Flisiak R, Zarębska-Michaluk D, Janczewska E, Staniaszek A, Gietka A, Mazur W, Tudrujek M, Tomasiewicz K, Belica-Wdowik T, Baka-Ćwierz B, Dybowska D, Halota W, Lorenc B, Sitko M, Garlicki A, Berak H, Horban A, Orłowska I, Simon K, Socha Ł, Wawrzynowicz-Syczewska M, Jaroszewicz J, Deroń Z, Czauż-Andrzejuk A, Citko J, Krygier R, Piekarska A, Laurans Ł, Dobracki W, Białkowska J, Tronina O, Pawłowska M
Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok, Poland.
Department of Infectious Diseases, Voivodship Hospital and Jan Kochanowski University, Kielce, Poland.
J Viral Hepat. 2018 Jun;25(6):661-669. doi: 10.1111/jvh.12861. Epub 2018 Feb 6.
The aim of the EpiTer-2 study was to analyse patient characteristics and their medication for HCV infection in Poland at the beginning of the interferon-free era. Analysis of data of HCV infected patients treated during the initial period of availability of interferon-free regimens in Poland, who started therapy after 1 July 2015 and had available an efficacy evaluation report before 30 June 2017 was undertaken. A total of 2879 patients with chronic hepatitis C were entered, including 46% with liver cirrhosis. The most common was genotype 1b (86.8%). The study population was gender balanced, the majority of patients were overweight or obese and 69% presented comorbidities, with the highest prevalence that for hypertension. More than half of patients were retreated due to failure of previous therapy with pegylated interferon and ribavirin. Almost two-third of patients received current therapy with ombitasvir/paritaprevir/ritonavir±dasabuvir (OPrD) ±ribavirin. Other patients received mostly sofosbuvir-based regimens including combination with ledipasvir and pegylated interferon and ribavirin for genotype 3-infected patients. Efficacy of treatment in the whole study population measured as intent-to-treat analysis was 95%. The most frequent regimen, administered for patients infected with genotype 1b, was 12 weeks of OPrD, resulting in an SVR rate of 98%. At least one adverse event was reported in 38% of patients, and the death rate was 0.8%. In conclusion, data from the EpiTer-2 study confirmed the excellent efficacy and safety profile of the real-world experience with recently introduced therapeutic options for genotype 1 HCV infection, but demonstrated weakness of the current therapeutic programme regarding genotype 3 infections.
EpiTer-2研究的目的是分析在无干扰素时代初期波兰丙型肝炎病毒(HCV)感染患者的特征及其用药情况。对波兰无干扰素治疗方案可用初期接受治疗的HCV感染患者的数据进行了分析,这些患者于2015年7月1日之后开始治疗,并在2017年6月30日之前有疗效评估报告。共纳入2879例慢性丙型肝炎患者,其中46%患有肝硬化。最常见的基因型是1b型(86.8%)。研究人群性别均衡,大多数患者超重或肥胖,69%有合并症,其中高血压患病率最高。超过一半的患者因之前聚乙二醇干扰素和利巴韦林治疗失败而接受再次治疗。近三分之二的患者目前接受ombitasvir/paritaprevir/ritonavir±dasabuvir(OPrD)±利巴韦林治疗。其他患者大多接受以索磷布韦为基础的治疗方案,包括与来迪帕司韦联合以及针对3型基因型感染患者的聚乙二醇干扰素和利巴韦林联合治疗。以意向性分析衡量,整个研究人群的治疗有效率为95%。针对1b型基因型感染患者最常用的治疗方案是12周的OPrD,持续病毒学应答率为98%。38%的患者报告了至少一种不良事件,死亡率为0.8%。总之,EpiTer-2研究的数据证实了近期引入的1型HCV感染治疗方案在真实世界中的卓越疗效和安全性,但也显示了当前治疗方案在3型基因型感染方面的不足。