Bulevirtide for patients with chronic Hepatitis D (CHD) in Italy: a multicenter prospective nationwide real-life study (D-Shield)

IF 4 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Digestive and Liver Disease Pub Date : 2025-02-01 DOI:10.1016/j.dld.2025.01.030

M.P. Anolli , E. Degasperi , G. D'Offizi , A. Rianda , A. Loglio , M.O. Viganò , A. Ciancio , Y. Troshina , M.R. Brunetto , B. Coco , S. Zaltron , L. Turco , L. Sarmati , M. Milella , P. Toniutto , L. Marinaro , F.P. Russo , A. Gori , I. Maida , A. Federico , P. Lampertico

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Abstract

Background

Bulevirtide (BLV) has been available in Italy since May 2023 for patients with chronic hepatitis Delta (CHD), but no studies have addressed features of patients treated with BLV and their responses to treatment yet.

Methods

CHD patients starting BLV 2 mg/day as monotherapy or in combination with pegIFNα were included in a multicenter prospective real-life Italian study (D-SHIELD). Patients’ characteristics and treatment responses were assessed at baseline and trimonthly afterwards.

Results

369 patients from 36 centers were enrolled in this ongoing study. 99% received BLV 2 mg/day monotherapy: age 54 (28-82) years, 55% men, 76% cirrhotics, 96% on NUC therapy. Among cirrhotics, 39% had varices, 10% history of HCC, 10% of ascites, 3% of varices hemorrhage, 7% were decompensated. As of November 2024, 170 patients have completed 48 weeks of treatment. ALT declined: from 75 (16-1,074) U/I at baseline to 34 (7-198), 34 (7-236), and 32 (11-216) U/L at week 24, 32 and 48, respectively (p<0,0001). HDV RNA declined from 5.3 (1.5-8.2) at baseline to 3.4 (0.3-7.3), 2.8 (0.2-7.2), and 2.5 (0.3-7.3) at week 24, 32 and 48, respectively (p<0,0001). Virological, biochemical and combined responses were achieved by 42%, 65% and 31% of patients at week 24; 61%, 67% and 43% of patients at week 32, and by 64% 70% and 47% of patients at week 48. Among non-virological responders, 61%, 46% and 47% achieved a partial virological response (HDV RNA decline >1 but <2 Log IU/mL, compared to baseline) at week 24, 32, and 48. Moreover, 11%, 21% and 22% of patients achieved HDV RNA undetectable at week 24, 32 and 48, respectively.

Conclusions

D-SHIELD is the largest single country study on BLV treatment for CHD in Europe. Almost all patients started BLV as monotherapy. Virological, biochemical and combined responses at week 48 compared with previous retrospective studies.

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来源期刊

Digestive and Liver Disease 医学-胃肠肝病学

CiteScore

6.10

自引率

2.20%

发文量

632

审稿时长

19 days

期刊介绍： Digestive and Liver Disease is an international journal of Gastroenterology and Hepatology. It is the official journal of Italian Association for the Study of the Liver (AISF); Italian Association for the Study of the Pancreas (AISP); Italian Association for Digestive Endoscopy (SIED); Italian Association for Hospital Gastroenterologists and Digestive Endoscopists (AIGO); Italian Society of Gastroenterology (SIGE); Italian Society of Pediatric Gastroenterology and Hepatology (SIGENP) and Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD). Digestive and Liver Disease publishes papers on basic and clinical research in the field of gastroenterology and hepatology. Contributions consist of: Original Papers Correspondence to the Editor Editorials, Reviews and Special Articles Progress Reports Image of the Month Congress Proceedings Symposia and Mini-symposia.