Impact of Antiviral Therapy on Gastroesophageal Varices.

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02758509

Enrollment

237

Registered

2016-05-02

Start date

2010-01-01

Completion date

2017-10-15

Last updated

2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C, Cirrhosis

Brief 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).

Interventions

DRUGPegylated interferon alfa-2a + Ribavirin

DRUGPegylated interferon alfa-2a + Ribavirin + Boceprevir

DRUGPegylated interferon alfa-2a + Ribavirin +Telaprevir

DRUGLedipasvir/Sofosbuvir

DRUGOmbitasvir/paritaprevir/ritonavir+Dasabuvir

DRUGDaclatasvir+Sofosbuvir

DRUGSimeprevir+Sofosbuvir

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Number of patients with gastroesophageal varices	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026