Department of Clinical and Experimental Medicine, Brighton and Sussex Medical School (BSMS), Brighton, UK.
Department of Gastroenterology and Hepatology, Brighton and Sussex University Hospital (BSUH) NHS Trust, Brighton, UK.
J Med Virol. 2019 Nov;91(11):1979-1988. doi: 10.1002/jmv.25552. Epub 2019 Aug 5.
Direct-acting antivirals (DAAs) have revolutionised the management of chronic hepatitis C virus (HCV) infection. We describe UK real-world DAA experience. Individuals commencing HCV treatment containing a DAA regimen (Mar 2014-Nov 2016), participating in the National HCV Research UK (HCVRUK) Cohort Study were recruited from 33 UK HCV centers. The data were prospectively entered at sites onto a centralised database. The data were reported as median (Q1-Q3). Of the 1448 treated patients, 1054 (73%) were males, the median age being 54 years (47-60), 900 (62%) being genotype 1 and 455 (31%) genotype 3. The majority, 887 (61%) had cirrhosis, and 590 (41%) were treatment-experienced. DAA regimens utilised: genotype1 sofosbuvir (SOF)/Ledipasvir/±Ribavirin (625/900, 69%) and Ombitasvir/Paritaprevir/Dasabuvir/±RBV (220/900, 24%), and in genotype 3 SOF/Daclatasvir + RBV (256/455, 56%) and SOF/pegylated interferon/RBV (157/455, 35%). Overall, 1321 (91%) achieved sustained virological response (SVR12), genotype 1 vs 3, 93% vs 87%, P < .001. Prior treatment, presence of cirrhosis and treatment regimen did not impact SVR12. Predictors of treatment failure were genotype 3 infection, OR, 2.015 (95% CI: 1.279-3.176, P = .003), and male sex, OR, 1.878 (95% CI: 1.071-3.291, P = .028). Of those with hepatic decompensation at baseline (n = 39), 51% (n = 20) recompensated post-treatment, lower baseline serum creatinine being associated with recompensation (P = .029). There were two liver-related deaths, both having decompensated disease. This real-world UK data, comprising of a predominantly cirrhotic HCV genotype 1/3 cohort, confirms DAA efficacy with an overall 91% SVR12, with 51% recompensating post-treatment. Genotype 3 infection was a predictor of treatment failure.
直接作用抗病毒药物（DAAs）彻底改变了慢性丙型肝炎病毒（HCV）感染的治疗方式。我们描述了英国的真实世界 DAA 经验。2014 年 3 月至 2016 年 11 月，参加英国国家 HCV 研究 UK（HCVRUK）队列研究的 33 个英国 HCV 中心招募了开始接受包含 DAA 方案的 HCV 治疗的个体。数据前瞻性地在现场输入到集中数据库中。数据以中位数（Q1-Q3）报告。在 1448 名接受治疗的患者中，1054 名（73%）为男性，中位年龄为 54 岁（47-60 岁），900 名（62%）为基因型 1，455 名（31%）为基因型 3。大多数患者（887 名，61%）患有肝硬化，590 名（41%）为治疗经验丰富的患者。使用的 DAA 方案：基因型 1 的索非布韦（SOF）/雷迪帕韦/±利巴韦林（625/900，69%）和奥比他韦/帕利他韦/达卡他韦/±RBV（220/900，24%），以及基因型 3 的 SOF/达卡他韦+RBV（256/455，56%）和 SOF/聚乙二醇干扰素/RBV（157/455，35%）。总的来说，1321 名（91%）患者获得持续病毒学应答（SVR12），基因型 1 为 93%，基因型 3 为 87%，P<0.001。既往治疗、肝硬化的存在和治疗方案均未影响 SVR12。治疗失败的预测因素是基因型 3 感染，OR，2.015（95%CI：1.279-3.176，P=0.003），以及男性，OR，1.878（95%CI：1.071-3.291，P=0.028）。基线时有肝失代偿（n=39）的患者中，51%（n=20）在治疗后代偿，较低的基线血清肌酐与代偿相关（P=0.029）。有 2 例与肝脏相关的死亡，均为失代偿性疾病。该英国真实世界数据主要包含基因型 1/3 肝硬化 HCV 患者队列，证实 DAA 的疗效为总体 SVR12 为 91%，51%的患者在治疗后代偿。基因型 3 感染是治疗失败的预测因素。
