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Protocol/Synopsis
of the multicentre, investigators initiated, retrospective, noninterventional study
Study tittle: Long term follow-up after Direct Acting Antivirals (DAA) based therapies in HCV
infected patients (CE-long)
Study supported: Central European Hepatological Collaboration (CEHC)
Designed: prof. dr hab. Robert Flisiak, Department of Infectious Diseases and Hepatology, Medical
University of Białystok, Poland, e-mail: [email protected], tel.: +48 605203525, fax: +48 85
7416921
Synopsis contributors (alphabetic order): Radan Bruha, Sylvia Drazilova, Robert Flisiak, Zsuzsanna
Gerlei, Gábor Horváth, Bela Hunyady, Peter Jarcuska, Jerzy Jaroszewicz, Pavol Kristian, Wojciech Lisik,
Michael Makara, Piotr Małkowski, Marian Oltman, Laszlo Rokusz, Krzysztof Simon, Lubomir Skladany,
Jan Sperl, Krzysztof Tomasiewicz, Pavel Trunecka, Petr Urbanek,
Location of centers: Czech Republic, Hungary, Poland, Slovakia; possible involvement other countries
from the central european region
National coordinators: Jan Sperl (Czech Rep.), Bela Hunyady (Hungary), Peter Jarcuska (Slovakia),
Robert Flisiak (Poland)
Design
The aim of the study is to analyse long-term efficacy of patients treated due to chronic HCV infection
with interferon-free regimens. Study include patients who achieved SVR or failed therapy. Due to
possible national differences and local preferences studies should be carried out initially on the
national level and then data will be combined. National databases should contain „core” information
which will be common for all countries, but additional data collection is possible on the site and
country level.
Study will be carried-out in two phases:
 1st phase should include patients treated with any interferon-free regimens containing DAA
who completed therapy between 1-02-2015 and 29-02-2016. Expected number of patients 400.
 2nd phase will be based on experience from the 1st phase and include patients treated with
any available IFN-free regimens containing DAA, who complete therapy between 29-02-2016
and 31-12-2017. Expected number of patients - 2000.
Each phase include two arms:
 Responders – who achieved SVR (undetectable HCV RNA 12 or 24 weeks after treatment).
End-points in this population will be:
 durability of SVR
 progression/regression of the liver disease
 risk of hepatocellular carcinoma (HCC)
 Non-responders – who failed IFN-free regimen. End-points in this population will be:
 analysis of further disease and treatment history
 Progression/regression of the liver disease
 risk of hepatocellular carcinoma (HCC)
Study visits
Study visists will be scheduled after 2 and 5 years (± 1 month) following end of treatment (EOT).
According to this protocol for the phase 1 (therapy completed between 1-02-2015 and 29-02-2016)
the 1st visit (2 years) should be scheduled between 1-01-2017 and 31-03-2018 and the 2nd visit (5
years) between 1-01-2020 and 31-03-2021. Respective dates for the phase 2 will be, visit 1st
between 1-02-2018 and 31-01-2020 and visit 2nd between 1-02-2021 and 31-01-2023.
Minimal (core) data to be collected:
 2/5 years history
 mortality liver and non-liver related,
 diseases/comorbidities,
 medication of comorbidities
 hospitalizations,
 OLTx,
 HCC,
 ascites,
 encephalopathy,
 esophageal, gastric or rectal varices bleeding,
 diuretics use (stable dosage or temporal use)
 renal insufficiency (including first of all hepato-renal syndrome)
 serious bacterial infections (including sepsis, bacterial peritonitis)
 Concentrations of bilirubin, albumin, INR, creatinin (for Child-Pugh and MELD calculation)
 Child-Pugh
 MELD
 Physical examination (current jaundice, ascites and encephalopathy, body weight, BMI)
 HCV RNA qualitative or quantitative
 USG
 Elastography
In addition to „core” data any other measures can be added on the centre or national level
Populations of special interest:
Because of potential value of analysis special attention should be paid to the following populations:
 HBV/HCV coinfected
 HIV/HCV coinfected
 chronic kidney diseases