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SUMMARY Background Data about adverse events are needed to optimise telaprevir-based therapy in a broad spectrum of patients. Aim To investigate adverse events of telaprevir-based therapy in patients with and without advanced fibrosis or cirrhosis in a real-world setting. Methods Data on 174 hepatitis C-infected patients initiating telaprevir-based therapy at Mount Sinai and Montefiore medical centres were collected. Biopsy data and FIB-4 scores identified patients with advanced fibrosis. Multivariable fully adjusted models were built to assess the effect of advanced fibrosis on specific adverse events and discontinuation of treatment due to an adverse event. Results Patients with (n = 71) and without (n = 103) advanced fibrosis were similar in BMI, ribavirin exposure, gender, prior treatment history, haemoglobin and creatinine, but differed in race. Overall, 47% of patients completed treatment and 40% of patients achieved SVR. Treated patients with and without advanced fibrosis or cirrhosis had similar rates of adverse events; advanced fibrosis, however, was independently associated with ano-rectal discomfort (P = 0.03). Three patients decompensated and had advanced fibrosis. The discontinuation of all treatment medications due to an adverse event was significantly associated with older age (P = 0.01), female gender (P = 0.01) and lower platelets (P = 0.03). Conclusions Adverse events were common, but were not significantly related to the presence of advanced fibrosis or cirrhosis. More critical monitoring in older and female patients with low platelets throughout treatment may reduce adverse event-related discontinuations.

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1, 2 and agree that the cost-effectiveness of this therapy is called into question by the number of patients who are unable to complete treatment and successfully achieve sustained virological response. We are analysing the cost-effectiveness of this regimen using real-world data.Ribavirin dose reduction during treatment was not recorded in more than 50% of our patients. As decisions on adverse event management were at the discretion of individual clinicians, anaemia management varied. Several patients received erythropoietin (EPO) therapy prior to ribavirin dose reduction, and some had signs of severe anaemia at the first or second visit and required blood transfusion before dose reduction might have been possible. Thus, great importance must be placed on careful patient monitoring when using these medications. With some exceptions, ribavirin dose was reduced when patients had haemoglobin levels of 10 g/dL or less. If haemoglobin levels fell to below 8.5 g/dL, patients were given EPO.As mentioned in our report, only 16% of our patients had IL28b testing; the results of this test were not used to reach a decision on initiation of therapy. We did not collect hepatitis C virus genotype-1 subtype data, but future studies will certainly examine the effect that genotype and subtype may have on the occurrence of adverse events. ACKNOWLEDGEMENTThe authors' declarations of personal and financial interests are unchanged from those in the original article.