Impact of Antiviral Therapy on Gastroesophageal Varices.
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|
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).
sustained virological response (SVR)
time frame: 12 weeks after treatment completion
Number of patients with gastroesophageal varices
time frame: gastroesophageal varices (GOV) before antiviral treatment and 12-24 weeks after treatment completion
Male or female participants at least 18 years old.
- 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
- Negative to provide signed informed consent.
- Negative to perform gastrointestinal endoscopy
|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.|
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