Long-term safety of anti-TNF treatment in patients with rheumatic diseases and chronic or resolved hepatitis B virus infection.
OBJECTIVE
The aim of this prospective study was to examine the safety of anti-tumour necrosis factor (TNF) therapy in patients with rheumatic disease and hepatitis B virus (HBV) infection.


METHODS
14 patients with chronic HBV infection, 19 HBV-vaccinated patients and 19 patients with resolved HBV infection were included in the study. All HBV-infected patients received combination therapy with oral antivirals and anti-TNF agents. During treatment the levels of hepatitis B surface antibodies (anti-HBs) in HBV-vaccinated patients and of serum HBV DNA in patients with chronic or resolved HBV infection were monitored.


RESULTS
No viral reactivation was observed in patients with resolved HBV infection while anti-HBs titres decreased during anti-TNF treatment in vaccinated patients, similarly to patients treated with methotrexate alone. None of the HBV-infected patients developed liver decompensation or a significant increase in alanine aminotransferase levels. One patient (7%) treated with lamivudine and etanercept showed viral reactivation due to the emergence of a lamivudine-resistant mutant strain.


CONCLUSIONS
Anti-TNF agents represent a safe option for patients with chronic HBV infection when combined with antiviral therapy, as well as in patients previously exposed to HBV receiving no HBV prophylaxis. Resistant HBV strains may arise in patients with chronic hepatitis B, necessitating the initial use of anti-HBV agents with a low risk of resistance.
Vassilopoulos
D
D
2nd Department of Medicine, Hippokration General Hospital, Athens University School of Medicine, 114 Vass. Sophias Avenue, Athens 115 27, Greece. dvassilop@med.uoa.gr
Apostolopoulou
A
A
Hadziyannis
E
E
Papatheodoridis
G V
GV
Manolakopoulos
S
S
Koskinas
J
J
Manesis
E K
EK
Archimandritis
A I
AI
D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000998:Antiviral Agents / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000150:complications / Q000188:drug therapy*; D024882:Drug Resistance, Viral; D005260:Female; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines; D006515:Hepatitis B virus / Q000187:drug effects / Q000502:physiology; D019694:Hepatitis B, Chronic / Q000150:complications* / Q000188:drug therapy / Q000517:prevention & control; D006801:Humans; D019259:Lamivudine / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D025242:Spondylarthropathies / Q000150:complications / Q000188:drug therapy*; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*; D014775:Virus Activation / Q000187:drug effects
D018501:Antirheumatic Agents; D000998:Antiviral Agents; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D014409:Tumor Necrosis Factor-alpha; D019259:Lamivudine