ArticleJournal of hepatology2022
Safety and effectiveness of up to 3 years' bulevirtide monotherapy in patients with HDV-related cirrhosis.
Article in Journal of hepatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.
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Who cites it
25 citing papers in PubMed, 65 citations in OpenAlex.
- Hepatitis B virus and hepatitis D virus co-infection complicated by autoimmune hepatitis: Two case reports.World journal of clinical cases · 2025Article
- Low coverage of hepatitis D virus testing in individuals with hepatitis B virus and HIV, the Netherlands, 2000 to 2022.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2025Article
- Multisociety consensus recommendations on hepatitis delta virus infection.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2025Article
- Chronic Hepatitis D Virus Infection and Its Treatment: A Narrative Review.Microorganisms · 2024Review
- Enrichment Reveals Extensive Integration of Hepatitis B Virus DNA in Hepatitis Delta Virus-Infected Patients.The Journal of infectious diseases · 2024Article
- Current and future therapeutic options for chronic hepatitis D virus infection.Frontiers in cellular and infection microbiology · 2024Review
- Long-Term Treatment with Bulevirtide in Patients with Chronic Hepatitis D and Advanced Chronic Liver Disease.Canadian journal of gastroenterology & hepatology · 2024Article
- Advances and Challenges in Managing Hepatitis D Virus: Evolving Strategies.Current hepatology reports · 2024Article
- Hepatitis D Virus and HBsAg Dynamics in the era of new Antiviral Treatments.Current gastroenterology reports · 2023Review
- New Treatment Options in Chronic Hepatitis B: How Close Are We to Cure?Infectious diseases & clinical microbiology · 2023Review
- Efficacy and safety of compassionate use for rare diseases: a scoping review from 1991 to 2022.Orphanet journal of rare diseases · 2023Article
- Broad-spectrum activity of bulevirtide against clinical isolates of HDV and recombinant pan-genotypic combinations of HBV/HDV.JHEP reports : innovation in hepatology · 2023Article
- Long-term follow-up of patients discontinuing bulevirtide treatment upon long-term HDV-RNA suppression.JHEP reports : innovation in hepatology · 2023Article
- Recent treatment advances and practical management of hepatitis D virus.Clinical medicine (London, England) · 2023Review
- The Role of Antiviral Prophylaxis in Preventing HBV and HDV Recurrence in the Setting of Liver Transplantation.Viruses · 2023Review
- Treating hepatitis D with bulevirtide - Real-world experience from 114 patients.JHEP reports : innovation in hepatology · 2023Article
- Epidemiology, presentation, and therapeutic approaches for hepatitis D infections.Expert review of anti-infective therapy · 2023Review
- Immune microenvironment changes of liver cirrhosis: emerging role of mesenchymal stromal cells.Frontiers in immunology · 2023Review
- Bulevirtide in the Treatment of Hepatitis Delta: Drug Discovery, Clinical Development and Place in Therapy.Drug design, development and therapy · 2023Review
- [Treatment and challenges of bulevirtide in chronic hepatitis D].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2022Article
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Authors and funding
19 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The entry inhibitor bulevirtide (BLV) received conditional approval from the EMA in July 2020 for the treatment of adult patients with compensated chronic hepatitis delta. However, the effectiveness and safety of BLV administered as monotherapy beyond 48 weeks in difficult-to-treat patients with HDV-related cirrhosis is presently unknown. Herein, we describe the first patients with HDV-related compensated cirrhosis who were treated with BLV (10 mg/day as a starting dose) for up to 3 years on a compassionate use program. Patients were also monitored for HBcrAg and HBV RNA levels, and HDV- and HBV-specific T-cell markers. In the patient who stopped BLV at week 48, after achieving a virological and biochemical response, the initial virological and biochemical rebound was followed by alanine aminotransferase normalization coupled with low HDV RNA and HBsAg levels. In the 2 patients treated continuously for 3 years, virological and biochemical responses were maintained throughout the treatment period even after dose reduction. In a patient with advanced compensated cirrhosis, liver function tests significantly improved, esophageal varices disappeared, and histological/laboratory features of autoimmune hepatitis resolved. Overall, no safety issues were recorded, as bile salt increase was asymptomatic. While serum HBV RNA levels remained undetectable in all patients, HBV core-related antigen levels showed a progressive, yet modest decline during long-term BLV treatment. No HDV-specific interferon-γ-producing T cells were detected, neither after HDV reactivation (after BLV withdrawn in Patient 1) nor during 3 years of BLV treatment. In conclusion, this report shows that continuous administration of BLV monotherapy for 3 years leads to excellent virological and clinical responses in patients with HDV-related cirrhosis who had contraindications to interferon-based therapies.
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