Person: GÜREL, SELİM
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GÜREL
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SELİM
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Publication Real-world efficacy and safety of Ledipasvir plus Sofosbuvir and Ombitasvir/Paritaprevir/Ritonavir ± Dasabuvir combination therapies for chronic hepatitis C: A Turkish experience(Aves, 2020-10-09) Değertekin, Bülent; Demir, Mehmet; Akarca, Ulus S.; Kani, Haluk Tarık; Üçbilek, Enver; Yıldırım, Emre; Güzelbulut, Fatih; Balkan, Ayhan; Vatansever, Sezgin; Danış, Nilay; Demircan, Melek; Soylu, Aliye; Yaras, Serkan; Kartal, Aysun; Kefeli, Ayşe; Gündüz, Feyza; Yalçın, Kendal; Erarslan, Elife; Aladağ, Murat; Harputluoğlu, Murat; Özakyol, Ayşegül; Temel, Tuncer; Akarsu, Mesut; Sümer, Hale; Akın, Mete; Albayrak, Bülent; Şen, İlker; Alkim, Hüseyin; Uyanıkoğlu, Ahmet; Irak, Kader; Öztaşkın, Sinem; Uğurlu, Çağrı Burak; Güneş, Şevkican; Gürel, Selim; Nuriyev, Kenan; İnci, İsmail; Kaçar, Sabite; Dinçer, Dinç; Doğanay, Levent; Göktürk, Hüseyin Savaş; Mert, Ali; Coşar, Arif Mansur; Dursun, Hakan; Atalay, Roni; Akbulut, Sabiye; Balkan, Yasemin; Koklu, Hayrettin; Şimşek, Halis; Özdoğan, Osman; Çoban, Mehmet; Poturoğlu, Şule; Ayyıldız, Talat; Yapalı, Suna; Günşar, Fulya; Akdoğan, Meral; Özenirler, Seren; Akyıldız, Murat; Sezgin, Orhan; Özdoğan, Osman; Kaymakoğlu, Sabahattin; Besişik, Fatih; Karasu, Zeki; Idılman, Ramazan; GÜREL, SELİM; Bursa Uludağ Üniversitesi/Tıp Fakültesi/Gastroenteroloji ve Hepatoloji Anabilim Dalı.; 0000-0002-7279-2161; HLH-8209-2023Background/Aims: This study aimed to evaluate the real-life efficacy and tolerability of direct-acting antiviral treatments for patients with chronic hepatitis C (CHC) with/without cirrhosis in the Turkish population.Material and Methods: A total of 4,352 patients with CHC from 36 different institutions in Turkey were enrolled. They received ledipasvir (LDV) and sofosbuvir (SOF)+/- ribavirin (RBV) ombitasvir/paritaprevir/ritonavir +/- dasabuvir (PrOD)+/- RBV for 12 or 24 weeks. Sustained virologic response (SVR) rates, factors affecting SVR, safety profile, and hepatocellular cancer (HCC) occurrence were analyzed.Results: SVR12 was achieved in 92.8% of the patients (4,040/4,352) according to intention-to-treat and in 98.3% of the patients (4,040/4,108) according to per-protocol analysis. The SVR12 rates were similar between the treatment regimens (97.2%-100%) and genotypes (95.6%-100%). Patients achieving SVR showed a significant decrease in the mean serum alanine transaminase (ALT) levels (50.90 +/- 54.60 U/L to 17.00 +/- 14.50 U/L) and model for end-stage liver disease (MELD) scores (7.51 +/- 4.54 to 7.32 +/- 3.40) (p<0.05). Of the patients, 2 were diagnosed with HCC during the treatment and 14 were diagnosed with HCC 37.0 +/- 16.0 weeks post-treatment. Higher initial MELD score (odds ratio [OR]: 1.92, 95% confidence interval [CI]: 1.22-2.38; p=0.023]), higher hepatitis C virus (HCV) RNA levels (OR: 1.44, 95% CI: 1.31-2.28; p=0.038), and higher serum ALT levels (OR: 1.38, 95% CI: 1.21-1.83; p=0.042) were associated with poor SVR12. The most common adverse events were fatigue (12.6%), pruritis (7.3%), increased serum ALT (4.7%) and bilirubin (3.8%) levels, and anemia (3.1%).Conclusion: LDV/SOF or PrOD +/- RBV were effective and tolerable treatments for patients with CHC and with or without advanced liver disease before and after liver transplantation. Although HCV eradication improves the liver function, there is a risk of