Impact of Antiviral Therapy on Gastroesophageal Varices.

May 18, 2018 updated by: José Antonio Carrion, Parc de Salut Mar

Efficacy and Safety of Interferon Based Therapy and Interferon-free Direct-acting Antivirals in Cirrhotic Patients With Hepatitis C. Impact of Antiviral Therapy on Gastroesophageal Varices.

Hepatitis C virus (HCV) chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The use of pegylated interferon (PEG-INF) with ribavirin (RBV) has supposed high serious adverse events (SAEs) and low efficacy, especially in patients with cirrhosis. The introduction of 1st generation protease inhibitors (PIs) in genotype-1 (GT1) HCV, such as boceprevir (BOC) and telaprevir (TVR), improved the efficacy but increased the SAEs. Currently, interferon-free direct-acting antivirals (IF-DAAs) achieve great effectiveness with minimum SAEs. However, studies evaluating efficacy and safety of DAAs in cirrhotic patients are limited in real clinical practice. The aim of our study is to evaluate in HCV-cirrhotic patients the efficacy and safety of 3 treatment strategies (PEG-IFN/RBV, PEG-IFN/RBV/PIs, and IF-DAAs) in routine practice according to European guidelines from 2010 to 2015. The secondary aim is to evaluate the impact of sustained virological response on gastroesophageal varices (GOV).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

237

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic hepatitis C by genotype 1 and liver cirrhosis

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • Signed informed consent.
  • Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
  • Liver cirrhosis (transient elastography ≥ 14 kPa).
  • Baseline upper gastrointestinal endoscopy to assess gastroesophageal varices

Exclusion Criteria:

  • Negative to provide signed informed consent.
  • Negative to perform gastrointestinal endoscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PEG/RBV
Pegylated interferon alfa-2a 180 microg/week plus ribavirin 800-1200 mg during 48 weeks according to routine practice and European Guidelines (EASL recommendations 2011)
Drug: Pegylated interferon alfa-2a + Ribavirin
PEG/RBV+BOC or TVR
Boceprevir 800 mg/8h or Telaprevir 750 mg/8h plus Pegylated interferon alfa-2a 180 microg/week plus ribavirin 800-1200 mg during 48 weeks according to routine practice and European Guidelines (EASL recommendations 2014)
Drug: Pegylated interferon alfa-2a + Ribavirin + Boceprevir
Drug: Pegylated interferon alfa-2a + Ribavirin +Telaprevir
IF-DAAs

Interferon-free direct-acting antiviral combinations according to routine practice and European Guidelines (EASL recommendations 2015)

  • Fixed-dose combination of sofosbuvir (400 mg) and ledipasvir (90 mg) daily +/- ribavirin 12-24 weeks
  • Fixed-dose combination of ombitasvir (75 mg), paritaprevir (12.5 mg) and ritonavir (50 mg) in one single tablet (two tablets once daily) and dasabuvir (250 mg) (one tablet twice daily) with ribavirin 800-1200 mg 12 weeks (Genotype 1b) or 24 weeks (genotype 1a)
  • Daily sofosbuvir (400 mg) and daily simeprevir (150 mg) +/- ribavirin 12-24 weeks
  • Daily sofosbuvir (400 mg) and daily daclatasvir (60 mg) +/- ribavirin 12-24 weeks
Drug: Ledipasvir/Sofosbuvir
Drug: Ombitasvir/paritaprevir/ritonavir+Dasabuvir
Drug: Daclatasvir+Sofosbuvir
Drug: Simeprevir+Sofosbuvir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sustained virological response (SVR)
Time Frame: 12 weeks after treatment completion
undetectable HCV viral load 12 weeks after the end of antiviral treatment in each cohort of antiviral treatment
12 weeks after treatment completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with gastroesophageal varices
Time Frame: gastroesophageal varices (GOV) before antiviral treatment and 12-24 weeks after treatment completion
Number of patients with GOV before and 12-24 weeks after treatment completion in patients with or without SVR
gastroesophageal varices (GOV) before antiviral treatment and 12-24 weeks after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 15, 2017

Study Completion (Actual)

October 15, 2017

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimate)

May 2, 2016

Study Record Updates

Last Update Posted (Actual)

May 21, 2018

Last Update Submitted That Met QC Criteria

May 18, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROGRESSIVE-C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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