Background: Reactivation of hepatitis B virus (HBV) is one of the most important side effects in IBD patients with HBV infection treated with anti-TNF-alpha agents. We investigated the rate of prophylaxis and the risk of HBV reactivation in HBV infected patients with IBD receiving anti-TNF-alpha therapy.
Methods: This was a retrospective multicenter study including 14 academic teaching hospitals in Korea. IBD patients with HBV infection (HBsAg-positive) who treated with anti-TNF-alpha agents were enrolled. Medical records of patients were reviewed and data were collected using web-based case report form.
Results: A total of 61 patients (18 UC, 43 CD) were included. 70% were male and mean age at diagnosis was 34.9±12.0 years. Indications for anti-TNF-alpha therapy were steroid-dependency, refractoriness to conventional therapies, or fistulizing disease. Among 43 patients who tested serum HBV-DNA levels, 35 (81%) were positive for HBV-DNA prior to anti-TNF-alpha therapy. Only half of the patients (51%) received prophylactic anti-viral agents. During the follow-up of median 24 months, 16.4% of patients experienced HBV reactivation, of which 6 patients (60%) were taking concomitant azathioprine. Median duration of anti-TNF-alpha therapy before HBV reactivation was 9 months. HBV reactivation was managed by change or adding of anti-viral agents in 6 patients, discontinuing ant-TNF-alpha in 1 patient, and combination of both in 2 patients, achieving virological response in most patients (90%). HBV reactivation was more frequent in non-prophylaxis group than prophylaxis group (10% vs 24.1%, p=0.15). No other predictors for HBV reactivation were identified. There was no difference in the rates of IBD flare, IBD-related surgery or hospitalization between two groups.
Conclusions: HBV reactivation was not infrequent in HBsAg-positive IBD patients treated with anti-TNF-alpha agents. Prophylaxis for HBV reactivation and careful monitoring should be performed for such patients.