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索磷布韦联合达拉他韦治疗肾移植合并丙肝的疗效与安全性

Efficacy and safety of sofosbuvir and daclatasvir for kidney transplantation patients with hepatitis C virus infection

摘要:

目的 研究索磷布韦联合达拉他韦治疗肾移植合并丙型肝炎的疗效和安全性.方法 连续入组自2016年3月至2018年1月山东大学第二医院肝病科收治的肾移植合并丙型肝炎患者.人组患者给予索磷布韦联合达拉他韦及利巴韦林治疗,疗程12周或24周,收集患者基线、治疗2周、4周、8周、治疗结束、停药12周、24周的系列血清,检测肝肾功能指标、血红蛋白、HCV RNA、抗排异药物浓度;观察治疗过程中的不良反应及抗排异药物调整情况.结果 共纳入13例患者,均为初治,年龄46.84±7.79岁,男10例,女3例,非肝硬化10例,肝硬化3例(1例为失代偿期);基因1b型者6例,6a型者3例,3a型者2例,2a型者2例.12例基线肾小球滤过率的估计值(eGFR)> 30 ml/min·1.73 m2,1例基线eGFR<30 ml/min·1.73 m2,疗程12周者9例,24周者4例.治疗后第4周HCVRNA转阴率为92.3%(12/13),治疗结束时HCV RNA均未检测到.停药12周的持续病毒学应答率为100%(13/13).治疗期间患者的肾功能基本保持稳定,未发现严重不良事件,无因药物不良反应而停用抗病毒药物.结论 索磷布韦联合达拉他韦方案治疗13例肾移植合并丙型肝炎的疗效及安全性良好.

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Objective To study the efficacy and safety of sofosbuvir and daclatasvir regimens for patients who received kidney transplantation (KT) with hepatitis C virus (HCV) infection.Methods This study enrolled a prospective cohort of consecutive KT patients with HCV infection from March 2016 to January 2018 in the hepatology Department of the Second Hospital of Shandong University.They were given sofosbuvir combined with daclatasvir,with or without ribavirin.The course of treatment was 12 weeks or 24 weeks.Clinical assessment,conventional liver and kidney biochemical parameters,hemoglobin,serum HCV RNA,as well as the types of immunosuppressive drugs and their doses were assessed routinely as follows:at the beginning of treatment;2,4,and 8 wk post treatment;at the end of treatment (EOT);and at 12,24 wk after the therapy was completed.Adverse events and adjustment of anti-rejection drugs were surveilled during the treatment period.Results A total of 13 patients were enrolled.All patients were naive to treatment.Their mean age was 46.84±7.79 years.There were 10 males and 3 females,3 patients had cirrhosis (1 cases had decompensated cirrhosis),10 patients had no cirrhosis.They were infected with HCV genotype 1 (6/13 GT1b),genotype 3 (2/13 GT3a) and genotype 6 (3/13 GT6a),and genotype 2 (2/13 GT2a).Twelve patients' estimated glomerular filtration rate (eGFR) was > 30 ml/min per 1.73 m2 at the beginning of treatment,1 patient's eGFR was <30 ml/min · 1.73 m2;9 patients received 12 wk therapy,4 patients received 24 wk therapy.Twelve patients had undetectable viral load by week 4 of treatment.All patients had undetectable HCV viral load at the end of treatment.Sustained virological response (SVR) 12 rate was achieved in 100% (13/13) of the recipients.The basic renal function remained stable during the course of treatment. No serious adverse events were observed during the treatment.Antiviral therapy was not discontinued due to side effects in any patient.Conclusions Sofosbuvir and daclatasvir for treatment of KT patients with HCV infection are highly effective and safe.

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