Early Treatment of Recurrent HCV- Infection Post Liver Transplantation in the Era of DAAs

Phase 4

Completed

• Conditions: Liver Transplantation
• Interventions: Drug: treatment of HCV with oral direct acting antiviral therapy

• Registration Number: NCT03133065
• Lead Sponsor: Ain Shams University

Brief Summary

The study aimed to present our experience in treating recurrent HCV genotype 4 infection post living donor liver transplantation (LDLT) since introduction of the second generation direct acting antiviral drugs (DAAs) in Egypt.

Detailed Description

This was a cohort study conducted in patients who had undergone LDLT for HCV related disease from 2014 to 2016 at in Ain Shams Center for Organ Transplantation (ASCOT) .The hypothesis early initiation of DAAs( after 12 weeks of the operation ) is effective and safe strategy in transplant recipients following LDLT. Patients who take the sofosbuvir and ribavirin after 6 months after transplantation were compared with those who take early treatment after 3 months of transplantation with sofosbuvir and daclatsvir+/- ribavirin..Patients were on regular follow up visits monthly to assess the clinical condition, any side effects, laboratory tests including complete blood picture, liver functions , renal functions and trough level of immunosuppressant drugs.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2016-12
• Status Verified: 2017-04
• Study Completion: 2017-04
• Study First Submitted: 2017-04-23
• Study First Submitted QC: 2017-04-25
• Last Update Submitted: 2017-04-25
• Study First Posted: 2017-04-28
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• All transplanted patients for HCV related disease in the period from 2014 to 2016

Exclusion Criteria

• Patients transplanted for other causes rather than HCv
• Patients with HBV and HCV co infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: treatment after 6 months post transplantation	treatment of HCV with oral direct acting antiviral therapy	53 patients received Sofosbuvir+ribavirin standard of care for treatment of HCV post liver transplantation for 6 months
Group 2: early treatment afer 3 months post transplantation	treatment of HCV with oral direct acting antiviral therapy	36 patients received other DAAs regiment for treatment of HCV post liver transplantation for 3- 6 months

Primary Outcome Measures

Name	Time	Method
Virologic response at 12 weeks after completion of therapy	3 months	Assessment of virologic response after 3 months