Safety, effectiveness and t-cell activation profiles of long-term myrcludex-B treatment in two patients with hdv related compensated cirrhosis

Abstract

Mycludex B (MYR) is a new promising anti-HDV therapy, but the effectiveness and safety of long-term administration in compensated cirrhotics treated in a real-life setting are presently unknown. Aim of this study was therefore to describe the effectiveness, safety and impact on HDV/HBV-specific T cell profiles in the first two European patients treated with MYR outside clinical trials. Methods. A 69-year-old female and 51-year-old male Caucasian HBeAg-negative patients with HDV related compensated cirrhosis on long-term term TDF treatment, started MYR 10 mg/day on January and May 2018 in a compassionate use program. Liver function tests, bile acids and virological markers were monitored every 4 weeks. HDV RNA was tested by RoboGene®.