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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) Demirtürk, Neşe; Aygen, Bilgehan; Çelik, İlhami; Mistik, Reşit; Akhan, Sıla; Barut, Şener; Ural, Onur; Batırel, Ayşe; Şimsek, Funda; Ersöz, Gülden; İnan, Dilara; Kınıklı, Sami; Türker, Nesrin; Bilgin, Hüseyin; Gürbüz, Yunus; Tülek, Necla; Tarakçı, Hüseyin; Yıldız, Orhan; Türkoğlu, Emine; Güzel, Deniz Kamalak; Şimsek, Sümeyra; Tuna, Nazan; Demir, Nazlım Aktuğ; Çağatay, Atahan; Çetinkaya, Rıza Aytaç; Karakeçili, Faruk; Hakyemez, İsmail Necati; Ertem, Günay Tuncer; Örmen, Bahar; Korkmaz, Pınar; Sili, Uluhan; Kuruüzüm, Ziya; Şener, Alper; Özel, Selcan Arslan; Öztürk, Sinan; Süer, Kaya; Çelen, Mustafa Kemal; Konya, Petek; Asan, Ali; Saltoğlu, Neşe; Doğan, Nurhan
    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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    Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey
    (Galenos Publ House, 2015) Aygen, Bilgehan; Yildiz, Orhan; Akhan, Sila; Celen, Mustafa Kemal; Ural, Onur; Koruk, Suda Tekin; Kose, Sukran
    Background: The use of pegylated interferon alpha and ribavirin (PegIFN/RBV) for the retreatment of chronic hepatitis C virus (HCV) infection without a sustained virological response (SVR) prior to PegIFN/RBV treatment has resulted in low success rates. Aims: To investigate the efficacy and safety of telaprevir (TVR) in combination with PegIFN/RBV in patients infected with HCV genotypes 1 and 4 who were previously treated with PegIFN/RBV and failed to achieve SVR. Study Design: Multi-center, retrospective, cross-sectional study. Methods: The study included 111 patients: 80 prior relapsers, 25 prior null responders, and six prior partial responders to PegIFN/RBV treatment. The patients were given TVR/PegIFN/RBV for 12 weeks, followed by a 12-week PegIFN/RBV treatment; virological response results were assessed at weeks 4, 12, and 24. Treatment was discontinued in patients with HCV RNA >1000 IU/mL at week 4 or with negative RNA results at week 4 but >1000 IU/mL at week 12. Rapid virological response (RVR), early virological response (EVR), extended rapid virological response (eRVR), and virological response at 24th week of treatment were evaluated. The side effects of combination therapy and the rates of treatment discontinuation were investigated. Results: The mean age of the patients was 56.02 +/- 9.96 years and 45.9% were male. Ninety-one percent of the patients were infected with viral genotype 1, 69.6% with the interleukin (IL) 28B genotype CT and 20.2% were cirrhotic. The RVR rate was 86.3% in prior relapsers, 56% in prior null responders, and 50% in prior partial responders (p=0.002). EVR rates in those groups were 91.3%, 56%, and 83.3%, respectively (p<0.001). eRVR rates were 83.8% in prior relapsers, 48% in prior null responders, and 50% in prior partial responders (<0.001). The virological response at the 24th week of treatment was found to be the highest in prior relapsers (88.8%); it was 56% in prior null responders and 66.7% in prior partial responders (p<0.001). Common side effects were fatigue, headache, anorexia, malaise, anemia, pruritus, dry skin, rash, dyspepsia, nausea, pyrexia, stomachache, and anorectal discomfort. All treatments were discontinued due to side effects in 9.9% of patients. Conclusion: High virological response rates were obtained with TVR/PegIFN/RBV treatment. Although side effects were frequently observed, the discontinuation rate of combination therapy was low.