Hepacor study
Introduction
Recently, there has been significant progress made in the antiviral treatment of hepatitis C, with a success rate of almost 100%. Based on previous epidemiological surveys, we assume that despite the low incidence of hepatitis C in Slovakia, a significant proportion of infected patients remain undetected and therefore untreated. Higher incidence of infection can be expected especially in people with increased aminotransferase activity (so-called liver tests) or the presence of some of the risk factors for the transmission of infection.
„The aim of the study is to evaluate the correlation between the incidence of hepatitis C virus infection and at-risk populations. The results will be helpful in the targeted preparation of future hepatitis C screening strategies in order to make treatment accessible to all the infected individuals, including those who have yet been unware of their infection.“
Brief description of the study:
The Hepacor study is conducted to describe the relationship between risk groups and the incidence of hepatitis C virus (HCV) infection in the Slovak Republic
The study involves:
- MEDIREX GROUP ACADEMY n.o. as the “party implementing the research project “;
- 80 centers – health care providers in the field of general medicine and internal medicine in Slovakia as “investigators”;
- 1500 patients from the Košice and Bratislava self-governing regions who met the admission and exclusion criteria of the study were gradually included in the study.
- The enrolled patient provides his/her medical history data with a focus on risk factors for HCV infection, as well as blood samples are collected for the detection of antibodies to the hepatitis C virus (HCV).
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The determination of anti-HCV antibodies by chemiluminescent microparticle immunoassay (CMIA) is used in the project for the primary detection of hepatitis C virus carriers. Positive findings are subsequently confirmed by evidence using the HCV RNA by PCR (Polymerase chain reaction).
Anamnestic data, as well as test results, are recorded in the eCRF system and subsequently evaluated.
No drug is validated in the study. This study is for observational purposes only and the schedule of outpatient visits, and all treatment regimens are determined by the attending physician in accordance with standard clinical practice.
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Goals
The aim of the study is to evaluate the correlation between hepatitis C virus carriers and risk groups.
Activities
- Patient recruitment
Date: 1.5.2015 to 31.7.2016 - Completion of data collection
Date: 31.8.2016 - Statistical processing and evaluation of the collected data
Date: 9/1/2016 to 9/30/2016 - Publication of results
Date: 1.9.2016 – 31.12.2016