Background The length of treatment with triple therapy against hepatitis C virus genotype 1 (HCV-1), which comprises telaprevir, ribavirin and peginterferon α-2b, is variable, depending on the patient to be treated.
Purpose To evaluate the use and effectiveness of telaprevir in HCV-1 patients according to the SPC guidelines.
Materials and methods Retrospective observational study of HCV-1 mono-infected patients who started treatment with telaprevir, ribavirin and peginterferon α -2b. The follow-up period was 48 weeks. The variables analysed were: type of patient (treatment-naïve, relapsed, partial responder and non-responder), viral load (VL) at baseline, at 4, 12, 24, 36 and 48 weeks (IU/ml) and duration of treatment. For treatment-naïve and relapsed patients in which VL was undetectable at week 4 and 12, the treatment lasted 24 weeks, extending up to 48 weeks in patients with detectable VL. In the case of partial responders or non-responders, it is always 48 weeks. Furthermore, criteria for considering discontinuation were: VL >1000 (IU/ml) at weeks 4 or 12, and detectable VL at weeks 24 or 36, since it was unlikely that these patients would obtain a sustained viral response.
Results A total of 17 patients were included. Of the treatment-naïve and relapsed patients (14), the treatment of 2 of them did not follow the SPC. Although both had undetectable VL at 4 and 12 weeks the treatment continued for 48 weeks. Among partial responder and non-responder patients (3), 1 did not follow SPC recommendations; treatment was suspended after 24 weeks, but VL was detectable again at week 48. Premature suspension in this case was not due to toxicity reasons. Viral load remained undetectable at week 48 in 14 of the remaining patients.
Conclusions The treatment in our study did not follow SPC recommendations in 18% (3/17) of patients. Triple therapy was not effective in 1 of 3 patients who stopped at week 24 (shorter than recommended). We advise establishing a cutoff point at week 24, and evaluating the patient type (treatment-naïve/relapsed or partial responder/non-responder) before deciding to suspend treatment early, as well as determining VL at weeks 4 and 12 for correct adjustment of treatment duration.
No conflict of interest.
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