Efficacy and safety profile of boceprevir- or telaprevir-based triple therapy or dual peginterferon alfa-2a or alfa-2b plus ribavirin therapy in chronic hepatitis C: the real-world PegBase observational study

Alessandra Mangia; Graham R. Foster; Christoph P. Berg; Manuela Curescu; Victor De Ledinghen; FranÃ§ois Habersetzer; Spilos Monolakopoulos; Elisa Negri; George Papatheodoridis; Silke Ahlers; Marco Castillo; Georgios Bakalos; Stefan Mauss

Authors Alessandra Mangia, Graham R. Foster, Christoph P. Berg, Manuela Curescu, Victor De Ledinghen, FranÃ§ois Habersetzer, Spilos Monolakopoulos, Elisa Negri, George Papatheodoridis, Silke Ahlers, Marco Castillo, Georgios Bakalos, Stefan Mauss.

Abstract

Background The aim of the study was to determine the efficacy and safety of triple therapy with a first-generation protease inhibitor (PI; boceprevir, telaprevir) plus peginterferon alfa-2a or -2b plus ribavirin, and dual therapy (peginterferon alfa-2a or -2b plus ribavirin) in patients with chronic hepatitis C (CHC) in routine clinical practice.

Methods PegBase was an international, prospective, observational study in which 4441 patients with CHC were enrolled in 27 countries. This analysis focuses on results in 4100 treatment-naÃ¯ve and previously treated patients treated with PI-based triple therapy or dual therapy, according to the discretion of the investigator and local standards of practice. The primary efficacy outcome was sustained virological response after 12-week follow up (SVR12).

Results SVR12 rates in treatment-naÃ¯ve genotype (G) 1 patients were 56.6% and 62.9% for recipients of boceprevir plus peginterferon alfa-2a/ribavirin and boceprevir plus peginterferon alfa-2b/ribavirin, respectively, and 65.3% and 58.6% for recipients of telaprevir plus peginterferon alfa-2a/ribavirin and telaprevir plus peginterferon alfa-2b/ribavirin, respectively. In previously treated patients assigned to these four regimens, SVR12 rates were 43.6%, 48.3%, 60.3% and 56.1%, respectively. Among treatment-naÃ¯ve patients assigned to peginterferon alfa-2a/ribavirin and peginterferon alfa-2b/ribavirin, respectively, SVR12 rates were 49.2% and 41.9% in G1 patients, 75.7% and 83.3% in G2 patients, 65.9% and 65.9% in G3 patients, and 49.7%, and 51.1% in G4 patients. The safety and tolerability of dual and triple therapy were consistent with previous reports.

Conclusion The efficacy and safety of first-generation PI-based triple-therapy and dual-therapy regimens in this real-world cohort were broadly comparable to those of previous studies.

Keywords Boceprevir, peginterferon, ribavirin, telaprevir, virological response

Ann Gastroenterol 2017; 30 (3): 327-343