Browsing by Author "Tabak, Fehmi"
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Item Association between level of hepatitis d virus RNA at week 24 of pegylated interferon therapy and outcome(Elsevier, 2015-12) Keskin, Onur; Wedemeyer, Heiner; Tüzün, Ali; Zachou, Kalliopi; Deda, Xheni; Dalekos, George N.; Heidrich, Benjamin; Pehlivan, Selcen; Zeuzem, Stefan; Yalçın, Kendal; Tabak, Fehmi; İdilman, Ramazan; Bozkaya, Hakan; Manns, Michael; Yurdaydın, Cihan; Gürel, Selim; Uludağ Üniversitesi/Tıp Fakültesi/Gastroenteroloji Anabilim Dalı.; 7003706434BACKGROUND & AIMS: Interferon is the only effective treatment for chronic hepatitis D virus (HDV) infection. No rules have been set for stopping treatment based on viral kinetics. We analyzed data from an international study of hepatitis D treatment to identify factors associated with outcomes of pegylated interferon treatment, with and without adefovir. METHODS: We analyzed data from the Hep-Net-International Delta Hepatitis Intervention Trial on 50 patients with compensated liver disease who tested positive for anti-HDV and HDV RNA. Subjects received pegylated interferon alpha 2a, with adefovir or placebo, or only adefovir, for 48 weeks. Twenty-four weeks after treatment ended, 41 patients were evaluated for levels of HDV RNA and DNA, liver enzymes, and hepatitis B surface antigen (HBsAg); liver biopsy specimens were analyzed for fibrosis. Response to therapy was defined as end-of-treatment response or post-treatment week 24 virologic response. In both cases virologic response was associated with undetectable HDV RNA levels. Patients with less than a 1 log decrease in HDV RNA at the end of treatment were considered null responders. RESULTS: Based on univariate and multivariate analysis, the level of HDV RNA at week 24 of treatment was associated more strongly with response to therapy than other factors analyzed. The level of HBsAg at week 24 of treatment was associated with a response to therapy only in univariate analysis. Lack of HDV RNA at week 24 of treatment, or end of treatment, identified responders with positive predicted values of 71% and 100%, respectively. At 24 weeks after treatment, a decrease in HDV RNA level of less than 1 log, combined with no decrease in HBsAg level, identified null responders with a positive predictive value of 83%. A decrease in HDV RNA level of more than 2 log at week 24 of treatment identified null responders with a negative predictive value of 95%. CONCLUSIONS: Based on an analysis of data from a large clinical trial, the level of HDV RNA at week 24 of treatment with pegylated interferon, with or without adefovir for 48 weeks, can identify patients who will test negative for HDV RNA 24 weeks after the end of treatment. This information can be used to help physicians manage patients receiving therapy for chronic hepatitis D.Publication Demographic characteristics and transmission risk factors of patients with hepatitis c virus in Turkey: The EPI-C, a multicenter and cross-sectional trial(Galenos Yayıncılık, 2021-09-21) Tabak, Fehmi; Şirin, Göktuğ; Demir, Mehmet; Aladağ, Murat; Sümer, Sua; Kurtaran, Behice; Tosun, Selma; Yamazhan, Tansu; Bozkurt, İlkay; Gürbüz, Yunus; Batirel, Ayşe; Senateş, Ebubekir; Kandemir, Fatma Özlem; Topal, Firdevs; Doğanay, Hamdi Levent; Sezgin, Orhan; Mıstık, Reşit; Köse, Sükran; Yılmaz, Yusuf; İnan, Dilara; Köksal, İftihar; Parlak, Emine; Akdoğan, Meral; Güner, Rahmet; Mıstık, Reşit; Bursa Uludağ Üniversitesi/Tıp Fakültesi/Enfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Kliniği.; 0000-0002-1548-8526; DFY-3761-2022Objectives: To describe the prevalence of risk factors in patients infected with hepatitis C virus (HCV).Materials and Methods: Patients who were aged >18 years visiting outpatient