Long Term Follow-up of Hepatitis C Cured Patients
Condition: Chronic Hepatitis C; Chronic Liver Disease; Cirrhosis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Liver Diseases
Study type: Observational

Summary: 
      Objectives:

      The general objective of the present project is to gain a better understanding of disease
      outcome in cACLD patients treated with the new oral DAA. In particular, the project will
      focus on:

      - To evaluate the long term prognosis of patients with compensated advanced chronic liver
      disease (cACLD) who achieve sustained virological response (SVR) after the new oral
      direct-acting antiviral agents (DAA), and determine clinical and elastographic basal and
      follow-up parameters to identify low and high risk groups of developing liver-related
      decompensation.

      Methods:

      Prospective cohort study in patients with cACLD in whom basal and annual clinical features
      and liver stiffness measurements (LSM) will be performed, and survival free of liver-related
      events will be analyzed.
    

Detailed description: 
      HYPOTHESIS:

      - The prognosis of cACLD patients who achieve SVR will improve during follow-up and this will
      be reflected in an improvement in liver and spleen stiffness and reduction of liver-related
      events. However, on an individual basis, because of many confounding factors, predictability
      is unknown.

      OBJECTIVES:

      The general objective of the present project is to gain a better understanding of disease
      outcome in cACLD patients treated with the new oral DAA. In particular, the project will
      focus on to determine simple clinical and elastographic basal and follow-up parameters to
      identify low and high risk groups for developing liver-related decompensation in cACLD
      patients who achieve SVR after DAA therapy. As a consequence of this, to provide guidance to
      clinicians to decide which cACLD patients should be indefinitely followed and which ones can
      be discharged from follow up, and also provide solid information to patients regarding the
      possible outcome of their cACLD after SVR.

        -  Study design: Prospective cohort study in an academic center to evaluate long term
           prognosis of patients with cACLD who achieve SVR after DAA therapy.

        -  Research subjects: All consecutive patients meeting inclusion criteria who have received
           DAA therapy from 1st January 2015 to 31st March 2016.

        -  Variables: Variables will be collected at baseline and annually for a period of 5 years.
           Basal data on genotype/subtype, interleukin 28B, viremia, type and duration of therapy.
           Data of liver function (INR, albumin, bilirubin), platelet count, aspartate
           aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP),
           gamma-glutamyltransferase (GGT), US findings (spleen size, collaterals), liver and
           spleen stiffness, body mass index (BMI), presence of metabolic syndrome factors
           (diabetes, dyslipemia, hypertension), alcohol and tabacco use, treatment with statins
           and development of liver-related events. The subgroup of patients with known esophageal
           varices prior to therapy will receive a second endoscopy 12-18 months after finishing
           therapy. Liver biopsies will be performed (after consent) at the end of follow-up (5
           years) in the group of patients who will be candidates for being discharged (LSM<10 kPa)
           to ensure cirrhosis regression and learn about the correlation between LSM and histology
           after SVR.

        -  Data collection methods and analysis: Patients will be monitored at the outpatient
           clinics every 6 months as per usual clinical practice. Every 6 months, clinical data,
           laboratory tests and abdominal US will be obtained. Liver and spleen stiffness
           (Fibroscan, Echosens) will be performed annually after finishing treatment by an
           experienced member (MP), using usual quality criteria. Spleen stiffness measurements
           will be performed under US spleen localization and with the same device and conditions
           than liver stiffness. All data will be registered in a database.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All consecutive patients meeting inclusion criteria who have received DAA therapy from 1st
        January 2015 to 31st March 2016.