GastrOesophageal Varices After Sustained Virological Response (GOVaSViR)

O

Oswaldo Cruz Foundation

Status

Enrolling

Conditions

Hepatitis C
Liver Diseases

Treatments

Diagnostic Test: Splenic elastography
Diagnostic Test: Gastrointestinal endoscopy
Diagnostic Test: Liver elastography

Study type

Observational

Funder types

Other

Identifiers

NCT04191018
10320319.6.0000.5262

Details and patient eligibility

About

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

Enrollment

322 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

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Central trial contact

Hugo Perazzo, PhD

Data sourced from clinicaltrials.gov

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