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Impact of Antiviral Therapy on Gastroesophageal Varices.

NCT02758509 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 237

Last updated 2018-05-21

No results posted yet for this study

Summary

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).

Conditions

  • Chronic Hepatitis C
  • Cirrhosis

Interventions

DRUG

Pegylated interferon alfa-2a + Ribavirin

DRUG

Pegylated interferon alfa-2a + Ribavirin + Boceprevir

DRUG

Pegylated interferon alfa-2a + Ribavirin +Telaprevir

DRUG

Ledipasvir/Sofosbuvir

DRUG

Ombitasvir/paritaprevir/ritonavir+Dasabuvir

DRUG

Daclatasvir+Sofosbuvir

DRUG

Simeprevir+Sofosbuvir

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-01
Primary Completion
2017-06-15
Completion
2017-10-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02758509 on ClinicalTrials.gov