索磷布韦/维帕他韦在台湾的真实世界环境中对丙型肝炎合并晚期纤维化或肝硬化患者有效。
Sofosbuvir/velpatasvir is an effective treatment for patients with hepatitis C and advanced fibrosis or cirrhosis in a real-world setting in Taiwan.
机构信息
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chang Gung Memorial Hospital, No. 6, Section West, Chiapu Road, Puzi, Chiayi, 613, Taiwan.
College of Medicine, Chang Gung University, Taoyuan, Taiwan.
出版信息
BMC Gastroenterol. 2021 Jun 12;21(1):259. doi: 10.1186/s12876-021-01837-y.
INTRODUCTION
Real-world data regarding the impact of hepatic fibrosis on the effectiveness of sofosbuvir/velpatasvir (SOF/VEL) treatment is limited in the Asian population.
METHODS
We analyzed data for all 823 patients with hepatitis C virus treated with SOF/VEL from June 2019 to September 2020 at Chang Gung Memorial Hospital in Chiayi, Taiwan. The degree of fibrosis was determined using the fibrosis-4 (FIB-4) index, with advanced fibrosis or cirrhosis defined as a FIB-4 score of > 3.25. The primary treatment outcome was the rate of sustained virologic response 12 weeks after treatment cessation (SVR). Adverse events (AEs) were also evaluated.
RESULTS
SVR rates did not significantly differ (p > 0.05) between patients with FIB-4 scores of ≤ 3.25 and those with scores of > 3.25. In the per protocol analysis, 99.2% (593/598) of the FIB-4 ≤ 3.25 group and 100% (172/172) of the FIB-4 > 3.25 group achieved SVR; in the evaluable population analysis, 93.4% (593/635) of the FIB-4 ≤ 3.25 group and 91.5% (172/188) of the FIB-4 > 3.25 group achieved SVR. Five patients with FIB-4 scores of ≤ 3.25 did not attain SVR: two relapsed and three had no response. The most common AEs were comparable (p > 0.05) for the FIB-4 ≤ 3.25 group and the FIB-4 > 3.25 group and included abdominal discomfort (4.4% vs. 5.9%), fatigue (4.1% vs. 5.9%), and skin itching (3.6% vs. 3.2%). Laboratory abnormalities were more common in the FIB-4 > 3.25 group (p < 0.001). Six patients with FIB-4 scores of > 3.25 had total bilirubin elevation > 3 × the upper normal limit (UNL). Alanine transaminase elevation > 5 × the UNL was observed in two patients with FIB-4 scores of ≤ 3.25 and one patient with a FIB-4 score of > 3.25. No AEs resulted in treatment discontinuation.
CONCLUSIONS
SOF/VEL treatment is well tolerated and achieves high SVR rates for patients of Taiwanese ethnicity with HCV, regardless of cirrhosis status.
简介
关于肝纤维化对索磷布韦/维帕他韦（SOF/VEL）治疗效果影响的真实世界数据在亚洲人群中较为有限。
方法
我们分析了 2019 年 6 月至 2020 年 9 月在台湾嘉义长庚纪念医院接受 SOF/VEL 治疗的 823 例丙型肝炎病毒患者的数据。纤维化程度采用纤维化 4 指数（FIB-4）确定，纤维化-4 评分（FIB-4）>3.25 定义为晚期纤维化或肝硬化。主要治疗结局为治疗结束后 12 周持续病毒学应答率（SVR）。还评估了不良反应（AE）。
结果
FIB-4 评分≤3.25 组与评分>3.25 组的 SVR 率无显著差异（p>0.05）。在方案分析中，FIB-4≤3.25 组的 99.2%（593/598）和 FIB-4>3.25 组的 100%（172/172）达到 SVR；在可评估人群分析中，FIB-4≤3.25 组的 93.4%（593/635）和 FIB-4>3.25 组的 91.5%（172/188）达到 SVR。5 例 FIB-4 评分≤3.25 患者未达到 SVR：2 例复发，3 例无应答。最常见的 AE 在 FIB-4≤3.25 组和 FIB-4>3.25 组之间无差异（p>0.05），包括腹部不适（4.4% vs. 5.9%）、疲劳（4.1% vs. 5.9%）和皮肤瘙痒（3.6% vs. 3.2%）。FIB-4>3.25 组的实验室异常更常见（p<0.001）。6 例 FIB-4>3.25 患者的总胆红素升高超过正常上限（UNL）的 3 倍。2 例 FIB-4≤3.25 和 1 例 FIB-4>3.25 的患者丙氨酸氨基转移酶升高超过 UNL 的 5 倍。没有因 AE 而导致治疗中断。
结论
SOF/VEL 治疗对台湾 HCV 患者耐受性良好，无论肝硬化状态如何，均可获得较高的 SVR 率。
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