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索磷布韦联合利巴韦林治疗丙型肝炎基因型 2 患者:一项真实世界、单中心研究。

Combination treatment with sofosbuvir and ribavirin for patients diagnosed with hepatitis C genotype 2: A real-world, single-center study.

机构信息

Department of Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, South Korea.

Department of Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, South Korea.

出版信息

Arab J Gastroenterol. 2021 Mar;22(1):23-27. doi: 10.1016/j.ajg.2020.09.001. Epub 2020 Nov 19.

Abstract

BACKGROUND AND STUDY AIMS

The demand for treatments for viral hepatitis using direct antiviral agents (DAAs) has increased; however, few real-world clinical studies are available. The objective of this study was to evaluate the efficacy and safety of sofosbuvir combined with ribavirin for patients with chronic hepatitis C (CHC) genotype 2 (GT2).

PATIENTS AND METHODS

A total of 106 consecutive CHC GT2 patients treated with sofosbuvir plus ribavirin between May 2016 and August 2018 (median age: 52.5 years, male: 51 [48.1%], treatment-naïve patients: 98 [92.5%]) were analyzed. The primary endpoint was sustained virologic response at 12 weeks (SVR12). The secondary endpoint was the occurrence of side effects during treatment.

RESULTS

Of a total of 106 patients with CHC GT2, 103 were genotype 2a (97.2%), and 3 were 2b (2.8%). SVR12 was confirmed in 105 of 106 patients (99.1%). The one patient with treatment failure had combined liver cirrhosis and hepatocellular carcinoma. Twenty-five patients had liver cirrhosis in addition to hepatitis C virus (HCV) (Child-Turcotte-Pugh (CTP)-A, n = 24; C, n = 1), and SVR12 was confirmed in 24 of these patients (96.0%). The mean HCV RNA titer was 2,629,159 IU/ml. Reductions in haemoglobin levels occurred in 23 patients during treatment (3.0 mg/dL, mean), and consequently, ribavirin dose reduction was required (365.2 mg, mean).

CONCLUSION

Sofosbuvir plus ribavirin was highly effective for the treatment of patients with CHC GT2 and had no serious, treatment-related adverse effects.

摘要

背景和研究目的

对使用直接抗病毒药物(DAA)治疗病毒性肝炎的需求增加;然而,可用的真实世界临床研究很少。本研究的目的是评估索非布韦联合利巴韦林治疗慢性丙型肝炎(CHC)基因型 2(GT2)患者的疗效和安全性。

患者和方法

分析了 2016 年 5 月至 2018 年 8 月期间接受索非布韦联合利巴韦林治疗的 106 例连续 CHC GT2 患者(中位年龄:52.5 岁,男性:51 [48.1%],初治患者:98 [92.5%])。主要终点是 12 周持续病毒学应答(SVR12)。次要终点是治疗期间发生的副作用。

结果

106 例 CHC GT2 患者中,103 例为 2a 基因型(97.2%),3 例为 2b 基因型(2.8%)。106 例患者中有 105 例(99.1%)确认 SVR12。1 例治疗失败的患者同时合并肝硬化和肝细胞癌。25 例患者除丙型肝炎病毒(HCV)外还合并肝硬化(Child-Turcotte-Pugh (CTP)-A,n=24;C,n=1),其中 24 例(96.0%)确认 SVR12。平均 HCV RNA 滴度为 2,629,159 IU/ml。23 例患者在治疗过程中出现血红蛋白水平下降(3.0mg/dL,平均),因此需要减少利巴韦林剂量(365.2mg,平均)。

结论

索非布韦联合利巴韦林治疗 CHC GT2 患者疗效显著,无严重的治疗相关不良反应。

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