Browsing by Author "Çelik, İlhami"

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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-4213-2021
The 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.
Real-world data from Turkey: Is sofosbuvir/ledipasvir with or without ribavirin treatment for chronic hepatitis c really effective?
(Aves, 2021-02-01) Demirtürk, Neşe; Aygen, Bilgehan; Çelik, İlhami; Mıstık, Reşit; Akhan, Sıla; Barut, Şener; Ural, Onur; Batırel, Ayşe; Şimşek, Funda; Ersöz, Gülden; İnan, Dilara; Kınıklı, Sami; Türker, Nesrin; Bilgin, Hüseyin; Gürbüz, Yunus; Tülek, Necla; Tarakcı, Hüseyin; Yıldız, Orhan; Türkoğlu, Emine; Güzel, Deniz Kamalak; Şimşek, Sümeyra; Tuna, Nazan; Demir, Nazlım Aktuğ; Çağatay, Atahan; Çetinkaya, Rıza Aytaç; Karakeçili, Faruk; Hakyemez, İsmail Necati; Ertem, Günay Tuncer; Örmen, Bahar; Korkmaz, Pınar; Şili, Uluhan; Kuruüzüm, Ziya; Şener, Alper; Özel, Selcan Arslan; Öztürk, Sinan; Süer, Kaya; Çelen, Mustafa Kemal; Konya, Petek; Asan, Ali; Saltoğlu, Neşe; Doğan, Nurhan; Şimşek, Sümeyra; Bursa Uludağ Üniversitesi/Tıp Fakültesi/Enfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Anabilim Dalı.; DTA-4765-2022
Background: In this study, we aimed to investigate the efficacy and safety of sofosbuvir-based therapies in the treatment of chronic hepatitis C in real-world clinical practice.Methods: Data from patients with chronic hepatitis C treated with SOF/LDV +/- RBV or SOF/RBV in 31 centers across Turkey between April 1, 2017, and August 31, 2018, were recorded in a nationwide database among infectious disease specialists. Demographics, clinical, and virological outcomes were analyzed.Results: A total of 552 patients were included in the study. The mean age of the patients was 51.28 +/- 14.2, and 293 (55.8%) were female. The majority had HCV genotype 1b infection (65%), 75.04% of the patients underwent treatment, and non-cirrhosis was present at baseline in 381 patients (72.6%). SOF/LDV +/- RBV treatment was given to 477 patients and 48 patients received SOF/RBV according to HCV genotype. The total SVR12 rate was 99% in all patients. Five patients experienced disease relapse during the study and all of them were genotype 2. In patients infected with HCV GT2, SVR12 was 77.3%. SVR was 100% in all patients infected with other HCV genotypes. All treatments were well tolerated by patients without causing severe adverse events. Side effects and side effects-associated treatment discontinuation rates were 28.2% and 0.4%, respectively. Weakness (13.7%) was the common side effect.Conclusion: The present real-world data of 525 patients with HCV genotypes 1, 1a, 1b, 3, 4, and 5 who underwent SOF/LDV +/- RBV treatment in Turkey demonstrated a high efficacy and safety profile. HCV GT2 patients should be treated with more efficacious treatment.
Real-world efficacy, safety, and clinical outcomes of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin combination therapy in patients with hepatitis C virus genotype 1 or 4 infection: The Turkey experience experience
(AVES, 2020-04) Aygen, Bilgehan; Demirtürk, Neşe; Yıldız, Orhan; Çelen, Mustafa Kemal; Çelik, İlhami; Barut, Şener; Ural, Onur; Batırel, Ayşe; Şimşek, Funda; Aşan, Ali; Ersöz, Gülden; Türker, Nesrin; Bilgin, Hüseyin; Kınıklı, Sami; Karakeçili, Faruk; Zararsız, Gökmen; Mıstık, Reşit; Bursa Uludağ Üniversitesi/Tıp Fakültesi/Enfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Anabilim Dalı.; DFY-3761-2022; 6602564624
Background/Aims: mbitasvir/paritaprevir/ritonavir (OMV/PTV/r) +/- dasabuvir (DSV) +/- ribavirin (RBV) combination has demonstrated excellent rates of sustained virologic response (SVR) and a very good safety profile in patients with the chronic hepatitis C virus (HCV) genotype 1 or 4 infections. We aimed to investigate the effectiveness and safety of OMV/PTV/r +/- DSV +/- RBV combination regimen in a real-world clinical practice.Materials and Methods: Data from HCV genotype 1 and 4 patients treated with OMV/PTV/r +/- DSV +/- RBV (n=862) in 34 centers across Turkey between April 1, 2017 and August 31, 2018 were recorded in a large national database. Demographic, clinical, and virologic data were analyzed.Results: The mean age of the patients was 55.63, and 430 patients (49.9%) were male. The majority had HCV genotype 1b infection (77.3%), and 66.2% were treatment-naive. Non-cirrhosis was present at baseline in 789 patients (91.5%). SVR12 rate was 99.1% in all patients. Seven patients had virologic failure. No significant differences were observed in SVR12 according to HCV genotypes. HCV RNA was undetectable at treatment week 4 in 90.9%, at treatment week 8 in 98.5%, and at the end of treatment (EOT) in 98.9%. SVR12 ratio was significantly higher in the non-cirrhotic patients compared to that in the compensated cirrhotic patients. Rates of adverse events (AEs) in the patients was 59.7%.Conclusion: The present real-life data of Turkey for the OBV/PTV/r +/- DSV +/- RBV treatment of patients with HCV genotype 1b, 1a, or 4 infection from 862 patients demonstrated high efficacy and a safety profile.