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

NCT03133065 | Completed Phase 4 DMC

• 1 other identifier: HCV treatment
• Study Type: interventional
• Target: 89
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• Virologic response at 12 weeks after completion of therapy

  Assessment of virologic response after 3 months

  3 months

Study Arms (2)

Group 1: treatment after 6 months post transplantation

ACTIVE COMPARATOR

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

Drug: treatment of HCV with oral direct acting antiviral therapy

Group 2: early treatment afer 3 months post transplantation

ACTIVE COMPARATOR

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

Drug: treatment of HCV with oral direct acting antiviral therapy

Interventions

treatment of HCV with oral direct acting antiviral therapy DRUG

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.

Group 1: treatment after 6 months post transplantation; Group 2: early treatment afer 3 months post transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: April 23, 2017
• First Posted: April 28, 2017
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: April 28, 2017

Record last verified: 2017-04