Department of Hepatology, Iizuka Hospital, Iizuka, Fukuoka 820-8505, Japan.
World J Gastroenterol. 2018 Apr 7;24(13):1478-1485. doi: 10.3748/wjg.v24.i13.1478.
To investigate the real-world efficacy and safety of sofosbuvir/ribavirin (SOF/RBV) therapy for Japanese patients with genotype 2 hepatitis C virus (GT2-HCV).
A total of 182 patients with GT2-HCV infection who received SOF/RBV therapy for 12 wk at our hospital were enrolled. The patients comprised 122 men and 60 women (age range: 17-84 years; mean age ± SD: 60.1 ± 12.1 years). Relationships between virological response and clinical data were examined by logistic regression analyses.
The proportions of patients with liver cirrhosis and history of hepatocellular carcinoma (HCC) were 29.0% and 17.3%, respectively. The proportion of patients with prior interferon (IFN)-based therapy was 25.6%. SOF/RBV therapy rapidly decreased HCV RNA levels. Several patients required RBV dose reduction because of anemia or fatigue. Four patients discontinued the therapy. The rates of sustained virological response at 12 wk after the end of treatment were 87.9% (intention to treat: 160/182) and 94.1% (per protocol: 159/169). Multivariate analyses showed that history of HCC or IFN-based therapy independently reduced the efficacy of SOF/RBV therapy.
SOF/RBV therapy for GT2-HCV is safe, highly tolerated, and effective. History of HCC or IFN-based therapy independently reduces the efficacy of this treatment.
研究索磷布韦/利巴韦林(SOF/RBV)治疗日本基因型 2 丙型肝炎病毒(GT2-HCV)患者的真实世界疗效和安全性。
本研究共纳入 182 例在我院接受 SOF/RBV 治疗 12 周的 GT2-HCV 感染患者。患者包括 122 名男性和 60 名女性(年龄范围:17-84 岁;平均年龄±标准差:60.1±12.1 岁)。通过逻辑回归分析检查病毒学应答与临床数据之间的关系。
肝硬化和肝细胞癌(HCC)病史患者分别占 29.0%和 17.3%。既往接受过干扰素(IFN)治疗的患者比例为 25.6%。SOF/RBV 治疗可迅速降低 HCV RNA 水平。由于贫血或疲劳,有几位患者需要减少 RBV 剂量。有 4 名患者停止了治疗。治疗结束后 12 周的持续病毒学应答率为 87.9%(意向治疗:160/182)和 94.1%(符合方案:159/169)。多变量分析表明,HCC 病史或 IFN 治疗史独立降低了 SOF/RBV 治疗的疗效。
SOF/RBV 治疗 GT2-HCV 安全、耐受性好、疗效高。HCC 病史或 IFN 治疗史独立降低了该治疗的疗效。