Comparison of Glecaprevir/Pibrentasvir and Sofosbuvir/Ledipasvir in Patients with Hepatitis C Virus Genotype 1 and 2 in South Korea.

Hyun Deok Shin, Il Han Song, Sae Hwan Lee, Hong Soo Kim, Tae Hee Lee, Hyuk Soo Eun, Seok Hyun Kim, Byung Seok Lee, Hee Bok Chae, Seok Hwan Kim, Myung Joon Song, Soon Yeong Ko, Suk Bae Kim
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Abstract

Background/aims: This study compared the effectiveness and safety of glecaprevir/pibrentasvir (GLE/PIB) and sofosbuvir/ledipasvir (SOF/LDV) in real-life clinical practice.

Methods: The data from genotype 1 or 2 chronic hepatitis C patients treated with GLE/PIB or sofosbuvir + ribavirin or SOF/LDV in South Korea were collected retrospectively. The analysis included the treatment completion rate, sustained virologic response at 12 weeks (SVR12) test rate, treatment effectiveness, and adverse events.

Results: Seven hundred and eighty-two patients with genotype 1 or 2 chronic hepatitis C who were treated with GLE/PIB (n=575) or SOF/LDV (n=207) were included in this retrospective study. The baseline demographic and clinical characteristics revealed significant statistical differences in age, genotype, ascites, liver cirrhosis, and hepatocellular carcinoma between the GLE/PIB and SOF/LDV groups. Twenty-two patients did not complete the treatment protocol. The treatment completion rate was high for both regimens without statistical significance (97.7% vs. 95.7%, p=0.08). The overall SVR12 of intention-to-treat analysis was 81.2% vs. 80.7% without statistical significance (p=0.87). The overall SVR12 of per protocol analysis was 98.7% vs. 100% without statistical significance (p=0.14). Six patients treated with GLE/PIB experienced treatment failure. They were all male, genotype 2, and showed a negative hepatitis C virus RNA level at the end of treatment. Two patients treated with GLE/PIB stopped medication because of fever and abdominal discomfort.

Conclusions: Both regimens had similar treatment completion rates, effectiveness, and safety profiles. Therefore, the SOF/LDV regimen can also be considered a viable DAA for the treatment of patients with genotype 1 or 2 chronic hepatitis C.

Glecaprevir/Pibrentasvir 和 Sofosbuvir/Ledipasvir 在韩国丙型肝炎病毒基因 1 型和 2 型患者中的疗效比较。
背景/目的:本研究比较了格列卡韦/匹布伦达韦(GLE/PIB)和索非布韦/雷迪帕韦(SOF/LDV)在实际临床实践中的有效性和安全性:回顾性收集了韩国接受GLE/PIB或索非布韦+利巴韦林或SOF/LDV治疗的基因1型或2型慢性丙型肝炎患者的数据。分析包括治疗完成率、12周持续病毒学应答(SVR12)检测率、治疗效果和不良事件:这项回顾性研究共纳入 782 名基因型 1 或 2 慢性丙型肝炎患者,他们接受了 GLE/PIB (575 人)或 SOF/LDV (207 人)治疗。基线人口统计学和临床特征显示,GLE/PIB 组和 SOF/LDV 组在年龄、基因型、腹水、肝硬化和肝细胞癌方面存在显著的统计学差异。22名患者未完成治疗方案。两种方案的治疗完成率都很高(97.7% 对 95.7%,P=0.08),但无统计学意义。意向治疗分析的总体 SVR12 为 81.2% 对 80.7%,无统计学意义(P=0.87)。按方案分析的总 SVR12 为 98.7% 对 100%,无统计学意义(P=0.14)。六名接受 GLE/PIB 治疗的患者出现了治疗失败。他们均为男性,基因型为 2 型,治疗结束时丙型肝炎病毒 RNA 水平为阴性。两名接受 GLE/PIB 治疗的患者因发热和腹部不适而停药:结论:两种治疗方案的治疗完成率、有效性和安全性相似。因此,SOF/LDV 方案也可被视为治疗基因型 1 或 2 慢性丙型肝炎患者的一种可行的 DAA 方案。
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