Risk of Hepatitis Flare in Patients With Previous Hepatitis B Virus Exposure Amongst Patients
NCT ID: NCT04356404
Last Updated: 2022-01-28
Study Results
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Basic Information
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TERMINATED
68 participants
OBSERVATIONAL
2020-05-01
2022-01-12
Brief Summary
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Detailed Description
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Biologics is one of the mainstay treatments for many autoimmune diseases, including inflammatory bowel disease (IBD), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE), psoriasis etc. The incidence of IBD has increased rapidly in Hong Kong over the past 30 years. The age-adjusted incidence of IBD in Hong Kong has rose from 0.10 per 100,000 individuals in 1985 to 3.12 per 100,000 individuals in 2014. The reported prevalence of RA in Hong Kong was 0.35% while the reported prevalence of SLE in Hong Kong was 0.1% with annual incidence of 6.7 per 100,000 individuals. It is well known that treatment with biological agent like anti-CD20 monoclonal antibody (rituximab) in patients with OBI can lead to fulminant hepatitis B flare. Recently, anti-tumor necrosis factor alpha (TNF α) has been widely used in patients with inflammatory bowel disease and various rheumatological diseases. Risk of hepatitis B reactivation after anti-TNF α has been reported, but actual risk remains controversial. In a report from Japan including 135 rheumatoid arthritis patients with previous HBV infections, 17/135 (12.6%) had HBV reactivation after receiving immunosuppressants and patients who were treated with biologics were more frequent to develop HBV reactivation compared to those who were not on biologics. In another study, 9/168 (5%) anti-HBc positive patients developed HBV reactivation after receiving anti-TNF α and one patient died due to fulminant liver failure.However, another three studies revealed low rates of HBV reactivation (0-2%) amongst rheumatology patients with previous HBV infections receiving anti-TNF α. The European Crohn's and Colitis Organisation (ECCO) suggested routine antiviral prophylaxis for patients with previous HBV infection starting biologics is not recommended. Instead, regular monitoring of ALT/ AST, change in HBV serology and HBV DNA every 1 to 3 months should be performed. In 2015, the American Gastroenterology Association (AGA) has developed guideline on the prevention and treatment of hepatitis B virus reactivation during immunosuppressive therapy. It classifies patients receiving anti-TNF α as moderate risk of developing HBV reactivation and antiviral prophylaxis is preferred over monitoring alone, but it is a weak recommendation. Therefore, it is now still uncertain whether prophylactic anti-viral should be given for patients with previous HBV exposure before starting anti-TNF α.
With the advancement of technology, there are now more biological agents and small molecules for the treatment of IBD and various rheumatological conditions. These include anti-integrin, cytokine inhibitors, and small molecules e.g. JAK inhibitors. Cytokine inhibitor, ustekinumab (anti-IL12/23), has been reported to be leading to hepatitis reactivation in a psoriasis patient who has past HBV infection.\[26\] Whether these agents can lead to hepatitis flare in patients with past HBV exposure remains largely unknown.
Based on the compelling data, the investigators hypothesize that use of biologic modifier therapies in patients with occult hepatitis B infection will lead to hepatitis flare. The investigators aim to assess the rate of hepatitis flare while on biological modifier therapies in both retrospective population-based database and prospectively in patients who are on biological modifier therapies.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Prospective group
Patients will be followed up until development of hepatitis flare or at 2 years after study recruitment. We plan to recruit 150 patients for the prospective cohort.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Positive for anti-HBc OR
* Positive for anti-HBs and born before year 1988
Exclusion Criteria
* Concomitant HCV and/ or HIV infection
* Already on HBV anti-viral
* Refuse to consent
* Baseline ALT \> 80 IU/ml
18 Years
ALL
No
Sponsors
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University of Malaya
OTHER
Chinese University of Hong Kong
OTHER
Responsible Party
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Mak Wing Yan
Assistant Professor
Principal Investigators
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WingYan Mak, MRCP
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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The Chinese University of Hong Kong
Hong Kong, , Hong Kong
Countries
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References
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Other Identifiers
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HEP-FLARE_Protocol_20210604_V5
Identifier Type: -
Identifier Source: org_study_id
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