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Paris, France – A new study evaluating the safety and tolerability of bulevirtide as a monotherapy for chronic hepatitis delta (CHD) has confirmed its effectiveness and favorable safety profile through 48 weeks of treatment. The findings were released as part of an integrated analysis of clinical trials, authored by Dr. Tarik Asselah from the Université de Paris-Cité Hôpital Beaujon and colleagues.
Chronic hepatitis D (HDV) is a rare but severe form of liver disease that only affects those already infected with hepatitis B. This condition is known for its rapid progression to cirrhosis and liver failure. Bulevirtide, a novel antiviral agent, was recently approved in Europe as a treatment for HDV. The new analysis, based on data from completed and ongoing trials, confirms that bulevirtide continues to be both safe and well-tolerated for up to one year.
Trial Design and Methodology
The clinical trials assessed bulevirtide in a range of doses, including 2 mg and 10 mg, administered as monotherapy over 48 weeks. The study combined results from three multi-center, open-label, randomized phase 2 and 3 clinical trials—MYR203, MYR204, and MYR301—conducted across seven countries: Germany, Romania, Italy, France, Russia, and Sweden.
Participants in the trials included men and women aged 18 to 65 who had chronic hepatitis delta with or without compensated cirrhosis and detectable HDV RNA. The trials also included control groups that received either pegylated interferon-alpha (Peg-IFNα) or no treatment at all.
Safety and Tolerability Findings
The study found that the most common adverse events (AEs) in the bulevirtide groups were injection-site reactions, headache, increased bile acid levels, itching, and eosinophilia. The incidence of these events was higher in the bulevirtide treatment groups (16%-20%) compared to the control group (0%).
Despite these mild to moderate adverse events, the study showed no serious AEs linked to bulevirtide therapy. Notably, there were no cases of hepatic decompensation or death in any treatment cohort. Furthermore, adverse events classified as Grade 3 or 4 were less frequent in the bulevirtide groups (3%-4%) than in the Peg-IFNα group (51%).
Conclusion
The results of this study confirm that bulevirtide is a safe and well-tolerated treatment option for patients with chronic hepatitis delta. With no new safety concerns identified over the 48-week period, the data further solidifies bulevirtide’s role in managing this potentially devastating disease.
“In conclusion, this integrated analysis of bulevirtide treatment did not identify any new safety concerns,” said Dr. Asselah. “Bulevirtide demonstrates a consistent and predictable safety profile, which is more favorable compared to Peg-IFNα alone.”
As HDV remains one of the most virulent forms of hepatitis, the ongoing development of safe, effective therapies like bulevirtide offers hope for improving patient outcomes and reducing the burden of liver disease globally.
References
- Asselah, T., Lampertico, P., Aleman, S., et al., “Bulevirtide Monotherapy Is Safe and Well Tolerated in Chronic Hepatitis Delta: An Integrated Safety Analysis of Bulevirtide Clinical Trials at Week 48,” Liver International (2024).
- Degasperi, E., Anolli, M. P., Uceda Renteria, S. C., et al., “Bulevirtide Monotherapy for 48 Weeks in Patients With HDV-Related Compensated Cirrhosis,” Journal of Hepatology, 77(6) (2022).
