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Case Report| Volume 78, ISSUE 4, P876-880, April 2023

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A 3-year course of bulevirtide monotherapy may cure HDV infection in patients with cirrhosis

      Summary

      Bulevirtide recently received conditional approval from the EMA for the treatment of chronic hepatitis delta, but the ideal duration of therapy is unknown. Herein, we describe the first case of hepatitis delta cure following 3 years of bulevirtide monotherapy in a patient with compensated cirrhosis and esophageal varices. During the 72-week off-bulevirtide follow-up, virological and biochemical responses were maintained. In the off-therapy liver biopsy, intrahepatic HDV RNA and hepatitis D antigen were undetectable, <1% of hepatocytes were hepatitis B surface antigen positive and all were negative for hepatitis B core antigen. Ishak grading and staging were improved following treatment.

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      References

        • Cornberg M.
        • Lok A.S.
        • Terrault N.A.
        • Zoulim F.
        2019 EASL-AASLD HBV treatment endpoints conference faculty. Guidance for design and endpoints of clinical trials in chronic hepatitis B - report from the 2019 EASL-AASLD HBV treatment endpoints conference.
        J Hepatol. 2020; 72: 539-557
        • Urban S.
        • Neumann-Haefelin C.
        • Lampertico P.
        Hepatitis D virus in 2021: virology, immunology and new treatment approaches for a difficult-to-treat disease.
        Gut. 2021; 70: 1782-1794
        • Wedemeyer H.
        • Bogomolov P.
        • Blank A.
        • Allweiss L.
        • Dandri-Petersen M.
        • Bremer B.
        • et al.
        Final results of a multicenter, open-label phase 2b clinical trial to assess safety and efficacy of myrcludex B in combination with tenofovir in patients with chronic HBV/HDV co-infection.
        J Hepatol. 2018; 68: S3
        • Wedemeyer H.
        • Aleman S.
        • Brunetto M.
        • Blank A.
        • Andreone P.
        • Bogolomov P.
        • et al.
        Efficacy and safety of bulevirtide monotherapy given at 2 mg or 10 mg dose level once daily for treatment of chronic hepatitis delta: week 48 primary end point results from a phase 3 randomized, multicenter, parallel design study.
        J Hepatol. 2022; 77: S4
        • Fontaine H.
        • Fougerou-Leurent C.
        • Gordien E.
        • Scholtes C.
        • Metivier S.
        • De Lédinghen V.
        • et al.
        Real life study of bulevirtide in chronic hepatitis delta: preliminary results of the ANRS HD EP01 BuleDelta prospective cohort.
        J Hepatol. 2022; 77: S72
        • Dietz C.
        • Tacke F.
        • Zöllner C.
        • Demir M.
        • Schmidt M.
        • Schramm C.
        • et al.
        Bulevirtide treatment of hepatitis D in Germany: multicentre real-world experience.
        J Hepatol. 2022; 77: S823
        • Degasperi E.
        • Anolli M.P.
        • Uceda Renteira S.C.
        • Sambarino D.
        • Borghi M.
        • Perbellini R.
        • et al.
        Bulevirtide monotherapy for 48 weeks in HDV patients with compensated cirrhosis and clinically significant portal hypertension.
        J Hepatol. 2022; 77: 1525-1531
        • Loglio A.
        • Ferenci P.
        • Uceda Renteria S.C.
        • Tham C.Y.L.
        • Scholtes C.
        • Holzmann H.
        • et al.
        Safety and effectiveness of up to 3 years' bulevirtide monotherapy in patients with HDV-related cirrhosis.
        J Hepatol. 2022; 76: 464-469
        • Obermayer-Straub P.
        • Manns M.P.
        Hepatitis C and D, retroviruses and autoimmune manifestations.
        J Autoimmun. 2001; 16: 275-285
        • Kefalakes H.
        • Horgan X.J.
        • Jung M.K.
        • Amanakis G.
        • Kapuria D.
        • Bolte F.J.
        • et al.
        Liver-resident bystander CD8+ T cells contribute to liver disease pathogenesis in chronic hepatitis D virus infection.
        Gastroenterology. 2021; 161: 1567-1583.e9
        • Heidrich B.
        • Yurdaydın C.
        • Kabaçam G.
        • Ratsch B.A.
        • Zachou K.
        • Bremer B.
        • et al.
        Late HDV RNA relapse after peginterferon alpha-based therapy of chronic hepatitis delta.
        Hepatology. 2014; 60: 87-97