Ten‐year follow‐up of a randomized controlled clinical trial in chronic hepatitis delta
| Autor: | Michael P. Manns, Fehmi Tabak, Frank Lammert, Markus Cornberg, George N. Dalekos, Kendal Yalcin, Tobias Müller, Svenja Hardtke, Ramazan Idilman, Heiner Wedemeyer, Cihan Yurdaydin, Yilmaz Cakaloglu, Ulus Salih Akarca, M. Wöbse, A. Wranke, Dieter Häussinger, Benjamin Heidrich, Selim Gürel |
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| Přispěvatelé: | Bursa Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı., Gürel, Selim, EYK-5719-2022, Yurdaydın, Cihan, Wranke, Anika, Hardtke, Svenja, Heidrich, Benjamin, Dalekos, George, Yalçın, Kendal, Tabak, Fehmi, Çakaloğlu, Yılmaz, Akarca, Ulus S., Lammert, Frank, Haeussinger, Dieter, Mueller, Tobias, Woebse, Michael, Manns, Michael P., İdilman, Ramazan, Cornberg, Markus, Wedemeyer, Heiner, School of Medicine, Ege Üniversitesi, Dicle Üniversitesi, Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü, İç Hastalıklar Ana Bilim Dalı, Gastroenteroloji Bilim Dalı |
| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_treatment Gamma glutamyl transferase blood level Liver transplantation Gastroenterology Albumin blood level Virus-RNA law.invention Medicine Gastroenterology and hepatology Infectious diseases Virology Delta virus 0302 clinical medicine Pegylated interferon Adefovir Adefovir dipivoxil Treatment outcome Interferon therapy Clinical outcome Flares Retrospective study Randomized controlled trial Creatinine 030211 gastroenterology & hepatology Infection Human medicine.medical_specialty Recombinant protein Gamma glutamyltransferase Virus RNA Hepatitis chronic Treatment refusal Major clinical study Aspartate aminotransferase Article Treatment duration 03 medical and health sciences Alkaline phosphatase Humans Creatinine blood level endpoint Follow up Endpoint medicine.disease Event free survival Retrospective studies Alkaline phosphatase blood level Child Pugh score Gastroenterology & hepatology Aspartate aminotransferase blood level Medizin clinical outcome Need Liver disease law Prevalence delta virus 030212 general & internal medicine Chronic hepatitis Priority journal Recombinant proteins Polyethylene glycols Delta agent hepatitis Hepatitis D Death Combination drug therapy Infectious Diseases Hepatitis B surface antigen Alanine aminotransferase blood level Female chronic hepatitis Viral hepatitis Liver cancer medicine.drug Adult Treatment withdrawal End stage liver disease Drug therapy combination Peginterferon alpha2a Follow-up studies Decompensated liver cirrhosis General condition improvement Internal medicine medicine Antivirus agent Survival rate Bilirubin blood level Hepatology business.industry Albumin Bilirubin Alpha-2b Hepatitis Delta Virus Chronic Hepatitis D Hepatitis B Kinetics Antiviral agents Severity of illness index Macrogol Alanine aminotransferase business Controlled study |
| Zdroj: | Journal of Viral Hepatitis |
| ISSN: | 1365-2893 1352-0504 |
| DOI: | 10.1111/jvh.13366 |
| Popis: | Hepatitis delta virus (HDV) infection causes the most severe form of viral hepatitis. PEG-interferon alpha-2a (PEG-IFN alpha-2a) is the only effective treatment but its long-term clinical impact is unclear. the aim of this study was to investigate the long-term outcome after 48 weeks of pegylated interferon alpha-2a therapy. We performed a retrospective follow-up study of the Hep-Net-International-Delta-Hepatitis-Intervention-Study 1 (HIDIT-I trial). Patients had received 48 weeks of treatment with either PEG-IFN alpha-2a plus adefovir dipivoxil (ADV) (Group I), PEG-IFN alpha-2a alone (Group II) or adefovir dipivoxil alone (Group III). Liver-related complications were defined as liver-related death, liver transplantation, liver cancer and hepatic decompensation defined as development of Child-Pugh scores B or C or an increase in Model for End-stage Liver Disease (MELD) scores of five or more points in relation to baseline values. Patients were considered for further analysis when they were retreated with PEG-IFN alpha-2a. Follow-up data (at least 1 visit beyond post-treatment week 24) were available for 60 patients [Group I, (n = 19), Group II (n = 20), Group III (n = 21)]. Mean time of follow-up was 8.9 (1.6 - 13.4) years. 19 patients were retreated with IFN-based therapy: 42% (n = 8) in PEG-IFN alpha-2a arms and 58% (n = 11) in the adefovir only arm. Clinical complications on long-term follow-up occurred in 17 patients and were associated with nonresponse to therapy and baseline cirrhosis. the annual event-free survival rate in patients with cirrhosis vs noncirrhotic patients at year 5 and 10 was 70% vs 91% and 35% vs 76%. Long-term follow-up of a large randomized clinical trial suggests that off-treatment HDV RNA response to PEG-IFN alpha-2a treatment leads to improved clinical long-term outcome. German Centre for Infection Research (DZIF), partner site Hannover-Braunschweig; German Liver Foundation; EASL registry grant This study was funded by the German Centre for Infection Research (DZIF), partner site Hannover-Braunschweig with a grand to the HepNet Study-House, the German Liver Foundation and an EASL registry grant. |
| Databáze: | OpenAIRE |
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