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3 results on '"Çakaloğlu, Yılmaz"'

1. Pegylated interferon-based treatment in patients with advanced liver disease due to chronic delta hepatitis.

Author

Kabaçam G, Dalekos GN, Çakaloğlu Y, Zachou K, Bock T, Erhardt A, Zeuzem S, Tabak F, Yalçin K, Bozdayi AM, Dienes HP, Bozkaya H, Manns M, Wedemeyer H, and Yurdaydin C

Subjects
Adolescent, Adult, Aged, Antiviral Agents administration & dosage, Biopsy, Dose-Response Relationship, Drug, Hepatitis D, Chronic complications, Hepatitis D, Chronic virology, Hepatitis Delta Virus genetics, Humans, Liver Cirrhosis etiology, Liver Cirrhosis pathology, Middle Aged, RNA, Viral genetics, Recombinant Proteins administration & dosage, Treatment Outcome, Young Adult, Hepatitis D, Chronic drug therapy, Interferon-alpha administration & dosage, Liver pathology, Liver Cirrhosis drug therapy, Polyethylene Glycols administration & dosage
Abstract

Background/aims: The safety and efficacy of interferons in advanced delta hepatitis have not been explored. The aim of this subanalysis of a multicenter clinical trial was to compare the efficacy and safety of 48 weeks of pegylated interferon alpha-2a (180 μg weekly) with or without adefovir (10 mg daily) in patients with chronic delta hepatitis-induced advanced liver disease and in those with non-advanced liver disease., Materials and Methods: Thirty-one patients with advanced and 27 patients with non-advanced liver disease were assessed. Patients were considered to have advanced liver disease when biopsy disclosed a fibrosis score of ≥4 according to Ishak or when imaging studies were indicative of cirrhosis. Virologic response, defined as achievement of undetectable hepatitis D virus RNA, was assessed at the end of treatment and end of 24 weeks of treatment-free follow-up., Results: Patients with advanced disease had lower hepatitis D virus RNA levels and platelet counts (p=0.014 and p=0.0015, respectively). End of treatment and end of follow-up virologic responses in patients with advanced vs. non-advanced liver disease were similar (29% vs. 19% and 32% vs 23%). Proportion of adverse events did not differ between groups except that thrombocytopenia was noted more often in the advanced liver disease group. Further, four cases of clinically important adverse events including two cases of hepatic decompensation and one case of tuberculosis reactivation occurred in the advanced liver disease group., Conclusions: Pegylated interferon is as effective in patients with advanced liver disease due to chronic delta hepatitis as in patients with non-advanced liver disease, but patients should be monitored closely for clinically important side effects.

Published
2012
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2. Renal function during treatment with adefovir plus peginterferon alfa-2a vs either drug alone in hepatitis B/D co-infection

Author

Mederacke, Ingmar, Yurdaydın, Cihan, Grosshennig, Anika, Erhardt, Andreas, Çakaloğlu, Yılmaz, Yalçın, Kendal, Zeuzem, Stefan, Zachou, Kalliopi, Chatzikyrkou, Christos, Bozkaya, Hakan, Dalekos, George Nikolaos, Manns, Michael Peter, Wedemeyer, Heiner, Uludağ Üniversitesi/Tıp Fakültesi., and Gürel, Selim

Subjects
Male, Equation, Hepatitis b, Kidney, Hepatitis d, Mixed infection, Middle aged, Priority journal, Recombinant proteins, Polyethylene glycols, virus diseases, Aleutian mink disease virus, Delta agent hepatitis, Multicenter study, Management, Serum creatinine, Retrospective study, Cirrhosis, Glomerular-filtration-rate, Lamivudine, Randomized controlled trial, Combination, Glomerulus filtration rate, Infectious diseases, Interferon, Female, Glomerular filtration rate, Safety, Hepatitis B E Antigen, Entecavir, Telbivudine, Human, Adult, Adolescent, Drug therapy, combination, Peginterferon alpha2a, Adefovir, Major clinical study, Article, Kidney function, Virology, Phosphonic acids, Humans, Combination therapy, Delta-virus-infection, Aged, Adenine, Interferon-alpha, Monotherapy, Retrospective studies, Drug efficacy, Antiviral agents, Young adult, Therapy, Prediction, Gastroenterology & hepatology, Controlled study, Renal function
Abstract

Long-term safety of treatment with hepatitis B virus (HBV) polymerase inhibitors is a concern. Adefovir dipivoxil (ADV) therapy has previously been associated with impairment of renal function. Limited data are available on the safety of combination therapy with nucleos(t)ide analogues and interferon alfa (IFNa). The aim of this analysis was to assess the renal function during combination therapy with peginterferon alfa-2a (PegIFNa-2a) plus ADV vs either drug alone in patients with hepatitis B/D co-infection. We performed a retrospective analysis of renal function data of patients treated in the Hep-Net/International Delta Hepatitis Intervention Trial 1(HIDIT-1-trial), a European multicenter study to investigate the efficacy of 48 weeks of therapy with PegIFNa-2a+ADV vs either drug alone in 90 patients with chronic hepatitis B/D co-infection. Glomerular filtration rates (GFR) were calculated by CockcroftGault (CG), abbreviated Modification of Diet in Renal Disease (MDRD) study and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. After 48 weeks of therapy GFR values were significantly lower in patients receiving adefovir-containing treatment vs PegIFNa-2a alone [mean difference 16.1 mL/min (CG) and 10.2 mL/min (MDRD), respectively, P < 0.05] while no differences were observed between patients receiving adefovir alone vs combination treatment. Twenty-four weeks after treatment GFR values did not differ between treatment arms. A decrease in GFR =20% was observed more often in patients during adefovir-containing treatment vs PegIFNa-2a alone (P < 0.05) which was confirmed by KaplanMeier analysis. Adefovir-containing but not PegIFNa-2a treatment was associated with a decrease in GFR values in about one-fifth of patients. Combination treatment of PegIFNa-2a+ADV in chronic hepatitis B/D co-infection did not lead to any further impairment of kidney function. Hep-Net Study House Federal Ministry of Education & Research (BMBF) Hoffmann-La Roche Gilead Sciences

Published
2012

3. Ten‐year follow‐up of a randomized controlled clinical trial in chronic hepatitis delta

Author

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, 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, and Dicle Üniversitesi, Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü, İç Hastalıklar Ana Bilim Dalı, Gastroenteroloji Bilim Dalı

Subjects
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
Abstract

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.

Published
2020
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