Ogawa Eiichi, Furusyo Norihiro, Shimizu Motohiro, Ihara Takeshi, Hayashi Takeo, Harada Yuji, Toyoda Kazuhiro, Murata Masayuki, Hayashi Jun
Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan.
Antivir Ther. 2015;20(2):185-92. doi: 10.3851/IMP2805. Epub 2014 Jun 18.
Liver fibrosis remains one of the most important predictors of sustained virological response (SVR) in this era of direct-acting antiviral treatment of chronic hepatitis C. We compare non-invasive fibrosis assessment with liver biopsy (METAVIR) in terms of their ability to predict SVR by telaprevir (TVR)-based triple therapy.
This prospective study consisted of 108 patients with chronic HCV genotype 1 infection who received TVR in combination with pegylated interferon (PEG-IFN)-α2b and ribavirin (RBV). Non-invasive fibrosis data included transient elastography (FibroScan), FIB-4 index and aspartate aminotransferase to platelet ratio index (APRI).
SVR was achieved by 84.3% of the patients by intention-to-treat analysis. In contrast to the high SVR rates for treatment-naive patients (87.1%, 27 of 31) and patients who previously relapsed (97.9%, 46 of 47), the SVR rate of prior partial/null responders was significantly lower (60.0%, 18 of 30). The impact of fibrosis on SVR was greater for prior partial/null responders, and fibrosis data, including both METAVIR score and non-invasive fibrosis assessments, were useful for predicting SVR. The METAVIR score (area under the receiver operating characteristic curve [AUROC] 0.91, cutoff ≤F2), FibroScan values (AUROC 0.99, cutoff ≤10.0 kPa), FIB-4 index (AUROC 0.91, cutoff ≤3.5) and APRI (AUROC 0.91, cutoff ≤0.80) were shown to have equal, excellent predictive power.
An alternative to METAVIR score by liver biopsy, non-invasive fibrosis assessments are useful options for predicting SVR by prior partial or null responders in TVR-based triple therapy.
在慢性丙型肝炎直接抗病毒治疗的时代,肝纤维化仍然是持续病毒学应答(SVR)的最重要预测指标之一。我们比较了非侵入性纤维化评估与肝活检(METAVIR)在通过基于特拉匹韦(TVR)的三联疗法预测SVR方面的能力。
这项前瞻性研究纳入了108例慢性丙型肝炎基因1型感染患者,他们接受了TVR联合聚乙二醇化干扰素(PEG-IFN)-α2b和利巴韦林(RBV)治疗。非侵入性纤维化数据包括瞬时弹性成像(FibroScan)、FIB-4指数和天冬氨酸转氨酶与血小板比值指数(APRI)。
意向性分析显示84.3%的患者实现了SVR。与初治患者的高SVR率(87.1%,31例中的27例)和既往复发患者(97.9%,47例中的46例)相比,既往部分/无应答者的SVR率显著较低(60.0%,30例中的18例)。纤维化对既往部分/无应答者的SVR影响更大,包括METAVIR评分和非侵入性纤维化评估在内的纤维化数据对预测SVR均有用。METAVIR评分(受试者工作特征曲线下面积[AUROC]为0.91,临界值≤F2)、FibroScan值(AUROC为0.99,临界值≤10.0 kPa)、FIB-4指数(AUROC为0.91,临界值≤3.5)和APRI(AUROC为0.91,临界值≤0.80)均显示出同等出色的预测能力。
作为肝活检METAVIR评分的替代方法,非侵入性纤维化评估是预测既往部分或无应答者在基于TVR的三联疗法中SVR的有用选择。