首页> 外文期刊>Hepatology research: the official journal of the Japan Society of Hepatology >Real-world efficacy and safety of 12-week sofosbuvir/velpatasvir treatment for patients with decompensated liver cirrhosis caused by hepatitis C virus infection
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Real-world efficacy and safety of 12-week sofosbuvir/velpatasvir treatment for patients with decompensated liver cirrhosis caused by hepatitis C virus infection

机译:12周Sofosbuvir / Velpatasvir治疗的现实世界疗效和安全性对甲型肝炎病毒感染引起的失代偿肝硬化患者治疗

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摘要

Aim This study aimed to evaluate the real-world efficacy and safety of 12-week sofosbuvir/velpatasvir (SOF/VEL) treatment for patients with decompensated liver cirrhosis caused by hepatitis C virus (HCV) infection. Methods A total 72 of patients with Child-Pugh (CP) class B or C were enrolled. We evaluated the sustained virologic response at 12 weeks after the end of treatment (SVR12), adverse events (AEs), and changes in the liver function. Results All participants had genotype 1 or 2 HCV infection. At baseline, the numbers of patients with CP class B and C were 59 and 13, respectively. The overall SVR12 rate was 95.8% (69/72); 94.9% (56/59) in CP class B and 100% (13/13) in CP class C. The serum albumin level, prothrombin time and ascites were significantly improved (P = 6 mm) and hyperbilirubinemia (>= 2.0 mg/dL) were independent factors that interfered with the improvement in the CP score (P < 0.05). The most common AEs were encephalopathy (15.3%) and skin symptoms (7.9%). Two patients discontinued SOF/VEL due to AEs. Conclusions Treatment with SOF/VEL for 12 weeks was relatively safe and effective for patients with decompensated cirrhosis. An SVR provided an improvement of the liver function in the majority of patients. However, large portosystemic shunt and hyperbilirubinemia were independent factors that interfered with the improvement in the CP score.
机译:目的本研究旨在评估12周索非布韦/velpatasvir(SOF/VEL)治疗丙型肝炎病毒(HCV)感染所致失代偿期肝硬化患者的真实疗效和安全性。方法72例Child-Pugh(CP)B级或C级患者入选。我们评估了治疗结束后12周的持续病毒学应答(SVR12)、不良事件(AE)和肝功能变化。结果所有受试者均有1型或2型HCV感染。在基线检查时,CP B级和C级患者分别为59名和13名。总的SVR12发生率为95.8%(69/72);CP B组94.9%(56/59)和CP C组100%(13/13)。血清白蛋白水平、凝血酶原时间和腹水显著改善(P=6 mm),高胆红素血症(>=2.0 mg/dL)是影响CP评分改善的独立因素(P<0.05)。最常见的不良事件是脑病(15.3%)和皮肤症状(7.9%)。两名患者因不良事件停止使用SOF/VEL。结论SOF/VEL治疗失代偿期肝硬化12周相对安全有效。SVR改善了大多数患者的肝功能。然而,门体大分流和高胆红素血症是影响CP评分改善的独立因素。

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