Factors associated with treatment failure of direct-acting antivirals for chronic hepatitis C: A real-world nationwide hepatitis C virus registry programme in Taiwan.
Factors associated with treatment failure of direct-acting antivirals for chronic hepatitis C: A real-world nationwide hepatitis C virus registry programme in Taiwan.
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与直接作用抗病毒药物治疗慢性丙型肝炎失败相关的因素：台湾真实世界的全国性丙型肝炎病毒登记计划。
DOI：
10.1111/liv.14849
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发表时间：
2021-06
期刊：
影响因子：
--
通讯作者：
Yu ML
中科院分区：
文献类型：
--
作者：
Chen CY;Huang CF;Cheng PN;Tseng KC;Lo CC;Kuo HT;Huang YH;Tai CM;Peng CY;Bair MJ;Chen CH;Yeh ML;Lin CL;Lin CY;Lee PL;Chong LW;Hung CH;Huang JF;Yang CC;Hu JT;Lin CW;Chen CT;Wang CC;Su WW;Hsieh TY;Lin CL;Tsai WL;Lee TH;Chen GY;Wang SJ;Chang CC;Mo LR;Yang SS;Wu WC;Huang CS;Hsiung CK;Kao CN;Tsai PC;Liu CH;Lee MH;Liu CJ;Dai CY;Kao JH;Chuang WL;Lin HC;Yu ML
直接作用抗病毒药物（DAA）在治疗慢性丙型肝炎病毒（HCV）感染患者方面非常有效。在全国范围内，台湾患者的真实的世界治疗结果是难以捉摸的。台湾HCV登记（TACR）计划是一个全国性的登记平台，包括48个研究中心，由台湾肝脏研究协会组织和监督。主要终点为持续病毒学应答（SVR 12，治疗结束后12周检测不到HCV RNA）。共分析了13951例具有可用SVR 12数据的登记患者（平均年龄63.0岁;女性55.9%; HCV基因型-1（GT 1）57.9%;肝硬化38.4%;既存肝细胞癌（HCC）10.6%;和B型肝炎病毒合并感染7.7%）。总体SVR 12率为98.3%，初治非炎性、初治炎性、经治非炎性和经治炎性患者分别为98.7%、98.0%、98.4%和97.4%。所有亚组的SVR 12率均> 95%，但接受索非布韦/利巴韦林治疗的有治疗经验的腹泻患者（88.7%）、未经治疗的非腹泻患者（94.8%）和接受达卡他韦/阿舒那匹韦治疗的有治疗经验的腹泻患者（94.8%）除外。与治疗失败相关的最重要因素是DAA依从性< 60%（调整后的比值比[aOR]/95%置信区间[CI]：117.1/52.4 - 261.3，P < .001），其次是GT3/GT 2（aOR/CI：5.78/2.25 - 14.9，P = .0003和aOR/CI：1.55/1.05 - 2.29，P = .03，与GT 1相比），活动性肝细胞癌（aOR/CI：4.29/2.57 - 7.16，P < .001），使用索非布韦/利巴韦林（aOR/CI：2.51/1.67 - 3.77，P < .001）和达卡他韦/阿舒那匹韦（aOR/CI：3.29/1.94 - 5.58，P < .001），失代偿期肝硬化（aOR/CI：2.50/1.20 - 5.22，P = .02）和高HCV病毒载量（aOR/CI：2.16/1.57 - 2.97，P < .001）。DAA在真实的世界环境中治疗台湾HCV患者非常有效。维持DAA依从性和选择高效方案是确保治疗成功的关键。
Direct‐acting antivirals (DAAs) are highly effective in treating chronic hepatitis C virus (HCV)‐infected patients. The real‐world treatment outcome in Taiwanese patients on a nationwide basis is elusive. The Taiwan HCV Registry (TACR) programme is a nationwide registry platform including 48 study sites, which is organized and supervised by the Taiwan Association for the Study of the Liver. The primary endpoint was sustained virological response (SVR12, undetectable HCV RNA 12 weeks after end‐of‐treatment). A total of 13 951 registered patients with SVR12 data available were analysed (mean age, 63.0 years; female, 55.9%; HCV genotype‐1 [GT1], 57.9%; cirrhosis, 38.4%; preexisting hepatocellular carcinoma [HCC], 10.6%; and hepatitis B virus coinfection, 7.7%). The overall SVR12 rate was 98.3%, with 98.7%, 98.0%, 98.4% and 97.4% in treatment‐naïve noncirrhotic, treatment‐naïve cirrhotic, treatment‐experienced noncirrhotic and treatment‐experienced cirrhotic patients, respectively. The SVR12 rate was > 95% across all subgroups except treatment‐experienced cirrhotic patients who received sofosbuvir/ribavirin (88.7%), treatment‐naïve noncirrhotic patients (94.8%) and treatment‐experienced cirrhotic (94.8%) patients who received daclatasvir/asunaprevir. The most important factor associated with treatment failure was DAA adherence < 60% ( adjusted odds ratio [aOR]/95% confidence interval [CI]: 117.1/52.4‐261.3, P < .001), followed by GT3/GT2 (aOR/CI: 5.78/2.25‐14.9, P = .0003 and aOR/CI: 1.55/1.05‐2.29, P = .03, compared with GT1), active hepatocellular carcinoma (aOR/CI: 4.29/2.57‐7.16, P < .001), the use of sofosbuvir/ribavirin (aOR/CI: 2.51/1.67‐3.77, P < .001) and daclatasvir/asunaprevir (aOR/CI: 3.29/1.94‐5.58, P < .001), decompensated liver cirrhosis (aOR/CI: 2.50/1.20‐5.22, P = .02) and high HCV viral loads (aOR/CI: 2.16/1.57‐2.97, P < .001). DAAs are highly effective in treating Taiwanese HCV patients in the real‐world setting. Maintaining DAA adherence and selecting highly efficacious regimens are keys to ensure treatment success.
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DOI：
10.1016/j.jmii.2018.10.002
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2019-08-01
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