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Exploring Predictive Factors for Bulevirtide Treatment Response in Hepatitis Delta-Positive Patients.

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Lower baseline anti-HBc IgG levels and specific Hepatitis D Virus RNA structures predict successful Bulevirtide treatment in coinfected patients. This finding aids in understanding treatment response for Hepatitis B/D virus coinfection.

Keywords:
Anti-HBc IgGHDVantiviral treatmentbulevirtidegenetic variability

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Area of Science:

  • Hepatology
  • Virology
  • Molecular Biology

Background:

  • Hepatitis delta virus (HDV) infection is the most severe form of viral hepatitis.
  • Bulevirtide (BLV) offers a novel therapeutic approach for HBV/HDV coinfection, but response rates vary.
  • Predicting treatment success is crucial for optimizing patient outcomes.

Purpose of the Study:

  • To identify clinical, virological, and polymorphic factors predicting Bulevirtide (BLV) treatment success in HBV/HDV-coinfected patients.
  • To analyze the impact of baseline characteristics and viral factors on treatment response.
  • To explore potential correlations between HDV RNA structure and treatment efficacy.

Main Methods:

  • Thirty HBV/HDV-coinfected patients received BLV monotherapy (2 mg/day) for 24-48 weeks.
  • Baseline and follow-up serum samples were analyzed for HDV RNA, HBV DNA, HBsAg, HBcrAg, and anti-HBc IgG.
  • Full-genome HDV sequencing, phylogenetic analysis, HDAg protein sequence analysis, and HDV RNA secondary structure analysis were performed.

Main Results:

  • 58% of patients achieved virological response (HDV RNA undetectable or ≥2 Log decline) by week 48.
  • Lower baseline anti-HBc IgG levels were significantly associated with virological response (p=0.0001).
  • HDV genotype 1e was predominant; no HDAg polymorphisms predicted response, but HDV RNA secondary structure (internal loops near editing site) may influence efficacy.

Conclusions:

  • Lower baseline anti-HBc IgG levels are a strong predictor of positive virological response to BLV in HBV/HDV coinfection.
  • The liver's inflammatory state, indicated by anti-HBc IgG levels, appears to influence treatment success.
  • HDV RNA secondary structure, particularly editing efficiency, may play a role in BLV treatment response, warranting further investigation.