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

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.

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Key information

Conditions

Liver Transplantation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Virologic response at 12 weeks after completion of therapy

Time frame: 3 months

Assessment of virologic response after 3 months

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2017
First posted: Apr 28, 2017
Registry last updated: Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed