Hepatitis Elimination And Liver Care in South-East Austria (HEAL-S)
Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY
The HEAL-S study is a non-interventional study with retrospective data analysis. It consists of two parts. First a retrospective analysis based on nucleic acid testing (NAT) results will be performed. Two cohorts (HCV) and (HBV) will be established. Patients falling into one (or both) of the two cohorts will be invited to a prospective linkage-to-care study. In this part, patients are invited to the clinic, where the possibility of hepatitis treatment will be discussed.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• The target population for the HCV cohort consists of individuals with detectable plasma HCV RNA at the latest observation.
• The target population for the HBV cohort consists of individuals with detectable plasma HBV RNA at any time and no recorded HDV testing or a positive HDV serology.
Locations
Other Locations
Austria
Department of Internal Medicine, Division of Gastroenterology and Hepatology
RECRUITING
Graz
Contact Information
Primary
Vanessa Stadlbauer, Univ. Prof. Dr.
vanessa.stadlbauer@medunigraz.at
0043 316 385
Backup
Lavra Celcer, MPharm
gestudien@medunigraz.at
Time Frame
Start Date:2025-05-01
Estimated Completion Date:2026-10
Participants
Target number of participants:100
Treatments
HCV Cohort
Patients in the HCV cohort will be invited to laboratory evaluation. Patient visits correspond to routine and are not specific to the study - they include platelet count, liver biochemistry tests, virologic parameters (HCV, HIV, HBV), liver stiffness measurement using elastography (Fibroscan®, Echosens, France), counselling regarding HCV transmission and persons in whom plasma HCV RNA is detectable will be offered treatment with direct-acting antivirals (DAAs). The choice of DAA will be made according to individual comorbidities, comedications, previous HCV treatments, prescriber and personal preferences. Routine surveillance data under DAA treatment will be recorded. SVR is defined as HCV RNA not detectable after the end of DAA treatment. Furthermore, the suspected route of HCV transmission will be documented.
HBV Cohort
In the HBV cohort, patients with missing or positive but untreated HDV serology and with positive HBV viral load and negative HDV serology, but no evidence of linkage to care will be contacted via telephone or mail and invited for evaluation as described above and linked to care including treatment of HBV infection according to the applicable clinical practice guidelines as well as prescriber and personal preferences.~In case of positive HDV serology, HDV RNA testing will be performed and depending on the result, treatment of HBV/HDV coinfection will be initiated according to the applicable clinical practice guidelines as well as prescriber and personal preferences. Furthermore, the suspected route of HBV/HDV transmission will be assessed. Patient visit is part of routine treatment and done according to the respective treatment guidelines and the requirements of health insurance policy.