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Risk of rituximab-induced hepatitis B flare after antiviral discontinuation in rheumatic patients with chronic hepatitis B virus


1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

 

  1. Division of Rheumatology, Department of Internal Medicine, National Taiwan University Hospital Hsin-Chu Branch, Taiwan.
  2. Division of Rheumatology, Department of Internal Medicine, National Taiwan University Hospital Hsin-Chu Branch, Taiwan.
  3. Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan; and Department of Medical Research, National Taiwan University Hospital, Taipei, Taiwan.
  4. Division of Rheumatology, Department of Internal Medicine, National Taiwan University Hospital Hsin-Chu Branch, Taiwan.
  5. Division of Allergy, Immunology and Rheumatology, Department of Internal Medicine, Shuang Ho Hospital, New Taipei City, Taiwan.
  6. Division of Rheumatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
  7. Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei; Hepatitis Research Center, National Taiwan University Hospital, Taipei, and Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital Bei-Hu Branch, Taipei, Taiwan.
  8. Division of Rheumatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
  9. Division of Rheumatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
  10. Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei; and Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
  11. Division of Rheumatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
  12. Division of Rheumatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. hsiehsc@ntu.edu.tw

CER17552
2024 Vol.42, N°9
PI 1830, PF 1837
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PMID: 38855955 [PubMed]

Received: 09/02/2024
Accepted : 15/04/2024
In Press: 04/06/2024
Published: 23/09/2024

Abstract

OBJECTVES: Among immunosuppressants, rituximab is most strongly associated with the risk of hepatitis B virus (HBV) reactivation in chronic HBV individuals. Current guidelines recommending antiviral prophylaxis for these patients on rituximab are predominantly based on studies in oncology. However, limited data existed for the precise risk of HBV flares, effectiveness and optimal duration of antiviral prophylaxis in rituximab-treated rheumatic patients, whose immune status and treatment regimen differ significantly from those of oncology patients. Therefore, we aimed to assess the incidence and clinical outcome of HBV reactivation in HBsAg-positive patients receiving rituximab for various autoimmune diseases who discontinue the antiviral agents.
METHODS:
A retrospective analysis was performed on 95 hepatitis B surface antigen (HBsAg)-positive patients treated with rituximab for autoimmune diseases in a single centre in Taiwan. HBV related hepatitis, defined as alanine aminotransferase (ALT) more than 3 times of baseline level and concurrent HBV reactivation, after anti-viral discontinuation, was the primary endpoint. Factors associated with HBV hepatitis flare and off-antiviral hepatitis flare were also analysed.
RESULTS:
With nucleos(t)ide analogues (NA) prophylaxis, no hepatitis flares occurred. However, without prophylaxis, 59% had flare (24.5 per 100 person-years) and 8% experienced liver decompensation. Concurrent steroid use was a dose-dependent risk factor for flare. After NA discontinuation, rituximab “retreatment” led to flares in 75% of cases and liver decompensation in 63% of patients. Stopping NAs within one-year post-rituximab, even without further rituximab treatment, resulted in a 38% flare rate.
CONCLUSIONS:
This study offers the direct evidence for the necessity of universal antiviral prophylaxis in rheumatic patients with chronic HBV receiving rituximab. After NA discontinuation, rituximab “retreatment” led to even higher flare rate and worse outcome. Patients who completed rituximab treatment should also keep antiviral agents for at least one more year to prevent hepatitis flare.

DOI: https://doi.org/10.55563/clinexprheumatol/qh1gj3

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