The Effect of Cyclosporine A Versus Tacrolimus on the Response to Antiviral Treatment After HCV Genotype -4 Recurrence in Recipients of Living Donor Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 主要终点
- sustained virological response
研究概览
简要总结
Background and Aim: The immunosuppression influence on the response to antiviral therapy (AVT) for recurrent hepatitis C virus (HCV) infection in liver transplant (LT) recipients remains controversial, especially for the rarely investigated genotype 4.This study aims to compare the effects of the two widely used calcineurin inhibitors(CNIs)(Cyclosporine A (CsA) and tacrolimus (Tac)) on the therapeutic response to different AVT regimens. Method: In126 living donor liver transplant (LDLT) recipients with recurrent HCV infection, participants were categorized to three groups according to AVT. Group one received pegylated interferon (Peg IFN-α 2a) and ribavirin (RBV) (n= 44), group two received the direct antiviral agent (DAA) sofosbuvir plus RBV (n=52) and group three received daclatasvir, sofosbuvir (other DAAs) plus RBV(n=30) each group was further subdivided according to primary immunosuppression (CsA or Tac). The sustained virological response (SVR) and relapse rates were considered the primary therapeutic outcomes of AVT. The virological response guided therapy end points for AVT were considered the secondary outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •group(I):participants received Peg IFN-α 2a and RBV therapy who fulfilled the following inclusion criteria:
- •Age between 18 and 65 years ;
- •elevated aminotransferase levels (ALT and AST)
- •detectable HCV RNA by polymerase chain reaction (PCR)
- •liver biopsy results consistent with HCV recurrence using the Metavir scoring system (Metavir ≥A1F1)
- •For group II and III:
- •age between 18 and 75 years
- •detectable HCV RNA by PCR
排除标准
- •if they were younger than 18 years or older than 65 years or had one of the following criteria
- •alcoholic
- •poorly controlled autoimmune disease
- •significant cardiac disease
- •suicidal ideation
- •a history of suicide attempt
- •major psychosis
- •serum creatinine ˃3 mg/dl
- •thyroid dysfunction
- •combined kidney-liver transplantation
- •were currently pregnant or planning pregnancy.
- •Group II and III:
- •younger than 18 years or older than 75 years
- •total bilirubin (T.Bil) >3 mg/dl
- •serum albumin< 2.8 mg/dl
- •international normalized ratio ≥1.7
- •Platelet count < 5000/mm3
- •HCC, except 4 weeks after intervention with no evidence of activity using computed tomography or magnetic resonance imaging
- •extra hepatic malignancy except after two years of disease free-interval
- •uncontrolled diabetes evidenced by glycated haemoglobin >9%
- •were pregnant .
研究组 & 干预措施
IFN group received Cyclosporine
Living donor liver transplantation recipients with recurrent HCV received Peg IFN-α 2a and RBV as antiviral therapy and Cyclosporine A as primary immunosuppression ,this was routinely taken not as intervention according to local practice
干预措施: Cycloserine,Tacrolimus (Drug)
IFN group received tacrolimus
Living donor liver transplantation recipients with recurrent HCV received Peg IFN-α 2a and RBV as antiviral therapy and Tacrolimus as primary immunosuppression ,this was routinely taken not as interventing according to local practice
干预措施: Cycloserine,Tacrolimus (Drug)
Sof plus Rbv group received Cyclosporine
Living donor liver transplantation recipients with recurrent HCV received sofosbuvir and RBV as antiviral therapy and Cyclosporine as primary immunosuppression,this was routinely taken not as intervention according to local practice
干预措施: Cycloserine,Tacrolimus (Drug)
Sof plus Rbv received tacrolimus
Living donor liver transplantation recipients with recurrent HCV received sofosbuvir and RBV as antiviral therapy and Tacrolimus as primary immunosuppression,this was routinely taken not as intervention according to local practice
干预措施: Cycloserine,Tacrolimus (Drug)
Sof,dac pus ribavirin received cyclosporine
Living donor liver transplantation recipients with recurrent HCV received daclatasvir, sofosbuvir and RBV as antiviral therapy and Cyclosporine as primary immunosuppression,this was routinely taken not as intervention according to local practice
干预措施: Cycloserine,Tacrolimus (Drug)
sof,dac plus rbv received tacrolimus
Living donor liver transplantation recipients with recurrent HCV received daclatasvir, sofosbuvir and RBV as antiviral therapy and Tacrolimus as primary immunosuppression,this was routinely taken not as intervention according to local practice
干预措施: Cycloserine,Tacrolimus (Drug)
结局指标
主要结局
sustained virological response
时间窗: 24 weeks for group I and 12 weeks for group II and III
a negative serum HCV RNA
次要结局
未报告次要终点
研究者
Iman Fawzy Montasser
Associate professor -Tropical medicine-faculty of medicine-Ain Shams University
Ain Shams University