Seo Kayo, Kim Soo Ki, Kim Soo Ryang, Ohtani Aya, Kobayashi Mana, Kato Airi, Morimoto Eri, Saijo Yuka, Kim Ke Ih, Imoto Susumu, Kim Chi Wan, Yano Yoshihiko, Kudo Masatoshi, Hayashi Yoshitake
Division of Molecular Medicine and Medical Genetics, Department of Pathology, Kobe University Graduate School of Medicine, Kobe, Japan.
Dig Dis. 2017;35(6):541-547. doi: 10.1159/000480145. Epub 2017 Oct 17.
Sofosbuvir plus ribavirin (RBV) therapy showed higher sustained virological response at 12 weeks after treatment (SVR12) than pegylated interferon (peg-IFN) plus RBV; however, liver function, fibrosis, and hepatocellular carcinoma markers have not been assessed so far.
Patients (n = 21) receiving Sofosbuvir plus RBV and those (n = 24) receiving peg-IFN plus RBV were enrolled in this study. Changes in alanine aminotransferase (ALT) and α-fetoprotein (AFP) levels, platelet (PLT) counts, FIB-4, and aspartate aminotransferase-to-platelet ratio index (APRI) in both groups were assessed in patients achieving SVR12. Also, fibrosis regression was assessed using pathophysiological biomarkers, such as hyaluronic acid, bone morphogenetic protein 7 (BMP-7), and connective tissue growth factor (CTGF) in the Sofosbuvir plus RBV group. In both groups, while the reduction in ALT levels was significant that of AFP was not. Compared with the baseline, although serum PLT count at the end of treatment (EOT) was significantly higher in the Sofosbuvir plus RBV group, it was significantly lower in the peg-IFN plus RBV group. Although a significant decline in fibrosis markers such as FIB-4 and APRI was observed between the baseline and at EOT in the Sofosbuvir plus RBV group, no significant change of these markers was observed in the peg-IFN plus RBV group. Moreover, BMP-7 and CTGF were significantly lower at EOT than the baseline in the Sofosbuvir plus RBV group. Key Message: The treatment with Sofosbuvir plus RBV results in not only a higher SVR, but also improves the liver function and the degree of fibrosis.
索磷布韦联合利巴韦林（RBV）治疗在治疗后12周时显示出比聚乙二醇干扰素（peg-IFN）联合RBV更高的持续病毒学应答（SVR12）；然而，迄今为止尚未评估肝功能、纤维化和肝细胞癌标志物。
本研究纳入了接受索磷布韦联合RBV治疗的患者（n = 21）和接受peg-IFN联合RBV治疗的患者（n = 24）。对达到SVR12的两组患者的丙氨酸氨基转移酶（ALT）和甲胎蛋白（AFP）水平、血小板（PLT）计数、FIB-4以及天冬氨酸氨基转移酶与血小板比值指数（APRI）的变化进行了评估。此外，在索磷布韦联合RBV组中，使用病理生理生物标志物如透明质酸、骨形态发生蛋白7（BMP-7）和结缔组织生长因子（CTGF）评估纤维化消退情况。在两组中，虽然ALT水平的降低显著，但AFP水平的降低不显著。与基线相比，虽然索磷布韦联合RBV组治疗结束时（EOT）的血清PLT计数显著更高，但peg-IFN联合RBV组显著更低。虽然在索磷布韦联合RBV组中，基线与EOT之间观察到FIB-4和APRI等纤维化标志物显著下降，但在peg-IFN联合RBV组中未观察到这些标志物的显著变化。此外，在索磷布韦联合RBV组中，EOT时BMP-7和CTGF显著低于基线。关键信息：索磷布韦联合RBV治疗不仅导致更高的SVR，还改善了肝功能和纤维化程度。
