title: Evaluation of Dual Therapy in Real Life Setting in Treatment-Naïve Turkish Patients with HCV Infection: A Multicenter, Retrospective Study.
abstract: BACKGROUND
  Before the introduction of direct-acting antivirals in the treatment of chronic hepatitis C patients, the combination of peginterferon alpha and ribavirin was the standard therapy. Observational studies that investigated sustained virological response (SVR) rates by these drugs yielded different outcomes.
  
  
  OBJECTIVE
  The goal of the study was to demonstrate real life data concerning SVR rate achieved by peginterferon alpha plus ribavirin in patients who were treatment-naïve.
  
  
  METHODS
  A multicenter, retrospective observational study.
  
  
  METHODS
  The study was conducted retrospectively on 1214 treatment naïve-patients, being treated with peginterferon alpha-2a or 2b plus ribavirin in respect of the current guidelines between 2005 and 2013. The patients' data were collected from 22 centers via a standard form, which has been prepared for this study. The data included demographic and clinical characteristics (gender, age, body weight, initial Hepatitis C virus RNA (HCV RNA) level, disease staging) as well as course of treatment (duration of treatment, outcomes, discontinuations and adverse events). Renal insufficiency, decompensated liver disease, history of transplantation, immunosuppressive therapy or autoimmune liver disease were exclusion criteria for the study. Treatment efficacy was assessed according to the patient's demographic characteristics, baseline viral load, genotype, and fibrosis scores.
  
  
  RESULTS
  The mean age of the patients was 50.74 (±0.64) years. Most of them were infected with genotype 1 (91.8%). SVR was achieved in 761 (62.7%) patients. SVR rate was 59.1% in genotype 1, 89.4% in genotype 2, 93.8% in genotype 3, and 33.3% in genotype 4 patients. Patients with lower viral load yielded higher SVR (65.8% vs. 58.4%, p=0.09). SVR rates according to histologic severity were found to be 69.3%, 66.3%, 59.9%, 47.3%, and 45.5% in patients with fibrosis stage 0, 1, 2, 3 and 4, respectively. The predictors of SVR were male gender, genotype 2/3, age less than 45 years, low fibrosis stage, low baseline viral load and presence of early virological response. SVR rates to each peginterferon were found to be similar in genotype 1/4 although SVR rates were found to be higher for peginterferon alpha-2b in patients with genotype 2/3. The number of patients who failed to complete treatment due to adverse effects was 33 (2.7%). The number of patients failed to complete treatment due to adverse effects was 33 (2.7%).
  
  
  CONCLUSIONS
  Our findings showed that the rate of SVR to dual therapy was higher in treatment-naïve Turkish patients than that reported in randomized controlled trials. Also peginterferon alpha-2a and alpha-2b were found to be similar in terms of SVR in genotype 1 patients.
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.
authors.forename: Yunus
authors.initials: Y
authors.lastname: Gürbüz
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Ankara Training and Research Hospital, Ankara, Turkey.
authors.forename: Necla Eren
authors.initials: NE
authors.lastname: Tülek
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.
authors.forename: Emin Ediz
authors.initials: EE
authors.lastname: Tütüncü
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Harran University Faculty of Medicine, Şanlıurfa, Turkey.
authors.forename: Süda Tekin
authors.initials: ST
authors.lastname: Koruk
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Erciyes University Faculty of Medicine, Kayseri, Turkey.
authors.forename: Bilgehan
authors.initials: B
authors.lastname: Aygen
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Afyon Kocatepe University Faculty of Medicine, Afyonkarahisar, Turkey.
authors.forename: Neşe
authors.initials: N
authors.lastname: Demirtürk
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Ankara Training and Research Hospital, Ankara, Turkey.
authors.forename: Sami
authors.initials: S
authors.lastname: Kınıklı
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Mersin University Faculty of Medicine, Mersin, Turkey.
authors.forename: Ali
authors.initials: A
authors.lastname: Kaya
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Okmeydanı Training and Research Hospital, İstanbul, Turkey.
authors.forename: Taner
authors.initials: T
authors.lastname: Yıldırmak
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Near East University Faculty of Medicine, Nicosia, North Cyprus.
authors.forename: Kaya
authors.initials: K
authors.lastname: Süer
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Konya Training and Research Hospital, Konya, Turkey.
authors.forename: Fatime
authors.initials: F
authors.lastname: Korkmaz
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Selçuk University Faculty of Medicine, Konya, Turkey.
authors.forename: Onur
authors.initials: O
authors.lastname: Ural
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Kocaeli University Faculty of Medicine, Kocaeli, Turkey.
authors.forename: Sıla
authors.initials: S
authors.lastname: Akhan
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Gaziosmanpaşa University Faculty of Medicine, Tokat, Turkey.
authors.forename: Özgür
authors.initials: Ö
authors.lastname: Günal
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Sakarya University Faculty of Medicine, Sakarya, Turkey.
authors.forename: Nazan
authors.initials: N
authors.lastname: Tuna
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Tepecik Training and Research Hospital, İzmir, Turkey.
authors.forename: Şükran
authors.initials: Ş
authors.lastname: Köse
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Süleyman Demirel University Faculty of Medicine, Isparta, Turkey.
authors.forename: İbak
authors.initials: İ
authors.lastname: Gönen
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, İzmir Katip Çelebi University Atatürk Training and Research Hospital, İzmir, Turkey.
authors.forename: Bahar
authors.initials: B
authors.lastname: Örmen
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, İzmir Katip Çelebi University Atatürk Training and Research Hospital, İzmir, Turkey.
authors.forename: Nesrin
authors.initials: N
authors.lastname: Türker
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, İstanbul University Cerrahpaşa Faculty of Medicine, İstanbul, Turkey.
authors.forename: Neşe
authors.initials: N
authors.lastname: Saltoğlu
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Kartal Dr. Lütfi Kırdar Training and Research Hospital, İstanbul, Turkey.
authors.forename: Ayşe
authors.initials: A
authors.lastname: Batırel
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Ankara Training and Research Hospital, Ankara, Turkey.
authors.forename: Günay
authors.initials: G
authors.lastname: Tuncer
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Ankara Training and Research Hospital, Ankara, Turkey.
authors.forename: Cemal
authors.initials: C
authors.lastname: Bulut
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Abant İzzet Baysal University Faculty of Medicine, Bolu, Turkey.
authors.forename: Fatma
authors.initials: F
authors.lastname: Sırmatel
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, GATA Haydarpaşa Training and Research Hospital, İstanbul, Turkey.
authors.forename: Asım
authors.initials: A
authors.lastname: Ulçay
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, GATA Haydarpaşa Training and Research Hospital, İstanbul, Turkey.
authors.forename: Ergenekon
authors.initials: E
authors.lastname: Karagöz
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Ulus State Hospital, Ankara, Turkey.
authors.forename: Derviş
authors.initials: D
authors.lastname: Tosun
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Çanakkale Onsekiz Mart University Faculty of Medicine, Çanakkale, Turkey.
authors.forename: Alper
authors.initials: A
authors.lastname: Şener
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Kocaeli University Faculty of Medicine, Kocaeli, Turkey.
authors.forename: Aynur
authors.initials: A
authors.lastname: Aynıoğlu
authors.affiliation: Department of Infectious Diseases and Clinical Microbiology, Kocaeli University Faculty of Medicine, Kocaeli, Turkey.
authors.forename: Elif Sargın
authors.initials: ES
authors.lastname: Altunok
keywords: Hepatitis C; peginterferon alpha-2a; peginterferon alpha-2b; ribavirin; therapy