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Early virological response in six patients with hepatitis D virus infection and compensated cirrhosis treated with Bulevirtide in real‐life
Author(s) -
Asselah Tarik,
Loureiro Dimitri,
Le Gal Fréderic,
Narguet Stéphanie,
Brichler Ségolène,
Bouton Valérie,
Abazid Malek,
Boyer Nathalie,
Giuly Nathalie,
Gerber Athenais,
Tout Issam,
Maylin Sarah,
Bed Cheikh M.,
Marcellin Patrick,
Castelnau Corinne,
Gordien Emmanuel,
Mansouri Abdellah
Publication year - 2021
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.14950
Subject(s) - medicine , hbsag , hepatitis d virus , gastroenterology , hepatitis d , cirrhosis , viral load , liver disease , virus , hepatitis b virus , immunology
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 10 and 3/3 of 2 log 10 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 10 at 8 weeks and 1/1 by 2 log 10 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]).