在丙型肝炎病毒核糖核酸<600万的初治非肝硬化丙型肝炎1型患者中使用8周的来迪派韦/索磷布韦：单中心、真实世界的有效性和安全性。
Eight-week ledipasvir/sofosbuvir in non-cirrhotic, treatment-naïve hepatitis C genotype-1 patients with hepatitis C virus-RNA < 6 million: Single center, real world effectiveness and safety.
作者信息
Latt Nyan L, Yanny Beshoy T, Gharibian Derenik, Gevorkyan Rita, Sahota Amandeep K
机构信息
Nyan L Latt, Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Mayo Clinic, Jacksonville, FL 32224, United States.
出版信息
World J Gastroenterol. 2017 Jul 14;23(26):4759-4766. doi: 10.3748/wjg.v23.i26.4759.
AIM
To evaluate sustained viral response (SVR) of 8-wk ledipasvir/sofosbuvir therapy among non-cirrhotic, genotype-1 hepatitis C virus (HCV) patients with RNA < 6 million IU/mL.
METHODS
We performed a retrospective cohort study to examine SVR rates, predictors of treatment failure and safety analysis of 8-wk ledipasvir/sofosbuvir (LDV/SOF) therapy among non-cirrhotic, genotype 1 HCV patients with viral load < 6 million IU/mL. Primary outcome was an achievement of SVR at 12 wk after treatment. Secondary outcomes were identifying predictors of treatment failure and adverse events during treatment.
RESULTS
Total 736 patients: 55% males, 51% Caucasians and 65% were genotype 1a. Non-cirrhotic state of 53% was determined by clinical judgment (imaging, AST, platelet count) and 47% had documented liver fibrosis testing (biopsy, vibration-controlled transient elastography, serum biomarkers). Overall SVR12 was 96%. No difference in SVR12 was seen between patients whose non-cirrhotic state was determined by clinical judgment and patients who had fibrosis testing. Age groups, gender, ethnicity and genotype 1 subtype did not predict SVR. Non-cirrhotic state determined by clinical judgment based on simple, non-invasive tests were not associated with lower SVR [OR = 1.02, 95%CI: 0.48-2.17, = 0.962]. The AUROC for hepatitis C RNA viral load was 0.734 ( < 0.001, 95%CI: 0.66-0.82). HCV RNA 2.2 million IU/mL was identified as the cutoff value with sensitivity 73% and specificity 64%. HCV RNA < 2.2 million IU/mL was associated with significantly higher SVR 98% with OR = 0.22 (95%CI: 0.1-0.49, < 0.001) compared to SVR 92% in HCV RNA ≥ 2.2 million IU/mL. No death or morbidities were reported.
CONCLUSION
Our outcomes validate safety and effectiveness of 8-wk LDV/SOF therapy in non-cirrhotic, untreated HCV genotype 1 patients with HCV RNA < 6 million IU/mL.
目的
评估8周的来迪派韦/索磷布韦治疗方案在丙肝病毒（HCV）RNA水平＜600万国际单位/毫升的非肝硬化1型HCV患者中的持续病毒学应答（SVR）情况。
方法
我们开展了一项回顾性队列研究，以检测丙肝病毒RNA水平＜600万国际单位/毫升的非肝硬化1型HCV患者接受8周来迪派韦/索磷布韦（LDV/SOF）治疗后的SVR率、治疗失败的预测因素及安全性分析。主要结局为治疗后12周实现SVR。次要结局为确定治疗失败的预测因素及治疗期间的不良事件。
结果
共736例患者，55%为男性，51%为白种人，65%为1a型基因型。53%的非肝硬化状态由临床判断（影像学、谷草转氨酶、血小板计数）确定，47%有肝纤维化检测记录（活检、振动控制瞬时弹性成像、血清生物标志物）。总体SVR12为96%。临床判断确定非肝硬化状态的患者与进行纤维化检测的患者之间的SVR12无差异。年龄组、性别、种族和1型基因型亚型均不能预测SVR。基于简单非侵入性检测的临床判断确定的非肝硬化状态与较低的SVR无关[比值比（OR）=1.02，95%置信区间（CI）：0.48 - 2.17，P = 0.962]。丙肝病毒RNA病毒载量的曲线下面积（AUROC）为0.734（P＜0.001，95%CI：0.66 - 0.82）。丙肝病毒RNA 220万国际单位/毫升被确定为临界值，敏感性为73%，特异性为64%。与丙肝病毒RNA≥220万国际单位/毫升时SVR为92%相比，丙肝病毒RNA＜220万国际单位/毫升时SVR显著更高，为98%，OR = 0.22（95%CI：0.1 - 0.49，P＜0.001）。未报告死亡或发病情况。
结论
我们的研究结果证实了8周LDV/SOF治疗方案在丙肝病毒RNA＜600万国际单位/毫升的未经治疗的非肝硬化1型HCV患者中的安全性和有效性。
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