肝炎感染患者的治疗结果，并确定与治疗反应相关的因素。

方法

回顾性分析2001年1月至2011年9月在本机构肝脏诊所接受丙型肝炎治疗的患者。从病历中提取患者人口统计学、合并症、治疗相关参数和副作用并进行分析。

结果

共有190例患者（男性120例，女性70例）开始治疗，平均年龄42.8岁（范围20 - 68岁）。最常见的基因型是3型（48.9%），其次是1型（42.6%）。190例患者中有150例（78.9%）完成治疗并可获得治疗结束时的数据。182例有持续病毒学应答（SVR）率数据的患者中有107例（58.8%）实现了SVR。总体应答率分别为：1型46.9%，2型68.8%，3型62.4%。29例有肝硬化记录的患者的应答率显著较低（20.7%）。在我们的队列中，年龄、糖尿病和酗酒并不能预测治疗反应。81.6%的患者报告的副作用包括全身不适、血液学紊乱和精神问题，16例患者（8.4%）因此需要停止治疗，26例患者（13.7%）需要减少剂量。