Burden of Hepatitis D Virus (HDV) Infection in Italy

Study Overview
=================
Brief Summary
-----------------
The circulation of the Hepatitis D Virus (HDV) has considerably diminished in Italy, secondary to the control of the Hepatitis B Virus (HBV) with vaccination; this has led to the perception that HDV is vanishing and has reduced attention to the diagnosis of Hepatitis D. However, migratory fluxes from HDV endemic areas, fostered by labour-forces globalization, are increasingly reconstituting the reservoir of HDV in the country and hepatitis D has not yet vanished in native Italians but will remain an important medical issue for several years to come. As the epidemiologic and clinical features of HDV infection in migrant communities are largely unknown and the features of native Italians with long standing HDV infections have not been updated, this project intends to establish the contemporary epidemiological and medical context of HDV in immigrants in Italy and to determine the clinical characteristics and needs of the residual cohort of native HDV Italians, through the analysis of all HDV cases recruited in 12 months in a coordinated network of 35 Italian medical centers. The data will provide an appraisal of the burden of hepatitis D in the country and of its impact on the National Health System. They will present the paradigm of the current trend of HDV infection in high-income countries in the world.

Official Title
-----------------
Burden of Hepatitis D Virus (HDV) Infection in Italy: a Prospective/Observational Multicenter Study to Define Demographic, Clinical and Virological Features

Conditions
-----------------
Chronic Hepatitis D

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HBsAg-positive subjects 18 years or older anti-HD-positive

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with chronic hepatitis D<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic characteristics of HDV-infected patients | Demographic characteristics: age, sex, height, weight, nationality. HDV means hepatitis D virus | 1 year | 
| Epidemiologic characteristics of HDV-infected patients | Risk factors for infection. HDV means hepatitis D virus | 1 year | 
| Serum alanine aminotransferase concentration values in HDV-infected patients | HDV means hepatitis D virus | 1 year | 
| Blood platelet count in HDV-infected patients | HDV means hepatitis D virus | 1 year | 
| Serum albumin concentration values in HDV-infected patients | HDV means hepatitis D virus | 1 year | 
| Serum total bilirubin concentration values in HDV-infected patients | HDV means hepatitis D virus | 1 year | 
| Serum anti-liver-kidney microsomal antibodies titer in HDV-infected patients | HDV means hepatitis D virus | 1 year | 
| Proportion of patients with detectable HDV RNA among seropositive anti-HDV patients | HDV means hepatitis D virus | 1 year | 
| Serum HDV RNA levels in HDV-infected patients | HDV means hepatitis D virus | 1 year | 
| Proportion of HDV genotypes among patients with detectable HDV RNA | HDV means hepatitis D virus | 1 year | 
| Proportion of patients with detectable HBV DNA among seropositive anti-HDV | HBV means hepatitis B virus. HDV means hepatitis D virus | 1 year | 
| Serum HBV DNA levels in HDV-infected patients | HBV means hepatitis B virus. HDV means hepatitis D virus | 1 year | 
| Proportion of HBV genotypes among patients with detectable HBV DNA | HBV means hepatitis B virus | 1 year | 
| HBsAg concentration levels in HDV-infected patients | HBsAg means hepatitis B surface antigen. HDV means hepatitis D virus | 1 year | 
| HBcrAg concentration levels in HDV-infected patients | HBcrAg means hepatitis B core-related antigen. HDV means hepatitis D virus | 1 year | 
| Proportion of patients with liver cirrhosis among seropositive anti-HDV | HDV means hepatitis D virus | 1 year | 
| Liver stiffness values in HDV-infected patients | HDV means hepatitis D virus | 1 year | 
| Proportion of patients with hepatocellular carcinoma among seropositive anti-HDV | HDV means hepatitis D virus | 1 year | 
| Proportion of patients treated with antiviral therapy among seropositive anti-HDV | HDV means hepatitis D virus | 1 year |