Background The new protease inhibitors (PIs) have proved effective in increasing the rate of Sustained Virological Response (SVR) in hepatitis C, 25%-30% better than standard treatment. However, triple therapy is associated with undesirable effects: skin rash (telaprevir), anaemia (telaprevir and boceprevir) and taste disorder (boceprevir).

Purpose To analyse effectiveness and safety with telaprevir and boceprevir in patients with hepatitis C, who met the inclusion criteria established by the Spanish Health Ministry and profile of these treatments.

Materials and methods The study period started after the inclusion of PIs in the pharmacotherapeutic guide. Patients who met the inclusion criteria were selected: Genotype 1, treatment-naïve or previously treated, F4 fibrosis stages in biopsy or FibroScan >9.5 Kilopascals, haemoglobin concentration >12 g/dl in women and >13 g/dl in men and compensated liver disease. Effectiveness was assessed based on SVR of triple therapy, at weeks 4 and 12 with telaprevir and at weeks 8 and 24 with boceprevir. SVR was defined as undetectable viral RNA in these weeks. Safety was assessed based on adverse events recorded in the clinical history or during the therapeutic drug monitoring.

Results A total of 20 patients (59% relapsers, 23% treatment-naïve, 12% non-responders and 6% partial responders) started treatment with PIs (16 telaprevir and 4 boceprevir). All patients met the inclusion criteria. Three patients were excluded due to not adequately following the protocol, withdrawal of medicines for adverse event (pancreatitis for telaprevir) and non recording of the viral load in the clinical history. Blood transfusion and rescue treatment with darbepoetin alfa was performed in 3 patients.

Conclusions

1. The rate of effectiveness achieved was higher than in clinical trials. However the main limitations of the study were the small sample size and the insufficient follow-up period.

2. Overall, the main adverse events were anaemia and taste disorders with telaprevir and boceprevir respectively. These results were similar to those of previous reports.

No conflict of interest.