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.
Bulevirtide for patients with chronic Hepatitis D (CHD) in Italy: a multicenter prospective nationwide real-life study (D-Shield) / Anolli 1, M. P.; Degasperi 1, E.; D’Offizi 2, G.; Rianda 2, A.; Loglio 3, A.; Viganò 3, M. O.; Ciancio 4, A.; Troshina 4, Y.; Brunetto 5, M. R.; Coco 5, B.; Zaltron 6, S.; Turco 7, L.; Sarmati 8, L.; Milella 9, M.; Toniutto 10, P.; Marinaro 11, L.; Russo 12, F. P.; Gori 13, A.; Maida, I.; Federico 15, A.; Santantonio 16, T. A.; Giannini 17, E. G.; Verucchi 18, G.; Morisco 19, F.; Mangia 20, A.; De Nicola 21, S.; Pinchera 22, B.; Maracci 23, M.; Romano 24, A.; Crocè 25, S. L.; Gatti 26, P.; †, ; Zampino 27, R.; Persico 28, M.; Pozzoni 29, P.; Pan 30, A.; Pellicelli 31, A.; Coppola 32, N.; Pileri 33, F.; Tonnini 34, M.; Soria 35, A.; Puoti 36, M.; Lampertico, P.. - In: DIGESTIVE AND LIVER DISEASE. - ISSN 1878-3562. - 57:1(2025). [10.1016/j.dld.2025.01.030]
Bulevirtide for patients with chronic Hepatitis D (CHD) in Italy: a multicenter prospective nationwide real-life study (D-Shield)
I. Maida
;
2025-01-01
Abstract
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
