Background Interferon free oral therapies have become elective treatment for chronic hepatitis C virus (HCV) infection, especially in cirrhotic patients. High rates of sustained virological response (SVR) have been reported but real world data are required.
Purpose To describe virologic response to sofosbuvir (SOF) based interferon free oral therapy in clinical practice.
Material and methods Retrospective observational study of patients who initiated SOF based therapy between May 2014 and March 2015. Patients were treated with SOF-simeprevir (SMV)±ribavirin (RBV) for 12 weeks (12w) or SOF-daclatasvir (DCV)±RBV for 12 or 24 weeks (24w).
Demographic, pharmacological and microbiological data were collected. Primary endpoint: SVR at 12w post treatment (SVR12).
Analysis was performed using SPSS v19.
Results 100 patients were included (33 female, 19 HIV coinfected). Median age 56 years (range 35–72). 66% received SOF-SMV ± RBV 12w (44% with RBV) and 34% SOF-DCV ± RBV (79.5% for 24w. 17.6% with RBV). Prior therapy: 42 naïve/14 relapsers/44 non-responders to interferon based therapy. 86% had cirrhosis and 21% had previous liver transplantation. 80% were of genotype 1 (GT1) (GT1a/1b: 20/60). Median baseline HCV RNA level 534.854 IU/ml (Q1-Q3 111.533 to 2.2M UI/mL). By week 4, 36% of patients had undetectable HCV RNA. In 48.4% of patients who remained positive, HCV RNA was <30 IU/mL. Overall SVR12 rate: 85%. 93% of GT1 cirrhotic patients achieved SVR12 and no statistically significant differences were found in SVR12 in these patients based on HCV RNA at week 4 (<30 IU/mL vs >30 IU/mL: 96%/85%), GT1a versus GT1b (93%/92.3%), antiviral therapy (SOF-SMV: 91.7%; SOF-SMV+RBV: 94.7%; SOF-DCV: 89.5%; and SOF-DCV+RBV: 100%) or prior HCV treatment (naïve/treatment experienced: 93%/92%). When RBV was not used, 24w of treatment improved SVR12 in GT1 cirrhotic patients receiving SOF-DCV (12w/24w: 33.3%/100%, p = 0.018).
Conclusion The combinations SOF-SMV ± RBV and SOF-DCV ± RBV were highly effective in patients with GT1 and cirrhosis. No statistically significant differences were found according to HCV RNA level at week 4 or prior HCV treatment. Cirrhotic G1 patients receiving SOF-DCV without RBV benefited from 24w treatment duration but further studies are needed as the sample size was small.
No conflict of interest.
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