Yunus Gürbüz 1, Emin Ediz Tütüncü 1, Necla Eren Tülek 2, Sami Kınıklı 2, Günay Tuncer 2, Cemal Bulut 2, Süda Tekin Koruk 3, Bilgehan Aygen 4, Neşe Demirtürk 5, Ali Kaya 6, Taner Yıldırmak 7, Kaya Süer 8, Fatime Korkmaz 9, Onur Ural 10, Sıla Akhan 11, Aynur Aynıoğlu 11, Elif Sargın Altunok 11, Özgür Günal 12, Nazan Tuna 13, Şükran Köse 14, İbak Gönen 15, Bahar Örmen 16, Nesrin Türker 16, Neşe Saltoğlu 17, Ayşe Batırel 18, Fatma Sırmatel 19, Asım Ulçay 20, Ergenekon Karagöz 20, Derviş Tosun 21, Alper Şener 22
1Department of Infectious Diseases and Clinical Microbiology, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey
2Department of Infectious Diseases and Clinical Microbiology, Ankara Training and Research Hospital, Ankara, Turkey
3Department of Infectious Diseases and Clinical Microbiology, Harran University Faculty of Medicine, Şanlıurfa, Turkey
4Department of Infectious Diseases and Clinical Microbiology, Erciyes University Faculty of Medicine, Kayseri, Turkey
5Department of Infectious Diseases and Clinical Microbiology, Afyon Kocatepe University Faculty of Medicine, Afyonkarahisar, Turkey
6Department of Infectious Diseases and Clinical Microbiology, Mersin University Faculty of Medicine, Mersin, Turkey
7Department of Infectious Diseases and Clinical Microbiology, Okmeydanı Training and Research Hospital, İstanbul, Turkey
8Department of Infectious Diseases and Clinical Microbiology, Near East University Faculty of Medicine, Nicosia, North Cyprus
9Department of Infectious Diseases and Clinical Microbiology, Konya Training and Research Hospital, Konya, Turkey
10Department of Infectious Diseases and Clinical Microbiology, Selçuk University Faculty of Medicine, Konya, Turkey
11Department of Infectious Diseases and Clinical Microbiology, Kocaeli University Faculty of Medicine, Kocaeli, Turkey
12Department of Infectious Diseases and Clinical Microbiology, Gaziosmanpaşa University Faculty of Medicine, Tokat, Turkey
13Department of Infectious Diseases and Clinical Microbiology, Sakarya University Faculty of Medicine, Sakarya, Turkey
14Department of Infectious Diseases and Clinical Microbiology, Tepecik Training and Research Hospital, İzmir, Turkey
15Department of Infectious Diseases and Clinical Microbiology, Süleyman Demirel University Faculty of Medicine, Isparta, Turkey
16Department of Infectious Diseases and Clinical Microbiology, İzmir Katip Çelebi University Atatürk Training and Research Hospital, İzmir, Turkey
17Department of Infectious Diseases and Clinical Microbiology, İstanbul University Cerrahpaşa Faculty of Medicine, İstanbul, Turkey
18Department of Infectious Diseases and Clinical Microbiology, Kartal Dr. Lütfi Kırdar Training and Research Hospital, İstanbul, Turkey
19Department of Infectious Diseases and Clinical Microbiology, Abant İzzet Baysal University Faculty of Medicine, Bolu, Turkey
20Department of Infectious Diseases and Clinical Microbiology, GATA Haydarpaşa Training and Research Hospital, İstanbul, Turkey
21Department of Infectious Diseases and Clinical Microbiology, Ulus State Hospital, Ankara, Turkey
22Department of Infectious Diseases and Clinical Microbiology, Çanakkale Onsekiz Mart University Faculty of Medicine, Çanakkale, Turkey
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.
Aims: 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.
Study Design: 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%).
Conclusion: 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.