developing HCC.Publication A transient early hbv-dna increase during peg-ifnα therapy of hepatitis d indicates loss of infected cells and is associated with hdv-rna and hbsag reduction(Wiley, 2020-12-12) Anastasiou, Olympia E.; Yurdaydin, Cihan; Maasoumy, Benjamin; Hardtke, Svenja; Caruntu, Florin Alexandru; Curescu, Manuela G.; Yalcin, Kendal; Akarca, Ulus S.; Zeuzem, Stefan; Erhardt, Andreas; Luth, Stefan; Papatheodoridis, George, V; Radu, Monica; Liebig, Stephanie; Bantel, Heike; Bremer, Birgit; Manns, Michael P.; Cornberg, Markus; Wedemeyer, Heiner; Gürel, Selim; GÜREL, SELİM; Bursa Uludağ Üniversitesi/Tıp Fakültesi; HLH-8209-2023HBV-DNA levels are low or even undetectable in the majority HDV-infected patients. The impact of PEG-IFN alpha on HBV-DNA kinetics in HDV-infected patients has not been studied in detail. We analysed data of a prospective treatment trial where 120 HDV-RNA-positive patients were randomized to receive PEG-IFN alpha-2a plus tenofovir-disoproxil-fumarate (PEG-IFN alpha/TDF, n = 59) or placebo (PEG-IFN alpha/PBO; n = 61) for 96 weeks. At week 96, HBV-DNA was still quantifiable in 71% of PEG-IFN alpha/PBO-treated patients but also in 76% of PEG-IFN alpha/TDF-treated patients, despite low HBV-DNA baseline values. Surprisingly, a transient HBV-DNA increase between weeks 12 and 36 was observed in 12 in PEG-IFN alpha/TDF-treated and 12 PEG-IFN alpha/PBO-treated patients. This increase was positively associated with HBsAg loss [(P = 0.049, odds ratio (OR) 5.1] and HDV-RNA suppression (P = 0.007, OR 4.1) at week 96. Biochemical markers of cell death (M30 and ALT) were higher during the HBV-DNA peak but no distinct systemic immune pattern could be observed by screening 91 soluble inflammatory markers. In conclusion, an early increase in HBV-DNA during PEG-IFN alpha-2a therapy occurred in more than 20% of patients, even in TDF-treated patients. This transient HBV-DNA rise may indicate PEG-IFN alpha-induced cell death and lead to long-term HDV-RNA suppression and HBsAg loss.Publication Residual low hdv viremia is associated with hdv rna relapse after peg-ifna-based antiviral treatment of hepatitis d (delta): Results from the hidit-ii study(Elsevier, 2020-08-01) Bremer, Birgit; Anastasiou, Olympia; Hardtke, Svenja; Caruntu, Florin Alexandru; Curescu, Manuela Gabriela; Yalcin, Kendal; Akarca, Ulus S.; Idilman, Ramazan; Zeuzem, Stefan; Erhardt, Andreas; Lueth, Stefan; Papatheodoridis, George; Radu, Monica; Manns, Michael P.; Cornberg, Markus; Yurdaydın, Cihan; Wedemeyer, Heiner; Gürel, Selim; GÜREL, SELİM; Bursa Uludağ Üniversitesi/Tıp Fakültesi.; HLH-8209-2023Publication Association between ALT flares and HBeAg loss and HBsAg decline in Patients with Chronic Hepatitis B during treatment with Tenofovir Disoproxil Fumarate or Adefovir Dipivoxil(Lippincott Williams & Wilkins, 2015-10-01) Marcellin, Patrick; Gane, Edward J.; Krastev, Zahary; Gürel, Selim; Dusheiko, Geoffrey M.; Gaggar, Anuj; Massetto, Benedetta; Kim, Kyungpil; Flaherty, John F.; Subramanian, Mani; Janssen, Harry L.; Buti, Maria; GÜREL, SELİM; Uludağ Üniversitesi/Tıp Fakültesi.; HLH-8209-2023Publication HCC risk scores: Application of the CU-HCC, GAG-HCC and page-B scores to chronic hepatitis B (CHB) patients treated with tenofovir disoproxil fumarate (TDF)(Elsevier Science, 2015-04-01) Kim, W. R.; Loomba, R.; Berg, T.; Schall, R. Aguilar; Yee, L.; Dinh, P.; Flaherty, J. F.; Martins, E. B.; Jacobson, I.; Fung, S.; Gürel, S.; Buti, M.; Marcellin, P.; GÜREL, SELİM; Uludağ Üniversitesi/Tıp