Impact of Antiviral Therapy on Gastroesophageal Varices.
Status:
Completed
Trial end date:
2017-10-15
Target enrollment:
Participant gender:
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).