clinics and diagnosed as having HCV infection were enrolled in this cross-sectional, multicenter study conducted in 71 cities. Patient data on socio-demographic and clinical characteristics and pre-defined risk factors were collected.Results: Among 1,018 patients, 53.0% were women. The mean age was 57.2 +/- 14.3 years and 34.8% had been diagnosed as having HCV infection >10 years before enrollment. Almost half of the patients (45.5%) were diagnosed during their regular check-up visits, and only 16.8% were diagnosed because of signs or symptoms of HCV. Genotype 1 and sub-genotype 1 b were detected in 87.9% and 73.7% of the patients, respectively. At least one risk factor was present in 94.8% of the patients. The most frequently reported risk factor was major dental procedures (79.2%), followed by major surgical operations (56.9%) and minor surgical interventions (42.3%).Conclusion: Our results revealed that most of the patients with HCV infection underwent major dental procedures.Publication Late HDV RNA relapse after peginterferon alpha-based therapy of chronic hepatitis delta(Lippincott Williams & Wilkins, 2014-07-01) Heidrich, Benjamin; Yurdaydin, Cihan; Kabacam, Gokhan; Ratsch, Boris A.; Zachou, Kalliopi; Bremer, Birgit; Dalekos, George N.; Erhardt, Andreas; Tabak, Fehmi; Yalçın, Kendal; Gürel, Selim; Zeuzem, Stefan; Cornberg, Markus; Bock, C. -Thomas; Manns, Michael P.; Wedemeyer, Heiner; GÜREL, SELİM; Uludağ Üniversitesi/Tıp Fakültesi/Gastroenteroloji Anabilim Dalı.; HLH-8209-2023Interferon alpha is the only treatment option for hepatitis delta virus (HDV). Trials investigating the efficacy of pegylated interferon alpha (PEG-IFNa) showed HDV RNA negativity rates of 25-30% 24 weeks after therapy. However, the clinical and virological long-term outcome of HDV-infected patients treated with PEG-IFNa is unknown. We performed a retrospective-prospective follow-up of 77 patients treated for 48 weeks with either PEG-alfa-2a and adefovir (ADV) or either drug alone in the Hep-Net-International-Delta-Hepatitis-Intervention-Study 1 (HIDIT-1) trial. Long-term follow-up data were available for 58 out of 77 patients (75%) with a median time of follow-up of 4.5 (0.5-5.5) years and a median 3 visits per patient. Patients treated with ADV alone received retreatment with PEG-IFNa (48% versus 19%; P = 0.02) more often. Hepatitis B virus surface antigen (HBsAg) became negative in six PEG-IFNa-treated patients until the end of long-term follow-up (10%). Sixteen patients tested HDV RNA-negative 6 months after PEG-IFNa treatment who were entered in the long-term follow-up study. Out of these, nine individuals tested HDV RNA-positive at least once during further long-term follow-up, with seven patients being HDV RNA-positive at the most recent visit. Clinical endpoints (liver-related death, liver transplantation, hepatic decompensation, hepatocellular carcinoma) were observed in three PEG-IFNa-treated (8%) and three ADV-treated (14%) patients during posttreatment long-term follow-up with an overall annual event rate of 2.5% (4.9% in cirrhosis). Sequencing confirmed the reappearance of pretreatment virus strains in all cases. Conclusion: Late HDV RNA relapses may occur after PEG-IFNa therapy of hepatitis delta and thus the term sustained virological response should be avoided in HDV infection. The annual posttreatment rate of clinical events in hepatitis delta patients eligible for PEG-IFNa therapy is about 2.5% and 4.9% in patients with cirrhosis.Publication Low recurrence rate of hepatocellular carcinoma following ledipasvir and sofosbuvir treatment in a real-world chronic hepatitis C patients cohort(Wiley, 