Overview

This trial is active, not recruiting.

Conditions chronic hepatitis c, cirrhosis
Treatments pegylated interferon alfa-2a + ribavirin, pegylated interferon alfa-2a + ribavirin + boceprevir, pegylated interferon alfa-2a + ribavirin +telaprevir, ledipasvir/sofosbuvir, ombitasvir/paritaprevir/ritonavir+dasabuvir, daclatasvir+sofosbuvir, simeprevir+sofosbuvir
Sponsor Parc de Salut Mar
Start date January 2010
End date June 2016
Trial size 374 participants
Trial identifier NCT02758509, PROGRESSIVE-C

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Pegylated interferon alfa-2a 180 microg/week plus ribavirin 800-1200 mg during 48 weeks according to routine practice and European Guidelines (EASL recommendations 2011)
pegylated interferon alfa-2a + ribavirin
Boceprevir 800 mg/8h or Telaprevir 750 mg/8h plus Pegylated interferon alfa-2a 180 microg/week plus ribavirin 800-1200 mg during 48 weeks according to routine practice and European Guidelines (EASL recommendations 2014)
pegylated interferon alfa-2a + ribavirin + boceprevir
pegylated interferon alfa-2a + ribavirin +telaprevir
Interferon-free direct-acting antiviral combinations according to routine practice and European Guidelines (EASL recommendations 2015) Fixed-dose combination of sofosbuvir (400 mg) and ledipasvir (90 mg) daily +/- ribavirin 12-24 weeks Fixed-dose combination of ombitasvir (75 mg), paritaprevir (12.5 mg) and ritonavir (50 mg) in one single tablet (two tablets once daily) and dasabuvir (250 mg) (one tablet twice daily) with ribavirin 800-1200 mg 12 weeks (Genotype 1b) or 24 weeks (genotype 1a) Daily sofosbuvir (400 mg) and daily simeprevir (150 mg) +/- ribavirin 12-24 weeks Daily sofosbuvir (400 mg) and daily daclatasvir (60 mg) +/- ribavirin 12-24 weeks
ledipasvir/sofosbuvir
ombitasvir/paritaprevir/ritonavir+dasabuvir
daclatasvir+sofosbuvir
simeprevir+sofosbuvir

Primary Outcomes

Measure
sustained virological response (SVR)
time frame: 12 weeks after treatment completion

Secondary Outcomes

Measure
Number of patients with gastroesophageal varices
time frame: gastroesophageal varices (GOV) before antiviral treatment and 12-24 weeks after treatment completion

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Parc de Salut Mar.