Effectiveness of Glecaprevir/Pibrentasvir for Hepatitis C: Real-World Experience and Clinical Features of Retreatment Cases
Effectiveness of Glecaprevir/Pibrentasvir for Hepatitis C: Real-World Experience and Clinical Features of Retreatment Cases
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DOI：
10.3390/biomedicines8040074
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发表时间：
2020-04-01
期刊：
影响因子：
4.7
通讯作者：
Umemura, Takeji
中科院分区：
文献类型：
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作者：
Sugiura, Ayumi;Joshita, Satoru;Umemura, Takeji
Glecaprevir/pibrentasvir (G/P) 是直接作用抗病毒药物 (DAA)，可对丙型肝炎病毒 (HCV) 感染实现较高的持续病毒学应答 (SVR) 率。我们根据现实经验和再治疗病例的临床特征研究了 G/P 对 HCV 患者的有效性。对首次治疗 (n = 159) 和再治疗 (n = 23) G/P 组之间的 HCV 患者 (n = 182) 的临床特征和结果进行了比较。总体而言，77例患者（42.3%）为男性，中位年龄为68岁，基因型1/2/1 + 2/3分别为86/66/1/4例。根据意向治疗分析，97.8% (178/182) 的病例实现了 SVR，根据方案分析，99.4% (178/179) 的病例实现了 SVR。首次治疗组和再治疗组之间的男性（42.8% vs. 39.1%，p = 0.70）、中位年龄（68 vs. 68 岁，p = 0.36）、既往肝细胞癌（5.8% vs. 8.7%，p = 0.59）或纤维化标志物 AST 与血小板比率指数（APRI）（0.5 vs. 0.59）之间没有显着差异。 0.5，p = 0.80）和纤维化 4 (FIB-4) 指数（2.2 与 2.6，p = 0.59）。再治疗组的干扰素治疗史（12.3% vs. 52.2%，p < 0.01）和 Y93H 突变（25.0% vs. 64.7%，p = 0.02）明显更频繁。经历过 3 次、2 次和 1 次 DAA 治疗失败的再治疗患者人数分别为 1 例、3 例和 19 例，所有这些患者最终均通过 G/P 治疗实现了 SVR。总之，尽管再治疗组对其他既往 DAA 具有特异性耐药突变，但 G/P 对于 HCV 首次治疗和再治疗病例均有效且安全。由于 P32 缺失导致 G/P 治疗失败的报道，临床医生应在 DAA 选择过程中考虑耐药突变。
Glecaprevir/pibrentasvir (G/P) are direct-acting antivirals (DAAs) that achieve a high sustained virological response (SVR) rate for hepatitis C virus (HCV) infection. We investigated G/P effectiveness for HCV patients based on real-world experience and the clinical features of retreatment cases. HCV patients (n = 182) were compared for clinical features and outcomes between first treatment (n = 159) and retreatment (n = 23) G/P groups. Overall, 77 patients (42.3%) were male, the median age was 68 years, and 86/66/1/4 cases had genotype 1/2/1 + 2/3, respectively. An SVR was achieved in 97.8% (178/182) of cases by intention-to-treat analysis and 99.4% (178/179) of cases by per-protocol analysis. There were no remarkable differences between the first treatment and retreatment groups for male (42.8% vs. 39.1%, p = 0.70), median age (68 vs. 68 years, p = 0.36), prior hepatocellular carcinoma (5.8% vs. 8.7%, p = 0.59), or the fibrosis markers AST-to-platelet ratio index (APRI) (0.5 vs. 0.5, p = 0.80) and fibrosis-4 (FIB-4) index (2.2 vs. 2.6, p = 0.59). The retreatment group had a significantly more frequent history of interferon treatment (12.3% vs. 52.2%, p < 0.01) and the Y93H mutation (25.0% vs. 64.7%, p = 0.02). The number of retreatment patients who had experienced 3, 2, and 1 DAA treatment failures was 1, 3, and 19, respectively, all of whom ultimately achieved an SVR by G/P treatment. In conclusion, G/P was effective and safe for both HCV first treatment and retreatment cases despite the retreatment group having specific resistance mutations for other prior DAAs. As G/P treatment failure has been reported for P32 deletions, clinicians should consider resistance mutations during DAA selection.