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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Liver Transplantation

Treatments: Drug: treatment of HCV with oral direct acting antiviral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03133065

HCV treatment

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

Group 1: treatment after 6 months post transplantation

Active Comparator group

Description:

53 patients received Sofosbuvir+ribavirin standard of care for treatment of HCV post liver transplantation for 6 months

Treatment:

Drug: treatment of HCV with oral direct acting antiviral therapy

Group 2: early treatment afer 3 months post transplantation

Active Comparator group

Description:

36 patients received other DAAs regiment for treatment of HCV post liver transplantation for 3- 6 months

Treatment:

Drug: treatment of HCV with oral direct acting antiviral therapy