Background The addition of telaprevir to peg-interferon and ribavirin represents a new treatment for hepatitis C (HCV) associated with an improvement in treatment response rates but an impairment of the safety profile.
Purpose To evaluate the safety of telaprevir-based treatment in patients with HCV infection in real clinical practise in a specialty hospital.
Materials and Methods Prospective and observational study of patients who started telaprevir between April and September 2012. Data were collected at each treatment visit at the hospital pharmacy through clinical interview and revision of analytical parameters.
Results We enrolled 14 patients treated with telaprevir, 9 mono-infected and 5 co-infected. All patients were between 18 and 70 years old, had HCV genotype-1 infection and had at least stage 3 liver fibrosis (Metavir score).Only two patients had received no previous treatment. In the pre-treated group, 42% of the patients had a previous relapse, 33% had a partial response, and 25% had no response.
43% of patients required ribavirin dose reduction due to anaemia (haemoglobin < 10 g/dl).
23% of patients needed erythropoietin-stimulating agents due to anaemia (haemoglobin < 8.5 g/dl even though the ribavirin dose had been reduced).
8% of patients required a blood transfusion
Telaprevir was stopped in one patient because of rash. No patients discontinued treatment because of anaemia.
Conclusions The safety profile of telaprevir was consistent with the findings in clinical trials. However, most of the adverse events were reported more frequently in patients in real clinical practise compared with previous results in clinical trials.
These serious and frequent adverse events may be an opportunity for pharmacists to get involved to improve the safety of this treatment.
No conflict of interest.
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