Early virological response in six patients with hepatitis D virus infection and compensated cirrhosis treated with Bulevirtide in real-life
Abstract
Hepatitis delta virus (HDV) infection is the most severe form of viral hepatitis. Bulevirtide (BLV, Hepcludex®) is an HDV/HBV entry inhibitor approved in June 2020 in the European Union for adult patients with chronic hepatitis delta (CHD) and compensated liver disease and positive HDV RNA viral load. This real-life preliminary report described early virological efficacy and safety of BLV in six patients with CHD and compensated liver disease: four patients were treated with the combination of BLV (2 mg/d in subcutaneous injection) and pegylated interferon (PEG-IFN) and two patients with BLV monotherapy. Four patients treated with combined therapy had a decline of a minimum of 1 log10 and 3/3 of 2 log10 of HDV-VL at 12 and 24 weeks, respectively. One patient among four had stopped the treatment at 12 weeks because of thrombocytopenia and an HDV-VL relapse was notified 24 weeks after treatment cessation. Three patients among four (3/4) had undetectable HDV-VL during the therapy (<100 IU/ml). One patient (1/2) treated with BLV monotherapy had a decline of HDV-VL by 1 log10 at 8 weeks and 1/1 by 2 log10 at 28 week on-treatment. Two patients among four (2/4) with combined therapy had normal ALT reached at 4 and 56 weeks. One patient (1/2) with BLV monotherapy achieves ALT normalization at 4 weeks on treatment. Hepatitis B surface antigen (HBsAg) levels remain unchanged. Three among six (3/6) patients had an elevation of total biliary acids without pruritus. These early data generated confirm the interest in this new treatment. Final results will be important to demonstrate long-term clinical benefit (fibrosis reversibility and reduction in hepato-cellular carcinoma [HCC]).
CONFLICT OF INTEREST
Tarik Asselah has acted as a speaker and/or advisor board and/or investigator for Abbvie, Eiger Biopharmaceutical, Janssen, Gilead, Myr Pharmaceutical, Roche and Merck. Nathalie Boyer has acted as a speaker and investigator for Janssen, Gilead, Roche, Merck, Abbvie and Intercept. Corinne Castelnau has acted as a speaker and investigator Myr Pharmaceutical, Roche and Merck. Patrick Marcellin has acted as a speaker and investigator for Eiger Biopharmaceutical, Janssen, Gilead, Myr Pharmaceutical, Roche and Merck. Emmanuel Gordien has acted as a speaker and/or investigator for Eurobio and Gilead. Dimitri Loureiro, Fréderic Le Gal, Stéphanie Narguet, Segolène Brichler, Valérie Bouton, Malek Abazid, Athenais Gerber, Issam Tout, Sarah Maylin, Cheikh Mohamed Bed and Abdellah Mansouri declare no competing interests.