Fakültesi/Gastroenteroloji Anabilim Dalı.; HLH-8209-2023Publication Mean platelet volume is an important predictor of hepatitis c but not hepatitis b liver damage(Wolters Kluwer Medknow Publications, 2015-09-01) Eminler, Ahmet Tarık; Uslan, Mustafa Ihsan; Ayyıldız, Talat; Irak, Kader; Kıyıcı, Murat; KIYICI, MURAT; Gürel, Selim; GÜREL, SELİM; Dolar, Enver; DOLAR, MAHMUT ENVER; Gülten, Macit; GÜLTEN, MACİT; Nak, Selim Giray; NAK, SELİM GİRAY; Bursa Uludağ Üniversitesi/Tıp Fakültesi/Gastroenteroloji Anabilim Dalı.; 0000-0002-0019-3207; 0000-0002-3208-6211; ABF-1568-2021; HLH-8209-2023; AAI-4213-2021; AAG-9177-2021Background: The mean platelet volume (MPV) is the most commonly used measure of platelet size and is a potential marker of platelet reactivity. In this study, we aimed to explore the relationship between hepatic histopathology in viral hepatitis and MPV levels, which are associated with platelet count and activity. Materials and Methods: We performed a retrospective case-control study of baseline histological and clinical parameters in chronic hepatitis B and C patients in our tertiary reference center between January 2005 and January 2011. Two hundred and five chronic hepatitis B patients and 133 chronic hepatitis C patients who underwent liver biopsy were included in the study. The patients were divided into two groups: Chronic hepatitis B and chronic hepatitis C and were additionally divided into groups of two according to histological activity index (HAI) and fibrosis scores obtained by liver biopsy results (according to the Ishak scoring system). The clinical characteristics of chronic viral hepatitis patients, including demographics, laboratory (especially MPV), and liver biopsy findings, were reviewed. Results: One hundred and forty-three patients were male (69.1%), and the mean age was 41.9 +/- 12.75 with an age range of 18-71 years in hepatitis B patients. In the classification made according to HAI, 181 patients were in the low activity group (88.3%) and 24 in the high activity group (11.7%). In the evaluation made according to fibrosis score, 169 patients were found to have early fibrosis (82.4%) and 36 were found to have advanced fibrosis (17.6%). In patients with hepatitis B, there was no statistically significant difference in terms of their MPV values between the two groups, separated according to their degree of activity and fibrosis. Sixty-three patients were male (47.3%), and the mean age was 50.03 +/- 12.75 with an age range of 19-75 years. In the classification made according to HAI, 109 patients were in low activity group (81.9%) and 24 in high activity group (18.1%). In the evaluation made according to fibrosis score, 101 patients were found to have early fibrosis (75.9%) and 32 have advanced fibrosis (24.1%). There was a statistically significant difference between the activity and fibrosis groups of the hepatitis C patients (P = 0.04 and P = 0.02, respectively). Conclusion: MPV values are more reliable in hepatitis C patients than hepatitis B for predicting the advanced damage in liver histology. This finding might be useful for the detection of early fibrosis and also starting early treatment, which is important in hepatitis C.Publication Long term treatment with tenofovir disoproxil fumarate for chronic hepatitis b infection is safe and well tolerated and associated with durable virologic response with no detectable resistance: 8 year results from two phase 3 trials(Wiley, 2014-01-01) Marcellin, Patrick; Gane, Edward