Bulevirtide induces a virologic, biochemical response in chronic hepatitis D
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Key takeaways:
- Hepatitis D virus RNA was undetectable in up to 20% of patients with chronic hepatitis D treated with bulevirtide.
- Bulevirtide normalized alanine transaminase in up to 56%.
Bulevirtide was safe and increased the proportion of patients with undetectable hepatitis D virus RNA among those in both the 2 mg and 10 mg dosage groups, according to data published in The New England Journal of Medicine.
The results were also presented during the EASL Congress.
“Because pegylated interferon-alfa has limitations, achieving HDV control is definitely an unmet clinical need and bulevirtide (Gilead Sciences) is one option,” Heiner Wedemeyer, MD, professor in the department of gastroenterology, hepatology and endocrinology at Medizinische Hochschule Hannover, said during the presentation at EASL Congress. “The drug has conditionally been approved by the European Medicines Agency already in 2020.”
In an ongoing, randomized phase 3 trial, Wedemeyer and colleagues assessed the safety and effectiveness of bulevirtide monotherapy among 150 patients (mean age, 42 years; 57% men; 83% white; 47% cirrhotic) with chronic HDV. Patients received either subcutaneous bulevirtide at 2 mg (n = 49) or 10 mg (n = 50) per day for 144 weeks. The 51 patients in the control group received no treatment for 48 weeks followed by subcutaneous bulevirtide 10 mg per day for 96 weeks.
The primary endpoint was a combined response of undetectable HDV RNA level or a level that decreased by at least 2 log10 IU/mL and alanine transaminase at week 48.
Researchers observed a primary combined endpoint response among 45% of patients in the 2 mg group, 48% of patients in the 10 mg group and 2% of patients in the control group. This response was “significantly greater” among patients in both the 2 mg (difference, 43%: 96% CI, 27%-58%) and 10 mg (difference, 46%; 96% CI, 30%-61%) dosage groups compared with placebo. Further results showed HDV RNA was undetectable in 12% and 20%, respectively, and ALT normalized among 51% (vs. control, 39%; 95% CI, 20%-56%), 56% (vs. control, 44%; 95% CI, 26%-60%) and 12%.
No treatment-related serious adverse events occurred.
“In this ongoing trial involving patients with chronic hepatitis D who received bulevirtide (2 mg or 10 mg) or no treatment for the first 48 weeks, a significantly greater percentage of patients in bulevirtide groups than in the control group had a virologic and biochemical response (primary combined end-point response), as assessed by analysis of the HDV RNA and ALT levels, respectively, at week 48,” Wedemeyer and colleagues wrote. “This surrogate endpoint is considered to be a reasonably likely predictor of improved clinical outcomes in patients with hepatitis D; however, longer-term data are needed to confirm the clinical benefit of bulevirtide.”
Reference:
- Wedemeyer H, et al. Abstract OS-068: Efficacy and safety at 96 weeks of bulevirtide 2 mg or 10 mg monotherapy for chronic hepatitis D: Results from an interim analysis of a phase 3 randomized study. Presented at: EASL Congress; June 21-23, 2023; Vienna (hybrid meeting).
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