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。