Hepatitis C Clinical Trial
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
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
n/a
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