J.; Flisiak, Robert; Trinh, Huy N.; Petersen, Joerg; Gürel, Selim; Kaita, Kelly D.; Kotzev, Iskren A.; Tsai, Naoky; Flaherty, John F.; Schall, Raul E. Aguilar; Kitrinos, Kathryn M.; Subramanian, Mani; McHutchison, John G.; George, Jacob; Janssen, Harry L.; Buti, Maria; GÜREL, SELİM; Uludağ Üniversitesi/Tıp Fakültesi; HLH-8209-2023Publication Prolonged therapy of hepatitis delta for 96 weeks with pegylated-interferon-α-2a plus tenofovir or placebo does not prevent hdv rna relapse after treatment: The hidit-2 study(Elsevier, 2014-04-01) Wedemeyer, H.; Yurdaydin, C.; Ernst, S.; Caruntu, F. A.; Curescu, M. G.; Yalcin, K.; Akarca, U. S.; Gürel, Selim; Zeuzem, S.; Erhardt, A.; Lueth, S.; Papatheodoridis, G. V.; Keskin, O.; Port, K.; Radu, M.; Celen, M. K.; Ildeman, R.; Stift, J.; Heidrich, B.; Mederacke, I.; Hardtke, S.; Koch, A.; Dienes, H. P.; Manns, M. P.; HIDIT-2 Study Grp; GÜREL, SELİM; Uludağ Üniversitesi/Tıp Fakültesi; HLH-8209-2023Publication Randomized comparison of tenofovir disoproxil fumarate vs emtricitabine and tenofovir disoproxil fumarate in patients with lamivudine-resistant chronic hepatitis b(W B Saunders Co-Elsevier Inc, 2014-04-01) Fung, Scott; Kwan, Peter; Fabri, Milotka; Horban, Andrzej; Pelemis, Mijomir; Hann, Hie-Won; Gürel, Selim; Caruntu, Florin A.; Flaherty, John F.; Massetto, Benedetta; Dinh, Phillip; Corsa, Amoreena; Subramanian, G. Mani; McHutchison, John G.; Husa, Petr; Gane, Edward; GÜREL, SELİM; Uludag Üniversitesi/Tıp Fakültesi.; HLH-8209-2023BACKGROUND & AIMS: Tenofovir disoproxil fumarate (TDF) is active against lamivudine-resistant hepatitis B virus (HBV) infection, but data to support its clinical efficacy in this setting are limited.METHODS: In a prospective, double-blind, 96-week trial, patients were randomly assigned (1:1) to groups given TDF (300 mg, n = 141) or a combination of emtricitabine (FTC, 200 mg; n 139) and TDF (300 mg, FTC/TDF). Patients were hepatitis B e antigen (HBeAg) - positive or HBeAg-negative, with levels of HBV DNA >= 3 log10 IU/mL and lamivudine resistance mutations (HBV polymerase or reverse transcriptase amino acid substitutions rtM204I/V +/- rtL180M by INNO-LiPA Multi-DR v3; Innogenetics, Inc, Alpharetta, GA). The primary end point was proportion with HBV DNA <69 IU/mL (Roche COBAS Taqman assay; Roche Molecular Systems, Inc, Pleasanton, CA).RESULTS: Patient groups were well matched for demographic and disease characteristics, including region (60% from Europe), HBV genotype (45% genotype D), HBeAg status (47% HBeAg-positive), and duration of lamivudine treatment (mean, 3.8 years). At week 96 of treatment, 89.4% of patients in the TDF group and 86.3% in the FTC/TDF group had levels of HBV DNA <69 IU/mL (P = .43). HBeAg loss and seroconversion did not differ between groups; only 1 patient (0.7%) in the FTC/TDF group lost hepatitis B surface antigen. Treatment was well tolerated; confirmed renal events (creatinine increase of >= 0.5 mg/dL [>44 umol/L], creatinine clearance <50 mL/min, or level of PO4 <2 mg/dL [<0.65 mmol/L]) were generally mild and infrequent (<1%). Small reductions (<2%) in mean bone mineral density of hip and spine were detected by dual-energy x-ray absorptiometry in both groups. No TDF resistance developed through 96 weeks of treatment.CONCLUSIONS: TDF alone is safe and effective for treatment of patients with lamivudine-resistant, chronic HBV infection. Clinical Trials.gov No, NCT00737568.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.
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