Treating hepatitis D with bulevirtide - Real-world experience from 114 patients

Area of Science:

• Hepatology
• Virology
• Pharmacology

Background:

• Bulevirtide is a novel entry inhibitor for Hepatitis B surface antigen.
• Hepatitis D is a severe liver disease often leading to cirrhosis and cancer.
• Bulevirtide received conditional approval for Hepatitis D treatment in July 2020.

Purpose of the Study:

• To evaluate the real-world safety and efficacy of bulevirtide monotherapy in chronic Hepatitis D patients.
• To report the first data from a large, multicenter, real-world cohort treated with bulevirtide.
• To assess virologic response and liver inflammation markers in patients receiving bulevirtide.

Main Methods:

• Retrospective data collection from 114 chronic Hepatitis D patients across 16 German hepatological centers.
• Analysis of anonymized patient data on bulevirtide treatment (2 mg daily).
• Assessment of virologic response (HDV RNA decline) and alanine aminotransferase levels.

Main Results:

• A virologic response was observed in 76% (87/114) of patients, with a mean time to response of 23 weeks.
• Hepatitis D virus (HDV) RNA breakthrough occurred in 11 patients.
• Alanine aminotransferase levels improved in most patients, irrespective of virologic response, and treatment was well-tolerated with no serious adverse events.

Conclusions:

• Bulevirtide monotherapy is safe and effective in a large real-world cohort of Hepatitis D patients in Germany.
• Further studies are needed to determine long-term benefits and optimal treatment duration.
• Real-world data supports the efficacy demonstrated in clinical trials for bulevirtide treatment.