Impact of Antiviral Therapy on Gastroesophageal Varices.

• Status: Completed
• Trial end date: 2017-10-15
• Target enrollment: 0
• Participant gender: All

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).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Parc de Salut Mar
• Treatments: Antiviral Agents; Interferon alpha-2; Interferon-alpha; Interferons; Ledipasvir; Ledipasvir, sofosbuvir drug combination; Peginterferon alfa-2a; Ribavirin; Ritonavir; Simeprevir; Sofosbuvir

Criteria

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