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

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03133065
• Other study ID #: HCV treatment
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2017
• Last updated: April 25, 2017
• Start date: September 2014
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• treatment of HCV with oral direct acting antiviral therapy
A total number of 89 patients transplanted for HCV genotype 4 related end stage liver disease Were included in this study 53 PATIENTS were treated after 6 months of transplantation with sofosbuvir 400mg and weight based ribavirin for 24 weeks. 7 patients were treated with sofosbuvir 400mg + simeprevir 150 mg + weight based ribavirin for 12 weeks after 6 months post transplant. In September 2015, we started to adopt early treatment strategy for all recipients after the first 3months post- transplant. 26 recipients were treated with sofosbuvir 400mg+Daclatasvir 60mg ± weight based ribavirin for 12 weeks or 24 weeks. 2 recipient are treated with sofosbuvir 400mg + ledipasvir 90mg for 24 weeks and one recipient is treated with fixed-dose combination of ombitasvir (12.5 mg), paritaprevir (75 mg) and ritonavir (50 mg) + weight based ribavirin due to having persistent renal impairment post transplantation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic response at 12 weeks after completion of therapy	Assessment of virologic response after 3 months	3 months