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Journal Article Ppublish 37 citations

PubMed: 33999515 DOI: 10.1111/liv.14950

Early virological response in six patients with hepatitis D virus infection and compensated cirrhosis treated with Bulevirtide in real-life.

Liver Int 41(7):1509-1517

Authors: Tarik Asselah, Dimitri Loureiro, Fréderic Le Gal, Stéphanie Narguet, Ségolène Brichler, Valérie Bouton, Malek Abazid, Nathalie Boyer, Nathalie Giuly, Athenais Gerber, Issam Tout, Sarah Maylin, Cheikh M Bed, Patrick Marcellin, Corinne Castelnau, Emmanuel Gordien, Abdellah Mansouri

Affiliations

  • Centre de recherche sur l'inflammation, Université́ de Paris, Inserm U1149, CNRS ERL8252, Paris, France.
  • Department of Hepatology, AP-HP, Hôpital Beaujon, Clichy, France.
  • Laboratoire de Microbiologie Clinique, Centre National de référence des Hépatites B, C et Delta, Université de Paris 13, Inserm U955, AP-HP, Hôpital Avicenne, Bobigny, France.
  • Centre de recherche sur l'inflammation, Université́ de Paris, Inserm U1149, CNRS ERL8252, Paris, France. Department of Hepatology, AP-HP, Hôpital Beaujon, Clichy, France.
  • Service de Pharmacie, Université́ de Paris, AP-HP, Hôpital Beaujon, Clichy, France.
  • Laboratoire de Microbiologie, Université de Paris, AP-HP, Hôpital Saint-Louis, Paris, France.

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 log and 3/3 of 2 log 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 log at 8 weeks and 1/1 by 2 log 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]).

MeSH

Liver Diseases, Hepatitis B Surface Antigens, Drug Development, Hepatitis D, Hepatitis Delta Virus, Liver, Viruses, Therapeutics, Infections, Hepatitis, Virus Diseases

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