GastrOesophageal Varices After Sustained Virological Response

Hepatitis C Clinical Trial

— GOVaSViR  

Official title:

Progression of Gastroesophageal Varices After Sustained Virological Response by Interferon-free Regimens in Patients With Advanced Fibrosis / Cirrhosis Due to Chronic Hepatitis C

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04191018
• Other study ID #: 10320319.6.0000.5262
• Status: Recruiting
• Start date: November 26, 2019
• Est. completion date: February 28, 2024

Study information

• Verified date: December 2019
• Source: Oswaldo Cruz Foundation
• Contact: Hugo Perazzo, PhD
• Phone: +5521 3865-9587
• Email: hugo.perazzo[@]ini.fiocruz.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chronic hepatitis C remains a public health issue because up to 70 million people are chronically infected by hepatitis C virus (HCV) worldwide. Presence of advanced fibrosis/cirrhosis might be associated with liver-related complications, such as hepatocellular carcinoma and oesophageal varices bleeding. Oesophageal varices (OV) might be present in up to 40% of patients with liver cirrhosis have and the mortality rates from bleeding might be up to 20% per episode. Early diagnosis of advanced fibrosis/cirrhosis associated with hepatitis C treatment are key features for preventive and therapeutic measures to reduce liver-related mortality in HCV-infected patients.

Liver elastography is a high accurate non-invasive test for diagnosis of advanced fibrosis/cirrhosis. Few different methods of liver elastography are currently available: transient elastography by Fibroscan and ultrasound elastography by point-shear wave (p-SWE) and 2D-shear wave (2D-SWE). Gastrointestinal endoscopy (GIE) has been considered the gold standard for screening or surveillance of esophageal varices. More recently, international guidelines have been recommending the use of non-invasive methods to indicate or avoid OV screening: Baveno VI guidelines proposed that compensated cirrhotic patients with a liver stiffness measurement (LSM) by transient elastography <20kPa and a platelet count >150,000/μL can avoid screening endoscopy. The use of direct-acting agents (DAAs) has revolutionized the treatment of chronic hepatitis C with high effectiveness shown using all-oral interferon-free regimens. HCV cure, sustained virological response (SVR), has been associated with lower rates of liver-related complications, increase in quality of life and decrease in waiting-list registrations for liver transplantation in patients with chronic hepatitis C. Preliminary studies have been reporting significant regression liver stiffness after SVR. However, it is unclear whether SVR might decrease portal hypertension leading to OV regression and a reduced risk of variceal bleeding. In addition, the use of non-invasive methods to avoid OV screening must be validated in HCV patients after SVR. The aims of this cross-sectional study with prospective inclusion of patients will be: (i) to evaluate the impact of SVR in portal hypertension in HCV patients with advanced fibrosis/liver cirrhosis treated by interferon-free regimens and (ii) to validate non-invasive methods to avoid OV screening by GIE

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 322
• Est. completion date: February 28, 2024
• Est. primary completion date: August 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Age = 18 years

• Presence of advanced fibrosis or cirrhosis (stage F=3 METAVIR) based on liver stiffness by transient elastography (= 9,5 kPa) or liver biopsy

• Gastrointestinal endoscopy at least 24 months before start of direct-acting agents for HCV treatment

• Liver stiffness measurement at least 18 months after SVR

Exclusion Criteria:

• Autoimmune hepatitis, hepatosplenic schistosomiasis or cholestasis diseases

• Liver transplantation

• Presence of high volume ascites or hepatocellular carcinoma

• Participation in programs of esophageal band ligation for eradication of esophageal varices

• Presence of signs of acute decompensated liver disease

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Liver Diseases

Intervention

Diagnostic Test:
• Liver elastography
Liver stiffness measurement
• Splenic elastography
Splenic stiffness measurement
• Gastrointestinal endoscopy
Gastrointestinal endoscopy

Locations

Country	Name	City	State
Brazil	Bonsucesso Federal Hospital	Rio De Janeiro
Brazil	Evandro Chagas National Institute of Infectious Diseases	Rio de Janeiro	Rio De Janeiro/RJ

Sponsors (1)

Lead Sponsor	Collaborator
Oswaldo Cruz Foundation

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of esophageal varices (portal hypertension) after SVR	Evaluation of presence/absence of esophageal varices after SVR in patients with advanced fibrosis or cirrhosis compared to before treatment	up to 48 months after SVR
Primary	Validation of the Baveno's criteria to avoid gastrointestinal endoscopy for screening of esophageal varices after SVR	Validation of the diagnostic performance of non-invasive tests (liver and splenic stiffness or biological markers) to screen esophageal varices in patients with advanced fibrosis/cirrhosis after SVR by DAA treatment for HCV	up to 48 months after SVR
Secondary	Incidence of regression of esophageal varices after SVR	Evaluation of absence of esophageal varices after SVR in patients with advanced fibrosis or cirrhosis and esophageal varices before treatment	up to 48 months after SVR