Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
Hepatol Int. 2021 Apr;15(2):338-349. doi: 10.1007/s12072-021-10158-x. Epub 2021 Mar 6.
Data regarding the real-world effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) for East Asian patients with chronic hepatitis C virus (HCV) infection and compensated liver disease are limited. We evaluated the performance of SOF/VEL for 12 weeks for HCV-infected patients with compensated liver disease in a large real-world cohort in Taiwan.
Between July 2019 and March 2020, 1880 HCV-infected patients with compensated liver disease who received SOF/VEL 400/100 mg once daily for 12 weeks were included at 15 academic centers in Taiwan. The sustained virologic response at off-treatment week 12 (SVR) was assessed for evaluable (EP) and per-protocol populations (PP). The tolerance was also reported.
The SVR rates by EP and PP analyses were 95.6% [1798 of 1880 patients; 95% confidence interval (CI) 94.6-96.5%] and 99.3% (1798 of 1811 patients; 95% CI 98.8-99.6%), respectively. Among 82 patients who failed to achieve SVR, 13 (15.9%) were attributed to virologic failures. The SVR rates were comparable regardless of baseline characteristics. A total of 1859 (98.9%) patients completed 12-week SOF/VEL treatment. Four (0.2%) patients discontinued treatment due to adverse events (AEs). All patients with serious AEs or deaths were judged not related to SOF/VEL. The AEs occurring in ≥ 10% included headache (16.8%), fatigue (16.2%), nausea (11.8%), and insomnia (11.1%). Nine (0.5%) and 2 (0.1%) patients had grade 3 total bilirubin and alanine aminotransferase elevations.
SOF/VEL for 12 weeks is efficacious and well-tolerated by chronic HCV-infected patients with compensated liver disease in Taiwan.
有关索磷布韦/维帕他韦（SOF/VEL）在东亚慢性丙型肝炎病毒（HCV）感染合并代偿性肝病患者中的真实世界疗效和安全性的数据有限。我们评估了 SOF/VEL 在台湾的一个大型真实世界队列中对 12 周 HCV 感染合并代偿性肝病患者的疗效。
2019 年 7 月至 2020 年 3 月，在台湾的 15 个学术中心共纳入了 1880 例接受 SOF/VEL 400/100mg 每日一次治疗 12 周的 HCV 感染合并代偿性肝病患者。通过可评估（EP）和符合方案（PP）人群评估治疗结束后第 12 周的持续病毒学应答（SVR）。同时报告了药物耐受性。
EP 和 PP 分析的 SVR 率分别为 95.6%（1798/1880 例患者；95%置信区间[CI] 94.6-96.5%）和 99.3%（1798/1811 例患者；95%CI 98.8-99.6%）。在 82 例未达到 SVR 的患者中，13 例（15.9%）归因于病毒学失败。无论基线特征如何，SVR 率均相似。共有 1859 例（98.9%）患者完成了 12 周的 SOF/VEL 治疗。4 例（0.2%）患者因不良事件（AE）而停药。所有发生严重 AE 或死亡的患者均被判定与 SOF/VEL 无关。发生率≥10%的 AE 包括头痛（16.8%）、疲劳（16.2%）、恶心（11.8%）和失眠（11.1%）。9 例（0.5%）和 2 例（0.1%）患者出现 3 级总胆红素和丙氨酸氨基转移酶升高。
SOF/VEL 治疗 12 周对台湾慢性 HCV 感染合并代偿性肝病患者是有效且耐受良好的。