2019-06-01) İdilman, Ramazan; Demir, Mehmet; Aladağ, Murat; Erol, Cihan; Çavuş, Bilger; İliaz, Raim; Köklü, Hayrettin; Çakaloğlu, Yılmaz; Şahin, Memduh; Ersöz, Galip; Köksal, İftihar; Karasu, Zeki; Özgenel, Meriç; Turan, İlker; Gündüz, Feyza; Ataseven, Hüseyin; Akdoğan, Meral; Kıyıcı, Murat; Köksal, Aydın Şeref; Akhan, Sila; Günsar, Fülya; Tabak, Fehmi; Kaymakoglu, Sabahattin; Akarca, Ulus S.; Akarsu, Mesut; Alkim, Hüseyin; Araz, Filiz; Ateş, Fehmi; Aygen, Bilgehan; Balık, İsmail; Barut, Hüseyin S.; Baysal, Birol; Bolat, Aylin; Çelik, İlhami; Coşgun, Süleyman; Ensaroglu, Fatih; Gökcan, Hale; Gürel, Selim; Gürsoy, Şebnem; İnkaya, Ahmet Çağan; Kamilli, Cemil; Kav, Taylan; Kuruüzüm, Ziya; Önder, Fatih O.; Örmeci, Necati; Özbakır, Ömer; Özenirler, Seren; Özer, Birol; Özkan, Hasan; Poturoğlu, Şule; Senates, Ebubekir; Şimşek, Halis; Toka, Bilal; Ünal, Hakan; Yaras, Serkan; Yıldırım, Abdullah E.; Yıldırım, Beytullah; Yılmaz, Bülent; Yılmaz, Hasan; Yozgat, Ahmet; Yurdaydın, Cihan; Early Access Program EAP Study Grp; KIYICI, MURAT; Bursa Uludağ Üniversitesi/Tıp Fakültesi/Gastroenteroloji Anabilim Dalı; 0000-0002-3208-6211; AAI-4213-2021The aims of the present study were to evaluate the efficacy and tolerability of ledipasvir/sofosbuvir (LDV/SOF) with or without ribavirin in the treatment of chronic hepatitis C (CHC) in patients with advanced liver disease and to analyse whether the use of LDV/SOF treatment is associated with a new occurrence of hepatocellular carcinoma (HCC) during and after LDV/SOF treatment. The Turkish Early Access Program provided LDV/SOF treatment to a total of 200 eligible CHC patients with advanced liver disease. The median follow-up period was 22months. All patients were Caucasian, 84% were infected with genotype 1b, and 24% had a liver transplantation before treatment. The sustained virological response (SVR12) was 86.0% with ITT analysis. SVR12 was similar among patients with Child-Pugh classes A, B and C disease and transplant recipients. From baseline to SVR12, serum ALT level and MELD score were significantly improved (P<0.001). LDV/SOF treatment was generally well tolerated. Only one patient developed a new diagnosed HCC. Seventeen of the 35 patients, who had a history of previous HCC, developed HCC recurrence during the LDV/SOF treatment or by a median follow-up of 6months after treatment. HCC recurrence was less commonly observed in patients who received curative treatment for HCC compared with those patients who received noncurative treatment (P=0.007). In conclusion, LDV/SOF with or without ribavirin is an effective and tolerable treatment in CHC patients with advanced liver disease. Eradication is associated with improvements in liver function and a reduced risk of developing a new occurrence of HCC.Ledipasvir and sofosbuvir with or without ribavirin is an effective and tolerable treatment in hepatitis C virus-infected patients with advanced liver disease. Eradication is associated with improvements in liver function and reduces the risk of developing a new occurrence of hepatocellular carcinoma.Item Ten-year follow-up of a randomized controlled clinical trial in chronic hepatitis delta(Wiley, 2020-07-24) 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.; Idilman, Ramazan; Cornberg, Markus; Wedemeyer, Heiner; Yurdaydın, Cihan; Gürel, Selim; Bursa Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı.; EYK-5719-2022; 7003706434Hepatitis delta virus (HDV) infection causes the most severe form of viral hepatitis. PEG-interferon alpha-2a (PEG-IFNα-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-IFNα-2a plus adefovir dipivoxil (ADV) (Group I), PEG-IFNα-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-IFNα-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-IFNα-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-IFNα-2a treatment leads to improved clinical long-term outcome.