Background The protease inhibitors (PI) boceprevir and telaprevir are associated with new adverse events (AEs) which can reduce quality of life.
Purpose To evaluate the safety of triple therapy with PI in monoinfected patients with genotype 1 hepatitis C virus (HCV).
Materials and methods A prospective observational study of patients with triple therapy for chronic HCV infection from November 2012 to April 2013. We recorded the following clinical variables: age, sex and baseline laboratory values (haemoglobin (Hb), platelets, neutrophils) and the management of the AEs at each visit to the pharmaceutical care consultation.
Results We included 16 patients, 15 men (93.7%) with a mean age of 55 years. The PI used: 8 patients with telaprevir and 8 with boceprevir. The mean laboratory values before treatment were: Hb = 15.2 g/dl, platelets = 149 × 103/mm3, neutrophils/mm3 = 2766. Only 5 patients started treatment with abnormal laboratory values: 3 with thrombocytopenia, 2 with neutropenia and one of these also with anaemia. Three patients were excluded from the analysis of AEs. AEs reported: anaemia: 46.2% (6/13) grade 1, 15.4% (2/13) grade 2, 15.4% (2/13) grade 3 and 7.6% (1/13) grade 4. Management strategies included: ribavirin dose reduction 38.5% (5/13), blood transfusions 15.4% (2/13) and erythropoietin administration 23.1% (3/13). Regarding thrombocytopenia: 30.7% (4/13) grade 1, 38.5% (5/13) grade 2 and 7.6% (1/13) both grade 3 and grade 4. The dose of peginterferon was reduced in 1 patient due to AEs and another due to weight adjustment. Taste disorders increases from week 4, reaching to 38% (5/13). Anorectal disorders were reported with both PI (23%; 3/13 patients) in the first 4 weeks, decreasing afterwards. The itchy rash reached its peak incidence (53%) from week 8.
Conclusions No patients had to discontinue triple therapy due to the reported adverse events. Anaemia and thrombocytopenia were the AEs with the highest incidence and clinical importance in treatment.
No conflict of interest.
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