Clinical trial NCT06248580: Find HDV and Determine Its Status in Turkey
Official title: Find HDV and Determine Its Status in Turkey "SITU(HD)VATION"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Hepatitis D Infection
Fibrosis, Liver
Hepatocellular Carcinoma
Cirrhosis, Liver
Transmission Vertical
Keywords: Chronic hepatitis D
Hepatocellular Carcinoma
Liver Cirrhosis
Lead sponsor: Guven Health Group
Sponsor class: OTHER
Collaborators: name: SOUTHEAST NEUROLOGY AND INFECTIOUS DISEASES SOCIETY
name: Gilead Sciences
First posted: 2024-02-08
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: To ensure that 20,000 patients with HBsAg positivity in Diyarbakir, Mardin, Batman and Sanliurfa are evaluated for HDV infection. To investigate HDV positive patients for liver fibrosis using the fibroscan method.

Brief summary: The aim of these study to determine the prevalence of hepatitis Delta virus (HDV) infections and the prognosis of HDV patients in Turkey's southeast. The investigators intend to arrange training sessions for 250 family physicians in Diyarbakir, Batman, Mardin, and Sanliurfa in order to determine those goals. The investigators will talk about diagnosing hepatitis B virus (HBV), HDV, hepatitis C virus (HCV), and Human Immunodeficiency virus (HIV) infections during these events. To ensure that patients with simultaneous HDV infection are evaluated for HIV/HCV and to detect liver fibrosis with a non-invasive method.

Detailed description: Study Objectives:

The aim of these study to determine the prevalence of HDV infections and the prognosis of HDV patients in Turkey's southeast. The investigators intend to arrange training sessions for 250 family physicians in Diyarbakir, Batman, Mardin, and Sanliurfa in order to determine those goals. The investigators will talk about diagnosing HBV, HDV, HCV, and HIV infections during these events. To ensure that patients with simultaneous HDV infection are evaluated for HIV/HCV and to detect liver fibrosis with a non-invasive method.

Primary Objectives:

To reveal the status of HDV infection in Turkey within the framework of the national hepatitis elimination program by providing training to family physicians.

Second Objectives:

* To determine the frequency and type of HDV in HBV patients (HDV/HCV co-infection).
* Providing HBV, HCV, HDV and HIV awareness training to family physicians.
* To determine the virological and liver fibrosis of patients with anti-Delta positivity.
* To determine the status of patients with HBV infection who are followed by family physicians.
* To ensure that patients with HDV infection are evaluated for liver cirrhosis and liver cancer.
* To determine the HDV/HIV co-infection rate.
* To determine the HDV/HCV co-infection rate.
* Determining the vertical transmission rate in viral hepatitis and contributing to elimination by emphasizing the importance of this rate.

Study Population:

To ensure that 20,000 patients with HBsAg positivity in Diyarbakir, Mardin, Batman and Sanliurfa are evaluated for HDV infection. To investigate HDV positive patients for liver fibrosis using the fibroscan method.

Number of Volunteers to Participate in the Study:

It is planned to include a total of 20,000 patients with HBsAg positivity from four provinces in this study.

Study Design:

Hepatitis Delta Virus infection poses a greater risk of developing both cirrhosis and liver cancer than other viral hepatitis agents. The Southeastern Anatolia region where HDV infection is most common in Turkey. It is planned to include four provinces (Diyarbakir, Batman, Mardin and Sanliurfa) in this study. In this study, family physicians will be reached through the Health Directorate of each province.

All Family Physicians will be educated about the prognosis and complications of HBV and especially HDV infection. The training will be carried out by the Infectious Diseases or Gastroenterology specialists of that province. Anti-Delta will be tested in all patients applying to health institutions. At the same time, all HBsAg positive patients followed by each family physician will be evaluated for the presence of HDV infection. All patients with anti-Delta positivity will be tested for HIV and HCV to determine their HDV/HIV co-infection and HDV/HCV co-infection status. Simultaneously, the liver fibrosis of patients with Anti-Delta positivity will be evaluated by the fibroscan method. Fibrosis-4 (FIB-4) and Child Pugh scoring will be performed on all patients simultaneously.

After receiving ethics committee approval for this study, the data collection process for family physicians' training and follow-up patients will be completed between April and July 2024. In total, it is anticipated to reach 250 Family Physicians in the entire region. In addition, demographic characteristics of HDV patients will be determined by reaching the Infectious Diseases and Gastroenterology Centers in four provinces. A five-question survey would be organized for all family physicians before and after the training in order to measure their knowledge level and evaluate the contribution of the training. This survey will be applied and analyzed via Slido.

After determining the biochemical and virological status of all HDV infections detected in four provinces, fibrosis of the liver will be measured with Fibroscan and FIB-4, which are non-invasive methods. As a result of the study, it is aimed to diagnose an estimated 1000 HDV-infected patients and score their liver fibrosis. It is aimed to complete the biochemical, virological, demographic and liver fibrosis status and statistical analyzes of all HDV-infected patients by 31.12.2024. The status of all patients in need of treatment or transplantation will be determined and their follow-up and treatment will be carried out in line with the recommendations of international and national treatment guidelines. The writing phase of all analyzed data will be completed and finalized by 31.01.2025.

One of the important reasons why both hepatitis B infection (HBV) and HDV infections are common is related to the fact that until recently vertical transmission was an important risk factor.

Both the diagnostic approach and follow-up and effective treatment options for HDV infections are still limited. It is also clearly known that HDV infection carries a higher risk of hepatocellular carcinoma (HCC) and cirrhosis than HBV infection. It is known that 90% of patients with viral hepatitis origin who are transplant candidates in our country have HDV infection.

Eligibility criteria: Inclusion Criteria:

* Adults (Age≥18)
* Being HBsAg positive for at least six months
* Being a citizen of the Republic of Türkiye

Exclusion Criteria:

* There are no exclusion criteria in this study.

Primary outcomes:
measure: The frequency of HDV in certain regions of Southern Anatolia
timeFrame: 01.04.2024-30.09.2024
Secondary outcomes:
measure: The rate of HIV and HCV co-infection in HDV positive patients
timeFrame: 01.04.2024-30.09.2024
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Guven Hospital
city: Diyarbakır
country: Turkey
facility: Dicle University, Faculty of Medicine
Study officials:
affiliation: Dicle University, Medical Faculty, Department of Infectious Diseases
name: Mustafa Kemal Çelen, MD
role: PRINCIPAL_INVESTIGATOR
References: