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-8209-2023