真实世界中直接作用抗病毒药物在慢性丙型肝炎病毒 2 型感染患者中的疗效和安全性：韩国多中心研究。
Real-world Effectiveness and Safety of Direct-acting Antiviral Agents in Patients with Chronic Hepatitis C Genotype 2 Infection: Korean Multicenter Study.
机构信息
Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.
Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, Korea.
出版信息
J Korean Med Sci. 2021 May 31;36(21):e142. doi: 10.3346/jkms.2021.36.e142.
BACKGROUND
The advancement of treatment with direct-acting antiviral (DAA) agents has improved the cure rate of hepatitis C virus (HCV) infection close to 100%. The aim of our study was to assess the real-world effectiveness and safety of DAA regimens for the treatment of patients with chronic HCV genotype 2.
METHODS
We retrospectively analyzed the clinical data of patients treated with sofosbuvir plus ribavirin (SOF + RBV) or glecaprevir/pibrentasvir (G/P) for chronic HCV genotype 2 infection at seven university hospitals in the Korean southeast region.
RESULTS
SOF + RBV therapy produced an 89% and 98.3% sustained virologic response 12 week (SVR12) after treatment completion in the full analysis set and per-protocol set, respectively, and the corresponding values for G/P therapy were 89.5% and 99.2%, respectively. The difference between the treatments was probably because 6.2% (59/953) of patients in the SOF + RBV group did not complete the treatment and 9.8% (14/143) in the G/P group did not test HCV RNA after treatment completion. Adverse events (A/Es) were reported in 59.7% (569/953) and 25.9% (37/143) of the SOF + RBV and G/P groups, respectively. In the SOF + RBV group, 12 (1.26%) patients discontinued treatment owing to A/Es, whereas no patients discontinued treatment because of A/Es in the G/P group.
CONCLUSION
In both treatment groups, SVR was high when treatment was completed. However, there was a high dropout rate in the SOF + RBV group, and the dropout analysis showed that these were patients with liver cirrhosis (LC; 43/285, 15.1%), especially those with decompensated LC (12/32, 37.5%). Therefore, an early initiation of antiviral therapy is recommended for a successful outcome before liver function declines. Furthermore, patients with decompensated LC who are considered candidates for SOF + RBV treatment should be carefully monitored to ensure that their treatment is completed, especially those with low hemoglobin and high alanine transaminase.
背景
直接作用抗病毒（DAA）药物治疗的进步使丙型肝炎病毒（HCV）感染的治愈率接近 100%。我们的研究旨在评估 DAA 方案治疗慢性 HCV 基因型 2 患者的真实世界疗效和安全性。
方法
我们回顾性分析了韩国东南部 7 所大学医院接受索磷布韦联合利巴韦林（SOF + RBV）或格卡瑞韦/哌仑他韦（G/P）治疗的慢性 HCV 基因型 2 感染患者的临床数据。
结果
SOF + RBV 治疗在全分析集和方案集的治疗完成后 12 周（SVR12）分别产生了 89%和 98.3%的持续病毒学应答，而 G/P 治疗的相应值分别为 89.5%和 99.2%。治疗之间的差异可能是因为 SOF + RBV 组中有 6.2%（59/953）的患者未完成治疗，而 G/P 组中有 9.8%（14/143）的患者在治疗完成后未检测 HCV RNA。SOF + RBV 组和 G/P 组分别有 59.7%（569/953）和 25.9%（37/143）的患者报告了不良事件（AEs）。在 SOF + RBV 组中，有 12 名（1.26%）患者因 AEs 而停止治疗，而 G/P 组中没有患者因 AEs 而停止治疗。
结论
在两组治疗中，完成治疗后 SVR 均较高。然而，SOF + RBV 组的脱落率较高，脱落分析显示这些脱落患者为肝硬化（LC；43/285，15.1%）患者，尤其是失代偿性 LC 患者（12/32，37.5%）。因此，建议在肝功能下降之前尽早开始抗病毒治疗，以获得成功的结果。此外，对于考虑接受 SOF + RBV 治疗的失代偿性 LC 患者，应密切监测以确保其完成治疗，特别是那些血红蛋白低和丙氨酸转氨酶高的患者。
Zotero 插件