A Phase 3, Randomized Trial of Bulevirtide in Chronic Hepatitis D

This phase 3 trial evaluated the safety and efficacy of bulevirtide in patients with chronic hepatitis D virus (HDV) infection, with or without compensated cirrhosis. Patients were randomly assigned to receive 2 mg/day, 10 mg/day of subcutaneous bulevirtide, or delayed treatment (control group). At 48 weeks, combined virologic and biochemical responses (undetectable or ≥2 log₁₀ IU/mL reduction in HDV RNA and ALT normalization) occurred in 45% (2 mg), 48% (10 mg), and 2% (control). ALT normalization and HDV RNA decline were significantly improved in both dose groups compared to control, though HBsAg levels remained unaffected. Adverse events including pruritus, injection-site reactions, and eosinophilia were more frequent with bulevirtide but generally mild. No treatment-related serious adverse events occurred.

This phase 3 trial evaluated the safety and efficacy of bulevirtide in patients with chronic hepatitis D virus (HDV) infection, with or without compensated cirrhosis. Patients were randomly assigned to receive 2 mg/day, 10 mg/day of subcutaneous bulevirtide, or delayed treatment (control group). At 48 weeks, combined virologic and biochemical responses (undetectable or ≥2 log₁₀ IU/mL reduction in HDV RNA and ALT normalization) occurred in 45% (2 mg), 48% (10 mg), and 2% (control). ALT normalization and HDV RNA decline were significantly improved in both dose groups compared to control, though HBsAg levels remained unaffected. Adverse events including pruritus, injection-site reactions, and eosinophilia were more frequent with bulevirtide but generally mild. No treatment-related serious adverse events occurred.