Browsing by Author "Şimşek, Funda"

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    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.
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    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.