Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chi Mei Medical Center, Yongkang District, Tainan, Taiwan.
Sci Rep. 2021 Dec 6;11(1):23473. doi: 10.1038/s41598-021-03006-3.
The study evaluated the real-world treatment outcomes of Glecaprevir/pibrentasvir (GLE/PIB) including effectiveness, safety and healthcare resource utilization based on a nation-wide registry in Taiwan. The Taiwan HCV Registry (TACR) is a nation-wide platform organized and supervised by the Taiwan Association for the Study of the Liver. Data were analyzed for patients treated with GLE/PIB, including 3144 patients who had treatment outcome available. The primary endpoint was sustained virological response (SVR12, undetectable HCV RNA throughout 12 weeks of end-of-treatment). The overall SVR12 rate was 98.9% (3110/3144), with 98.8%, 99.4% and 100% in patients receiving 8 weeks, 12 weeks, and 16 weeks of GLE/PIB respectively. The SVR12 rate in the treatment-naïve cirrhotic patients receiving 8 weeks of GLE/PIB was 98.2% (108/110). The most common AEs were fatigue (7.5%), pruritus (6.7%) and dizziness (1.5%). The mean number of outpatient visits during the GLE/PIB was 5.94 visits for patients treated with 8 weeks, significantly different from the patients treated with 12 weeks of GLE/PIB (6.90 visits). The results support the effectiveness and safety of GLE/PIB treatment in real-world clinical practice, and provide further evidence that the shorter, 8-week GLE/PIB regimen is effective and cost-saving.
本研究基于台湾的全国性注册中心，评估了 Glecaprevir/pibrentasvir（GLE/PIB）的真实世界治疗结局，包括疗效、安全性和医疗资源利用情况。台湾丙型肝炎注册中心（TACR）是一个由台湾肝病研究学会组织和监管的全国性平台。对接受 GLE/PIB 治疗的患者进行了数据分析，其中 3144 例患者具有治疗结局。主要终点是持续病毒学应答（SVR12，治疗结束后 12 周内 HCV RNA 不可检测）。总体 SVR12 率为 98.9%（3110/3144），接受 8 周、12 周和 16 周 GLE/PIB 治疗的患者分别为 98.8%、99.4%和 100%。接受 8 周 GLE/PIB 治疗的无肝硬化初治患者的 SVR12 率为 98.2%（108/110）。最常见的不良反应是疲劳（7.5%）、瘙痒（6.7%）和头晕（1.5%）。接受 8 周 GLE/PIB 治疗的患者在 GLE/PIB 治疗期间的平均门诊就诊次数为 5.94 次，明显低于接受 12 周 GLE/PIB 治疗的患者（6.90 次）。结果支持 GLE/PIB 治疗在真实世界临床实践中的有效性和安全性，并进一步证明了较短的 8 周 GLE/PIB 方案是有效且节省成本的。
