目的：Elbasvir/grazoprevir (EBR/GZR) 為新一代固定劑量複方之抗C 型肝炎病毒(hepatitis C virus, HCV) 藥物，核准用於治療慢性HCV 基因第1 型或第4 型 (genotype 1, [GT1] 或genotype 4 [GT4]) 感染。本研究擬探討某醫學中心執行中央健康保險署(National Health Insurance, NHI)「C 型肝炎全口服新藥健保給付執行計畫」，針對GT1 病人EBR/GZR 的照護合理性、安全性與療效評估。
方法：本研究為回溯性觀察研究，利用醫學研究資料庫篩選出2017 年6 月至2018 年4 月使用EBR/GZR 治療HCV GT1 病人，分析病人年齡、性別、HCV 量、血清生化監測、副作用及停藥後持續病毒學反應 (sustained virological response, SVR) 等照護合理性、安全性與療效評估。
結果：本研究收納164 位使用EBR/GZR 慢性C 型肝炎病人，160 人 (97.6%) 為HCV GT1b，31 位 (18.9%) 曾接受干擾素 (pegylated interferon alfa, Peg-IFN) 治療失敗，96 位 (58.5%) 治療前HCV 核糖核酸 (ribonucleic acid, RNA) ≥ 800,000 IU/mL。以治療前HCV RNA 病毒量 (≥ 或 < 800,000 IU/mL) 作為分組探討，高病毒量組曾接受Peg-IFN 的比例較高 (24.0% vs. 11.8%, p = 0.049)。有遵循「治療初始8 週，宜每次處方2週」治療建議者，副作用的發生件數為35 件，未遵循者為17 件 (p = 0.257)，遵循者與不遵循者重度副作用發生比例分別為3% 與0% (p = 0.162)。療效分析結果，停藥後12 週持續病毒學反應 (SVR12) 高達98.2%。SVR12 相關因子分析以HCV GT1b、無肝癌病史者達成SVR12 比例顯著較高。
結論：EBR/GZR 用於治療HCV GT1 病人的整體臨床療效佳。遵循治療建議回診是必要的，可及早發現副作用並給予適當處置。

Objective: Elbasvir/grazoprevir (EBR/GZR) is a fixed-dose combination antiviral drug used to treat chronic hepatitis C virus (HCV) genotype (GT) 1 or 4 infection. This study aimed to evaluate the clinical effectiveness, safety, and appropriateness of care for patients with HCV GT1 undergoing antiviral therapy according to the National Health Insurance (NHI) program.
Methods: We conducted a retrospective observational study of patients with HCV GT1 receiving EBR/GZR treatment between June 2017 and April 2018. Appropriateness, safety, and efficacy were evaluated according to age, sex, HCV ribonucleic acid (RNA) level, serum biochemistry, side effects, and sustained virologic response at 12 weeks (SVR12).
Results: Among the 164 enrolled patients, 97.6% had HCV GT1b, 18.9% had treatment failure with pegylated interferon alfa (Peg-IFN), and 58.5% had a baseline HCV RNA level more than 800,000 IU/mL before treatment. Peg-IFN treatment failure was high in the high HCV RNA viral load group (24.0% vs 11.8%, p = 0.049). According to the NHI program, drugs were prescribed and side effects were evaluated every 2 weeks for the first 8 weeks of treatment. During the regular follow-up, 35 EBR/GZRrelated adverse events (p = 0.257) were noted, with 3% of patients having severe side effects (p = 0.162). The therapeutic effect had an SVR12 of 98.2%. The achieved SVR12 was significantly associated with HCV GT1b and had no history of hepatocellular carcinoma.
Conclusions: EBR/GZR exhibited an excellent overall clinical efficacy for the treatment of patients with HCV GT1. Regular follow-up is necessary for side effect evaluation and appropriate management.


Summited for publication: 2019.10.22; Accepted for publication: 2020.2.22