Bulevirtide monotherapy safe, well-tolerated in chronic hepatitis D patients
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LONDON — Bulevirtide induced a greater combined virologic and biochemical response compared with control at 48 weeks in patients with chronic hepatitis D infection, according to research.
“HDV causes the most severe form of chronic viral hepatitis with two-to-three-fold increased risk for mortality compared with HBV mono-infection,” Heiner Wedemeyer, PhD, professor and clinical director of gastroenterology, hepatology and endocrinology at Hannover Medical School in Germany, said at the International Liver Congress. “Achieving HDV viral control or cure of chronic HDV is an unmet medical need.”
In a 24-week analysis of a phase 3 study of bulevirtide (BLV) — a novel first-in-class entry inhibitor — researchers reported that monotherapy with BLV at 2 mg or 10 mg once daily was safe and had a significantly greater combined virologic and biochemical response compared with control with no active anti-HDV treatment.
Wedemeyer and colleagues enrolled 150 patients with chronic HDV (mean age, 41.8 years; 57.3% men) to three treatment groups based on the presence of compensated cirrhosis (47.3%). Arm A, the control group, received no active anti-HDV treatment for 48 weeks followed by BLV 10 mg per day for 96 weeks (n = 51), and arms B and C received immediate treatment with BLV 2 mg per day (n = 49) or 10 mg per day (n = 50) for 144 weeks. All groups entered treatment-free follow-up for additional 96 weeks.
Primary studied endpoints included undetectable HDV RNA or decrease by at least 2 log10 IU/mL from baseline (mean 5.05 log10 IU/mL) and alanine transaminase (mean 11.09 U/L) normalization at week 48. Secondary endpoints included viral response, ALT normalization and change in liver stiffness.
Researchers observed similarly superior viral and biochemical responses among patients in arms B and C at 48 weeks compared with control patients (P < .0001). They further reported BLV was safe and well-tolerated with no serious adverse events attributed to treatment, although asymptomatic elevations in total serum bile salts and injection side reactions occurred at a higher BLV dose.
“Treatment with bulevirtide was superior to control as assessed by the combined biochemical and viral response at week 48,” Wedemeyer concluded. “Management was consistent across all subgroups, including patients with liver cirrhosis. Looking at the biological endpoint alone, the proportion of undetectable HDV RNA was similar between BLV 2 mg and 10 mg groups.”
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Wedemeyer H, et al. Abstract GS006. Presented at: International Liver Congress; June 22-26, 2022; London (hybrid meeting).
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