Effect of Cyclosporine A Versus Tacrolimus on Response to Antiviral Therapy After Hepatitis C Genotype -4 Recurrence Post Liver Transplantation

NCT ID: NCT03665766

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 126 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-15
• Study Completion Date: 2018-04-02

Brief Summary

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.

Conditions

Liver Transplantation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Cycloserine,Tacrolimus

Intervention Type: 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

Cycloserine,Tacrolimus

Intervention Type: 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

Cycloserine,Tacrolimus

Intervention Type: 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

Cycloserine,Tacrolimus

Intervention Type: 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

Cycloserine,Tacrolimus

Intervention Type: 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

Cycloserine,Tacrolimus

Intervention Type: DRUG

Interventions

Cycloserine,Tacrolimus

Intervention Type: DRUG

Eligibility Criteria

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

Exclusion Criteria

• 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 .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Iman Fawzy Montasser

Associate professor -Tropical medicine-faculty of medicine-Ain Shams University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ASU-1124568

Identifier Type: -

Identifier Source: org_study_id