DI-053 Multicenter study to determine the safety of protease inhibitors in patients infected with hepatitis C virus

Background Boceprevir (BOC) and telaprevir (TLV) have been approved recently for the treatment of chronic hepatitis C virus (HCV) infection but their safety remains to be studied. Purpose To analyse the incidence of adverse events (AEs) in patients treated with BOC and TLV according to their previous response to treatment with interferon and ribavirin. Materials and methods Retrospective, observational, multicentre study. Adverse events (AEs) and analytical data were collected from pharmacotherapeutic records of patients who started treatment with TLV or BOC between January 2012 and January 2013. Anaemia was defined as haemoglobin 3 /mm 3 and thrombocytopenia: platelet count 3 . The variables were: previous response to treatment: treatment-naive (N), non-responder (NR) or patient who had a relapse (R), age, sex, FibroScan, nadir haemoglobin, neutrophil count, platelet count, presence of rash and anorectal discomfort. The number of patients requiring erythropoietin (EPO) and filgrastim were recorded. Results 78 patients were investigated, the mean age was 50.9 years and 21 were women. Mean FibroScan value was 18.2 kPa. Patients: N = 19; (24.3%), NR = 29 (37.2%) and R = 30 (38.5%). The incidence of AEs were: a) hematologic: anaemia 47.4% (N), 55.5% (NR) and 60% (R); thrombocytopenia: 31.6% (N), 69% (NR) and 40% (R) and neutropenia: 5.3% (N), 34.5% (NR) and 20% (R). b) Dermatologic: pruritus 15.8% (N), 31% (NR) and 40% (R); rash: 31.6% (N), 17.2 (NR) and 10% (R) and anorectal discomfort: 0% (N), 17.2% (NR) and 40% (R). The percentage of patients requiring EPO: N = 26.3%, NR = 20.7% and 6.7% (R). Filgrastim was only used in four NR. Conclusions Haematological AEs: R patients showed a higher incidence of anaemia, conversely EPO was used in 26.3% of N patients indicating more severe anaemias. Neutropenia and thrombocytopenia were more frequent in NR. Dermatological AEs: Pruritus and anorectal discomfort were more common in R patients, nevertheless rash was more frequent in N patients. No conflict of interest.