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Farnesoid X receptor agonist for the treatment of chronic hepatitis B: A safety study

Robin Erken1, Patrice Andre2, Elise Roy3

  • 1Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Duivendrecht, The Netherlands.

Journal of Viral Hepatitis
|September 1, 2021
PubMed

Insights

Vonafexor, a farnesoid X receptor (FXR) agonist, demonstrated safety and a potential antiviral effect in chronic hepatitis B (CHB) patients. Further trials are needed to confirm its therapeutic potential in treating this liver disease.

Area of Science:

  • Hepatology and Viral Hepatitis Research
  • Pharmacology and Drug Development
  • Molecular Biology and Receptor Signaling

Background:

  • The nuclear farnesoid X receptor (FXR) is crucial for bile acid homeostasis and a therapeutic target for metabolic liver diseases.
  • FXR activation inhibits hepatitis B virus (HBV) replication in preclinical models, suggesting potential for treating chronic hepatitis B (CHB).

Purpose of the Study:

  • To evaluate the safety and tolerability of Vonafexor, an FXR agonist, in patients with CHB.
  • To assess the antiviral efficacy of Vonafexor, alone and in combination, on HBV markers.

Main Methods:

  • A Phase Ib, double-blind, placebo-controlled trial involving 73 CHB patients.
  • Patients received varying doses of oral Vonafexor or placebo, with some in combination with pegylated-interferon-α2a.
  • Safety, tolerability, and changes in HBV DNA, HBsAg, HBcrAg, and pgRNA were monitored over 29 days of treatment and 35 days of follow-up.

Main Results:

  • Vonafexor was generally well-tolerated, with moderate gastrointestinal events as the most common adverse events.
  • Pruritus was more frequent with twice-daily dosing compared to once-daily regimens.
  • Vonafexor monotherapy (400 mg once daily) reduced HBsAg levels, and combination therapy decreased HBcrAg and pgRNA.

Conclusions:

  • Vonafexor is safe and well-tolerated in CHB patients, with observed reductions in key HBV markers.
  • The findings suggest a potential antiviral effect of Vonafexor in CHB treatment.
  • Larger clinical trials are warranted to fully evaluate the therapeutic potential of Vonafexor for CHB.
Keywords:
HBV therapyVonafexorcccDNA transcriptionfarnesoid X receptorphase Ib

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