NCT02758509

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
• Phase: —
• Study type: Observational
• Enrollment: 237 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2010-01-01
• Primary completion: 2017-06-15
• Completion: 2017-10-15
• First posted: 2016-05-02
• Last updated: 2018-05-21