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Retroviruses have a single-stranded RNA genome that undergoes a special form of replication. Once the retrovirus has entered the host cell, an enzyme called reverse transcriptase synthesizes double-stranded DNA from the retroviral RNA genome. This DNA copy of the genome is then integrated into the host’s genome inside the nucleus via an enzyme called integrase. Consequently, the retroviral genome is transcribed into RNA whenever the host’s genome is transcribed, allowing the...
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Related Experiment Video

Updated: Aug 4, 2025

Stem Cell-Derived Viral Ag-Specific T Lymphocytes Suppress HBV Replication in Mice
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Treating hepatitis D with bulevirtide - Real-world experience from 114 patients.

Christopher Dietz-Fricke1, Frank Tacke2, Caroline Zöllner2

  • 1Department of Gastroenterology, Hepatology and Endocrinology at Hannover Medical School, Hannover, Germany.

JHEP Reports : Innovation in Hepatology
|April 7, 2023
PubMed
Summary

Bulevirtide monotherapy shows significant efficacy and safety in treating chronic hepatitis D in a large real-world German cohort. Most patients achieved virologic response, with improved liver inflammation markers and good tolerability.

Keywords:
Antiviral treatmentBulevirtideHepatitis DReal world experienceViral hepatitis

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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.