Impact of Antiviral Therapy on Gastroesophageal Varices.

NCT02758509 | Completed

• 1 other identifier: PROGRESSIVE-C
• Study Type: observational
• Target: 237
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Chronic Hepatitis C; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• sustained virological response (SVR)

  undetectable HCV viral load 12 weeks after the end of antiviral treatment in each cohort of antiviral treatment

  12 weeks after treatment completion

Secondary Outcomes (1)

• Number of patients with gastroesophageal varices

  gastroesophageal varices (GOV) before antiviral treatment and 12-24 weeks after treatment completion

Study Arms (3)

PEG/RBV

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)

Drug: Pegylated interferon alfa-2a + Ribavirin

PEG/RBV+BOC or TVR

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)

Drug: Pegylated interferon alfa-2a + Ribavirin + Boceprevir; Drug: Pegylated interferon alfa-2a + Ribavirin +Telaprevir

IF-DAAs

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

Drug: Ledipasvir/Sofosbuvir; Drug: Ombitasvir/paritaprevir/ritonavir+Dasabuvir; Drug: Daclatasvir+Sofosbuvir; Drug: Simeprevir+Sofosbuvir

Interventions

Pegylated interferon alfa-2a + Ribavirin DRUG

PEG/RBV

Pegylated interferon alfa-2a + Ribavirin + Boceprevir DRUG

PEG/RBV+BOC or TVR

Pegylated interferon alfa-2a + Ribavirin +Telaprevir DRUG

PEG/RBV+BOC or TVR

Ledipasvir/Sofosbuvir DRUG

IF-DAAs

Ombitasvir/paritaprevir/ritonavir+Dasabuvir DRUG

IF-DAAs

Daclatasvir+Sofosbuvir DRUG

IF-DAAs

Simeprevir+Sofosbuvir DRUG

IF-DAAs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic hepatitis C by genotype 1 and liver cirrhosis

You may qualify if:

• 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

You may not qualify if:

• Negative to provide signed informed consent.
• Negative to perform gastrointestinal endoscopy

Sponsors & Collaborators

• Parc de Salut Mar: lead

Related Publications (1)

• Puigvehi M, Londono MC, Torras X, Lorente S, Vergara M, Morillas RM, Masnou H, Serrano T, Miquel M, Gallego A, Lens S, Carrion JA. Impact of sustained virological response with DAAs on gastroesophageal varices and Baveno criteria in HCV-cirrhotic patients. J Gastroenterol. 2020 Feb;55(2):205-216. doi: 10.1007/s00535-019-01619-0. Epub 2019 Sep 6.

  PMID: 31493238 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Fibrosis

Interventions

peginterferon alfa-2a; Ribavirin; N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; ledipasvir, sofosbuvir drug combination; Viekira Pak

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: May 2, 2016
• Study Start: January 1, 2010
• Primary Completion: June 15, 2017
• Study Completion: October 15, 2017
• Last Updated: May 21, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share