Treatment efficacy of Telaprevir and Boceprevir based triple therapy in Genotype 1 Hepatitic C infection-an Australian dual centre experience.

Abstract

Introduction: The introduction of direct-acting antivirals (DAAs) has resulted in increasing numbers of patients with genotype 1 HCV receiving triple therapy. The majority of data relating to treatment experience has originated from Europe or North America, with a paucity of data from Australia.We aimed to evaluate the treatment efficacy of Telaprevir (TVR) and Boceprevir (BOC) based triple therapy in a uniquely Australian population, more reflective of real-world clinical practice. Method(s): A retrospective observational analysis was conducted in two large tertiary referral centres. Patients receiving Telaprevir (TVR) or Boceprevir (BOC) combined with peginterferon-alpha-2a/2b and ribavirin (PR) were identified via electronic hospital databases. Demographic, clinical and virological data were then collected through medical and pathology records. Advanced liver fibrosis was characterised by histology (METAVIR 3-4) and/or transient elastography (>9.5 kPa). Virological response (VR) was defined as undetectable HCV RNA using a sensitive quantitative PCR assay. Result(s): In this interim analysis, a total of 153 patients (BOCN = 80,TVR N = 73) at different stages of treatment were included. The majority were male (63%) and Caucasian (65%), with mean age of 51 years. Advanced fibrosis was present in 51% and 27% had prior PR treatment. The IL28B genotype distribution was 38% CC, 50% CT and 12% TT. HCV Genotype distribution comprised 68% 1a, 27% 1b and 5% 6C-1. 50% were eligible for response guided therapy. 54% of the BOC group and 37% of the TVR group had completed the prescribed treatment course at the time of submission. Baseline characteristics were comparable between both groups. Table 1 presents an interim analysis of virological responses and early discontinuation rates for each drug. Virological responses were consistently lower in cirrhotic patients at all time-points for both drugs. 37/153 (24%) stopped treatment early, 14% due to treatment futility and 10% due to adverse events. Early discontinuation rates were higher in cirrhotic patients. There was one death related to infection. Further analysis of treatment-related morbidity is presented separately. Conclusion(s): This study is the first real-world study of clinical experience with TVR and BOC in Australia. The patient cohort was notable for a high ratio of "hard-to-cure" characteristics, including advanced liver fibrosis. Despite this, interim virological response rates were acceptable. (Table Presented).