Impact of Antiviral Therapy on Gastroesophageal Varices.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

237 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2017-10-15

Brief Summary

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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).

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Detailed Description

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Conditions

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Chronic Hepatitis C Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Pegylated interferon alfa-2a + Ribavirin

Intervention Type DRUG

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)

Pegylated interferon alfa-2a + Ribavirin + Boceprevir

Intervention Type DRUG

Pegylated interferon alfa-2a + Ribavirin +Telaprevir

Intervention Type DRUG

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

Ledipasvir/Sofosbuvir

Intervention Type DRUG

Ombitasvir/paritaprevir/ritonavir+Dasabuvir

Intervention Type DRUG

Daclatasvir+Sofosbuvir

Intervention Type DRUG

Simeprevir+Sofosbuvir

Intervention Type DRUG

Interventions

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Pegylated interferon alfa-2a + Ribavirin

Intervention Type DRUG

Pegylated interferon alfa-2a + Ribavirin + Boceprevir

Intervention Type DRUG

Pegylated interferon alfa-2a + Ribavirin +Telaprevir

Intervention Type DRUG

Ledipasvir/Sofosbuvir

Intervention Type DRUG

Ombitasvir/paritaprevir/ritonavir+Dasabuvir

Intervention Type DRUG

Daclatasvir+Sofosbuvir

Intervention Type DRUG

Simeprevir+Sofosbuvir

Intervention Type DRUG

Eligibility Criteria

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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