Diversity of clinical presentation and virological characteristics of hepatitis delta in different regions world-wide: Results of the Hepatitis Delta International network (HDIN)
Anika Wranke , Svenja Hardtke* , Lourdes M. Pinheiro Borzacov, Raimundo Parana; Cirley Lobato, Saeed Hamid, Emanoil Ceausu, George N. Dalekos, Mario Rizzetto, Adela Turcanu, Grazia Niro, Tonya Hayden,Farheen Lubna, Minaam Abbas Patrick Ingiliz, Maria Buti, Peter FerenciThomas Vanwolleghem, Adriana Motoc, Zaigham Abbas, Cihan Yurdaydin, Michael P. Manns, Heiner Wedemeyeron behalf of The Hepatitis Delta International Network
Background and Aims:
Chronic delta hepatitis represents a major global health burden. Clinical features of HDV infection vary largely between different regions world-wide. Moreover, treatment approaches may differ and depend on financial resources. However, factors determining disease progression are poorly defined. The Hepatitis Delta International network (HDIN) was established in 2011 to establish a comprehensive database to facilitate clinical research on chronic hepatitis delta.
The HDIN registry was developed by the HepNet Study-House of the German Liver Foundation in collaboration with researchers from Europe, Asia, North and South America. A structured eCRF specifically developed for hepatitis delta was implemented. A central data monitoring process has been established. Currently, 19 centers in 15 countries are participating. We here report data of 1306 patients with ongoing or past HDV infection included until October 1st 2016.
The majority of patients was male (n=979, 62%) and the mean age was 36.7 years including 9% of patients being younger than 20 years and 18% being older than 50 years. Most patients were HBeAg-negative (77%) and HDV RNA positive (85%). Liver cirrhosis was reported in 38% of cases. The overall severity of HDV infection was confirmed by low platelet counts (<100.000/µl) and high INR values in one quarter of patients. Previous liver decompensation was described in 13% of cases. Hepatocellular carcinoma developed in only 30 patients (2.5%) and 44 patients (3.6%) underwent liver transplantation. Patients were divided according to the country of birth into Eastern Mediterranean (EM; 10%), Eastern Europe and Central Asia (EE; 43%), Central and Southern Europe (CE; 6%), South Asian (SAS, 25%) and South America (SA; 12%). Clinical liver-related endpoints were reported most frequently in SA patients (30%) who also had a highest frequency of increased INR values (70%). In contrast, SAS patients had lowest albumin levels while CE patients were older. Antiviral therapy was administered to 356 patients (highst treatment uptake in CE patients, lowest in SAS), including 264 patients being treated with IFNa and 92 patients who were treated with HBV-Nucs only.
Conclusions: The HDIN registry highlights the diversity of patient characteristics in different regions world-wide and confirms the particular severity of hepatitis delta. There is an urgent need for novel treatment options for HDV infection.