台灣某區域醫院Zepatier藥品使用評估

Drug utilization evaluation of Zepatier in regional hospitals in Taiwan

劉鳳樟(Fon-Chang Liu) ； 賴冠名(Kuan-Ming Lai) ； 李瑞珍(Jui-Chen Lee)

《安泰醫護雜誌》 26卷2期 (2020/12) Pp. 77-83

摘要

前言：在台灣C型肝炎的盛行率約為2-5%。C型肝炎治療目前以pegylated interferon與ribavirin的合併使用為主，Zepatier（Elbasvir+Grazoprevir）對慢性C型肝炎病患的實際療效與藥物使用評估的數據是有限的。目的：我們旨在評估在HCV患者中Zepatier的臨床表現。方法：:研究納入16例接受Zepatier治療慢性C肝炎或HCV相關性肝硬化代償性患者。比較Zepatier治療之前（基線）及8周治療結束（End of treatment, EOT）與8周治療結束後12週（Follow-up 12）持久性病毒反應（Sustained virologic response，SVR_(12)）和血液生化檢查。藉此研究SVR_(12)和生化檢查隨治療時間的變化。結果：患者於基線和EOT之間（p＜0.05）以及EOT和治療結束後的12週（p＜0.01）之間的GOT和GPT含量存在顯著差異。在基線和EOT治療結束後的12週，血清白蛋白水平發現顯著升高（p＜0.01）。而接受8周治療的患者的總體SVR率為100％。但在基線和Follow-up 12之間則總膽紅素（Total bilirubin）顯著減少（p＜0.05）。結語：慢性HCV患者接受八周Zepatier治療具有良好耐受性及導致較高的SVR_(12)。

關鍵字

C型肝炎 ； 直接作用抗病毒藥物 ； 持久性病毒反應 ； 直接膽紅素

並列摘要

Background: The prevalence of chronic hepatitis C is 2% to 5% in Taiwan. The optimal therapeutic regimen for hepatitis C is pegylated interferon in combination with ribavirin. The data regarding the real-world effectiveness and drug use evaluation of Zepatier (Elbasvir+Grazoprevir) for patients with chronic hepatitis C virus (HCV) infection were limited in Taiwan. Objective: We aimed to evaluate the clinical performance of Zepatier in HCV patient. Methods: 16 patients with chronic hepatitis C or HCV-related compensated cirrhosis who were treated with Zepatier were included in the study. Sustained virologic response at 12 weeks after the end of therapy (SVR_(12)) and the biochemical examinations were measured before Zepatier treatment (Baseline), at the end of treatment (EOT, 8weeks), and at 12 weeks after EOT (Follow-up 12). The changes over time in the SVR_(12) and biochemical examinations were investigated. Results: The study included differences in GOT and GPT levels were seen between Baseline and EOT ( p ＜ 0.01) and between EOT and Follow-up 12 ( p ＜ 0.01). There was significant difference in serum albumin levels in Baseline and Follow-up 12 ( p ＜0.01). Moreover, the overall SVR rate was 100% in patients receiving 8 weeks of treatment. The SVR_(12) rates were comparable regardless of baseline characteristics or week 8 and Follow-up 12 viral decline. But a significant decrease in Total bilirubin was seen between Baseline and Follow-up 12 ( p ＜ 0.05). Conclusion: Eight-week Zepatier was well tolerated and led to a high SVR_(12) rate in treatment patients with chronic HCV infection.

並列關鍵字

Hepatitis C ； Direct-acting antiviral ； Sustained virologic response ； Direct bilirubin