Clinical trial NCT06834178: Non-interventional Study to Assess the Number of People With Untreated/Unknown HBV + HDV and HCV in South-East Austria
Official title: Hepatitis Elimination And Liver Care in South-East Austria (HEAL-S)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HBV
HCV
HDV
Coinfection
Hepatitis B Coinfection
Hepatitis B
Keywords: HBV
HCV
HDV
Hepatitis B and D coinfection
untreated hepatitis
Hepatitis B
Hepatitis C
Hepatitis treatment
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Medical University of Graz
First posted: 2025-02-19
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients in South-East Austria with undiagnosed HCV infection or with unknown HDV status in case of HBV infection.

Brief 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.

Detailed description: We hypothesize that in South-East Austria, a relevant number of persons are unaware of their HCV infection or their HDV status in case of HBV coinfection and therefore not yet sufficiently linked to care.

The study consists of two parts:

1. First a retrospective analysis based on nucleic acid testing (NAT) results will be performed: all results for HCV-RNA and HBV-DNA + HDV serology results obtained from the specific laboratories of the Diagnostic and Research Institute of Hygiene, Microbiology and Environmental Medicine between January 01, 2014 to December 31, 2023 will be retrieved through the laboratory information system. In the extracted dataset we will first verify that patients are alive and have a valid SVNR in Austria. Eligible patients (estimated 800) will be manually checked in our electronic patient record system (openMEDOCS) to verify that the patients had not been treated for HCV infection any time or lack HDV testing in case of HBV coinfection. The remaining patients comprise the target population.
2. 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. The patients from the target population will be contacted via telephone or mail and invited for assessment at Medical University of Graz. Numbers and percentages of persons called, reached, clinically assessed, treated, and cured (sustained virological response, SVR) will be evaluated.

2.1. 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.

2.2. 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.

The active study participation ends with the linkage-to-care. The treatment of the viral hepatitis infection is not part of the study any more. The outcome of therapy will be assessed via chart review in retrospect.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* No valid SVRN (german: Sozialversicherungsnummer, english: Social insurance number)
* No contact details available
* Documented Sustained Virological Response (HCV cohort)
* Documented assessment of HDV status (HBV cohort)

Primary outcomes:
measure: Number of HCV patients that can be linked to care
timeFrame: 10/2024 - 10/2026
measure: Number of HDV patients that can be linked to care
timeFrame: 10/2024 - 10/2026
Secondary outcomes:
measure: Virological response (SVR) rate
timeFrame: 10/2024 - 10/2026
measure: Prevalence of HCV, HBV and HDV infection in South-East Austria
timeFrame: 10/2024 - 10/2026
measure: Number of South-East Austria HCV patients treated since DAA treatment has been available
timeFrame: 10/2024 - 10/2026
measure: Number of HCV re-infections
timeFrame: 10/2024 - 10/2026
measure: Number of patients with HBV infection who were not tested for HDV infection
timeFrame: 10/2024 - 10/2026
measure: Number of patients with HBV infection who were not tested for HDV infection
timeFrame: 10/2024 - 10/2026
measure: Number of HBV patients with HDV infection
timeFrame: 10/2024 - 10/2026
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Internal Medicine, Division of Gastroenterology and Hepatology
state: Styra
Study officials:
affiliation: Medical University of Graz, Department of Gastroenterology and Hepatology, Medical University of Graz
name: Vanessa Stadlbauer-Köllner, Univ. Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Diagnostic and Research Institute of Hygiene, Microbiology and Environmental Medicine, Medical University of Graz
name: Harald H. Kessler, Univ. Prof. Dr.
role: STUDY_DIRECTOR
References: