Real-world efficacy of elbasvir and grazoprevir for hepatitis C virus (genotype 1): A nationwide, multicenter study by the Japanese Red Cross Hospital Liver Study Group
Real-world efficacy of elbasvir and grazoprevir for hepatitis C virus (genotype 1): A nationwide, multicenter study by the Japanese Red Cross Hospital Liver Study Group
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DOI：
10.1111/hepr.13362
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发表时间：
2019-10-01
影响因子：
4.2
通讯作者：
Izumi，Namiki
中科院分区：
文献类型：
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作者：
Mashiba，Toshie;Joko，Kouji;Izumi，Namiki
目的本研究旨在确定非结构蛋白（NS）5A抑制剂elbasvir （EBR）联合NS3/4A蛋白酶抑制剂grazoprevir （GZR）治疗丙型肝炎病毒（HCV）基因1型（GT1）感染患者的实际疗效和安全性。方法本研究回顾性评估治疗后12周持续病毒学应答率（SVR12）和EBR/GZR治疗的安全性，研究对象为159名男性和194名女性，中位年龄为72岁，并评估与SVR12率相关的因素。在本回顾性研究中，主治医生负责选择EBR/GZR候选患者。结果直接作用抗病毒药物（DAA‐naïve）患者EBR/GZR治疗效果良好，其中99.4%达到SVR。353例患者中，10例（2.9%）治疗失败。在这些患者中，8例先前接受过DAA治疗，其余2例患有NS5A‐L31/Y93双突变。先前接受DAA治疗的患者的SVR为50%（8/16例），NS5A‐L31/Y93双突变患者的SVR为18.2%（2/11例）。在多因素logistic回归分析中，NS5A‐Y31/Y93双突变（优势比356.3；95%可信区间23.91 ~ 16940；P< 0.0001）被确定为治疗失败的独立预测因子。EBR/GZR治疗组未观察到严重不良事件。结论无DAA治疗史或双突变患者EBR/GZR的SVR率为100%。这种药物组合可以安全地给予，因此被认为是DAA‐naïve HCV患者非常有用的一线治疗方法。
AimThe present study aimed to determine the real‐world efficacy and safety of the non‐structural protein (NS)5A inhibitor elbasvir (EBR) combined with the NS3/4A protease inhibitor grazoprevir (GZR) in patients with hepatitis C virus (HCV) genotype 1 (GT1) infection.MethodsThis study retrospectively evaluated the rate of sustained virologic response at 12 weeks post‐treatment (SVR12) and the safety of EBR/GZR treatment in 159 men and 194 women with a median age of 72 years, and it assessed factors associated with the SVR12 rate. The attending physicians were responsible for selecting candidate patients for EBR/GZR in this retrospective study.ResultsTreatment outcomes for EBR/GZR were good in direct‐acting antiviral (DAA)‐naïve patients, of whom 99.4% achieved SVR. Of 353 patients, 10 (2.9%) had treatment failure. Of these patients, eight previously underwent DAA therapy, and the remaining two had NS5A‐L31/Y93 double mutation. The SVR rate was 50% (8/16 patients) in patients who previously underwent DAA therapy, and 18.2% (2/11 patients) in patients with NS5A‐L31/Y93 double mutation. On multivariate logistic regression analysis, NS5A‐Y31/Y93 double mutation (odds ratio 356.3; 95% confidence interval, 23.91–16 940;P< 0.0001) was identified as an independent predictor of treatment failure. No serious adverse events were observed with EBR/GZR therapy.ConclusionsThe SVR rate of EBR/GZR would have been 100% in patients without either a history of DAA therapy or double mutation. This combination of drugs could be safely given and is, thus, considered a highly useful first‐line treatment for DAA‐naïve patients with HCV.