Effectiveness of ledipasvir/sofosbuvir in real-world patients with chronic hepatitis C: a collaborative treatment approach

Abstract

The effectiveness of ledipasvir/sofosbuvir (LDV/SOF) in routine use in clinical practice for the management of chronic hepatitis C virus (HCV) has not been well described. Data with prior agents suggest that management of HCV using an interprofessional approach in clinical practice is associated with better outcomes. This single-centre, prospective, observational cohort study evaluated patients treated with LDV/SOF for 8, 12 or 24 weeks as part of the standardized interprofessional treatment protocol at Novant Health Infectious Diseases Specialists. Eighty-four patients treated with LDV/SOF were evaluated; of these, 97.5% and 91.7% of patients achieved a sustained virological response (SVR) in the per-protocol analysis and the intention-to-treat analysis, respectively. Two patients were not cured after relapse of HCV. No patients required LDV/SOF discontinuation and all patients completed the appropriate treatment duration. The majority (56%) of patients reported no adverse effects and all adverse effects that were reported were mild. The most commonly reported adverse effects were headache and fatigue. SVR and tolerability rates were similar to those seen in the clinical trials. LDV/SOF was associated with a successful translation from the clinical trial setting to clinical practice. A collaborative treatment approach should be considered in the management of HCV.

Keywords: HCV; Hepatitis C virus; LDV/SOF; Ledipasvir/sofosbuvir; Real-life.