Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver · 2026
Effectiveness and safety of three years of bulevirtide monotherapy in patients with HDV-related compensated cirrhosis: the Italian compassionate use program.
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Anolli Maria Paola, Degasperi Elisabetta, D'Offizi Gianpiero, De Maria Francesco, Rianda Alessia, Brunetto Maurizia R, Coco Barbara, Verucchi Gabriella, Ciancio Alessia, Mangia Alessandra, Santantonio Teresa A, Coppola Nicola, Pellicelli Adriano, Viganò Mauro, Loglio Alessandro, Federico Alessandro, Pileri Francesca, Maracci Monia, Tonnini Matteo, Puoti Massimo, Lampertico Pietro, HEP4Di study group
Аннотация
BACKGROUND: Bulevirtide (BLV) monotherapy for up to 144 weeks was safe and effective in patients with chronic hepatitis D (CHD) in a phase III trial, but long-term real-world data are limited. We evaluated its effectiveness and safety in patients with HDV-related cirrhosis in clinical practice.
METHODS: Consecutive patients with HDV-related cirrhosis treated with BLV 2 mg/day monotherapy through the Italian compassionate use program were included. Virological (VR), biochemical (BR), and combined responses (CR), undetectable HDV RNA, virological and biochemical breakthroughs (VBK and BBK), non-invasive tests (NITs), safety, and liver-related events were assessed.
RESULTS: Ninety-seven patients were enrolled: median age, 52 years (interquartile range, 40-61); 53% were male; 96% were European; and 92% had Child-Pugh class A cirrhosis. VR, BR, CR, and HDV RNA target-not-detected/below-the-limit-of-detection rates increased over time, with 144-week cumulative incidences of 77%, 84%, 64%, and 53%, respectively. Overall, 11% and 5% of patients experienced a VBK and BBK, respectively. LSM, APRI, FIB-4, and LSPS, but not SSM, declined significantly during therapy. The 3-year cumulative probabilities of decompensation and HCC were 1.3% (95% CI, 1-3%) and 10% (95% CI, 4-19%), respectively. Treatment was well tolerated.
CONCLUSION: Long-term BLV 2 mg/day monotherapy was safe and effective in patients with cirrhosis. Response rates increased over time, while decompensating events remained uncommon.
METHODS: Consecutive patients with HDV-related cirrhosis treated with BLV 2 mg/day monotherapy through the Italian compassionate use program were included. Virological (VR), biochemical (BR), and combined responses (CR), undetectable HDV RNA, virological and biochemical breakthroughs (VBK and BBK), non-invasive tests (NITs), safety, and liver-related events were assessed.
RESULTS: Ninety-seven patients were enrolled: median age, 52 years (interquartile range, 40-61); 53% were male; 96% were European; and 92% had Child-Pugh class A cirrhosis. VR, BR, CR, and HDV RNA target-not-detected/below-the-limit-of-detection rates increased over time, with 144-week cumulative incidences of 77%, 84%, 64%, and 53%, respectively. Overall, 11% and 5% of patients experienced a VBK and BBK, respectively. LSM, APRI, FIB-4, and LSPS, but not SSM, declined significantly during therapy. The 3-year cumulative probabilities of decompensation and HCC were 1.3% (95% CI, 1-3%) and 10% (95% CI, 4-19%), respectively. Treatment was well tolerated.
CONCLUSION: Long-term BLV 2 mg/day monotherapy was safe and effective in patients with cirrhosis. Response rates increased over time, while decompensating events remained uncommon.