Impact of Antiviral Therapy on Gastroesophageal Varices.

Parc de Salut Mar

Status: Completed

Conditions: Cirrhosis; Chronic Hepatitis C

Treatments: Drug: Daclatasvir+Sofosbuvir; Drug: Pegylated interferon alfa-2a + Ribavirin +Telaprevir; Drug: Ledipasvir/Sofosbuvir; Drug: Simeprevir+Sofosbuvir; Drug: Pegylated interferon alfa-2a + Ribavirin; Drug: Pegylated interferon alfa-2a + Ribavirin + Boceprevir; Drug: Ombitasvir/paritaprevir/ritonavir+Dasabuvir

Study type: Observational

Funder types: Other

Identifiers

NCT02758509

PROGRESSIVE-C

Details and patient eligibility

About

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).

Enrollment: 237 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

237 participants in 3 patient groups

PEG/RBV

Description:

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)

Treatment:

Drug: Pegylated interferon alfa-2a + Ribavirin

PEG/RBV+BOC or TVR

Description:

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)

Treatment:

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

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

IF-DAAs

Description:

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

Treatment:

Drug: Daclatasvir+Sofosbuvir

Drug: Simeprevir+Sofosbuvir

Drug: Ledipasvir/Sofosbuvir

Drug: Ombitasvir/paritaprevir/ritonavir+Dasabuvir