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Bulevirtide Monotherapy or in Combination for Chronic Hepatitis Delta: 2025 Update
Pietro Lampertico1,2,3, Maria Paola Anolli1,2,3, Katja Steppich3,4,5,6
1Division of Gastroenterology and Hepatology, Foundation IRCCS ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Journal of Viral Hepatitis
|November 25, 2025
Summary
Chronic hepatitis Delta (CHD) is aggressive, but bulevirtide (BLV) offers new hope. This review examines BLV
Area of Science:
- Hepatology and virology, focusing on viral hepatitis and liver disease.
- Pharmacology and therapeutics, specifically antiviral drug development.
- Public health and epidemiology, addressing the global prevalence of viral infections.
Background:
- Chronic hepatitis Delta (CHD) is the most aggressive form of viral hepatitis, characterized by accelerated cirrhosis, hepatic decompensation, and hepatocellular carcinoma (HCC) risk.
- Hepatitis Delta virus (HDV) requires Hepatitis B virus surface antigen (HBsAg) for entry, but current nucleos(t)ide analogue therapies are ineffective against CHD.
- Global HDV prevalence in HBsAg+ patients is estimated at 2% (Polaris Observatory, 2024), with significant regional variations, notably high rates in Mongolia.
Purpose of the Study:
- To review the efficacy, effectiveness, and safety of bulevirtide (BLV) in treating Chronic Hepatitis Delta.
- To synthesize evidence from clinical trials and real-world studies on BLV, both as monotherapy and in combination with pegylated interferon-alpha (PegIFNα).
- To propose treatment strategies for CHD based on disease severity and patient profiles, considering the evolving therapeutic landscape.
Main Methods:
- Systematic review and synthesis of current evidence on bulevirtide (BLV) efficacy and safety.
- Analysis of data from clinical trials (Phase II and III) and real-world studies.
- Evaluation of BLV's role as monotherapy and in combination with pegylated interferon-alpha (PegIFNα).
Main Results:
- Bulevirtide (BLV), an entry inhibitor targeting the NTCP receptor, has shown efficacy and tolerability in treating compensated CHD.
- The European Medicines Agency (EMA) granted conditional approval for BLV in 2020 and full approval in 2023.
- BLV demonstrates potential in managing CHD, with ongoing recommendations for its use until clinical benefit is proven.
Conclusions:
- Bulevirtide (BLV) represents a significant advancement in the treatment of Chronic Hepatitis Delta (CHD).
- Further research and real-world data are crucial for optimizing BLV treatment strategies and understanding long-term outcomes.
- The review aims to guide clinical practice by proposing tailored treatment approaches for CHD patients.
Keywords:
HDVHDV RNAHDV/HIV coinfectionbulevirtidechronic hepatitis Deltacombined responsecompensated cirrhosisentry inhibitorvirological responseMore Related Videos
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