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.
Arab J Gastroenterol. 2021 Mar;22(1):23-27. doi: 10.1016/j.ajg.2020.09.001. Epub 2020 Nov 19.
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).
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.
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).
Sofosbuvir plus ribavirin was highly effective for the treatment of patients with CHC GT2 and had no serious, treatment-related adverse effects.
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。
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。
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)。
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。