CP-105 Effectiveness and safety of protease inhibitors telaprevir and boceprevir in the treatment of hepatitis C virus infections in clinical practice

Background The efficacy of triple therapy (pegylated-interferon/ribavirin with boceprevir (BOC) or telaprevir (TVR) in phase III trials is known but not the effectiveness of HCV treatment in clinical practice. Purpose To investigate the effectiveness and safety of triple therapy with protease inhibitors TVR or BOC in the treatment of patients with Hepatitis C Virus (HCV) in clinical practice. Material and methods A retrospective observational study with HCV-infected patients treated with TVR or BOC who had completed 60 weeks from the start of treatment in six public hospitals serving 1,100,000 inhabitants. Patients who started treatment between January 2012 and March 2013 were included. We assessed the percentage of patients with a 12-week sustained viral response (SVR12) and the percentage of treatments discontinued due to adverse effects. Results 160 patients were treated; 9 patients were excluded as SVR12 had not been recorded, leaving 151 patients for analysis. Characteristics: male 66%, age 51 years (range 28–70); 98% genotype-1; 73% HCV-RNA > 800,000 IU/ml; Previous treatment: 48% treatment-naive, 25% relapsers, 13% partial responders, 11% null responders, 1% post-transplant reinfection and 1% unknown. Fibrosis stage: 55% F4, 33% F3, 9% F2, 2% F1, 1% unknown. 87% with TVR and 13% with BOC. Of the patients, 57% achieved SVR12 (60% naive, 68% relapsers, 40% partial responders, 37% null-responders or unknown, 100% post-transplant reinfection). According to fibrosis stage the response was 0% F1, 28% F2, 62% F3, 61% F4. Treatment was discontinued in 17 patients (11.3%) due to severe adverse effects. Conclusion Although the treated population presented an advanced stage of fibrosis (88% F3–F4), 57% achieved SVR12, lower than the pivotal TVR study. Compared to the International Telaprevir Access Program (similar to this cohort), we achieve a lower response in almost all types of patients, especially in partial responders (15% lower response rate). The side effect profile was slightly lower than other published series. References and/or Acknowledgements None No conflict of interest.