Is Hepatitis B Surface Antigen (HB s Ag) Enough Alone as a Screening Test Before Immunosuppressive Therapies?

Sherief Abd-Elsalam

Status: Unknown

Conditions: Hepatitis B

Treatments: Other: HBV core antibodies testing. • Real time PCR testing.

Study type: Interventional

Funder types: Other

Identifiers

NCT02799316

Rasha Abdelno

Details and patient eligibility

About

Hepatitis B virus (HBV) infection is a challenging health problem. According to the World Health Organization, an estimated 240 million individuals (3.7%) suffered from chronic HBV infection worldwide.

After acute hepatitis B virus (HBV) infection, the disappearance of hepatitis B surface antigen (HBsAg) had generally been believed to signify viral elimination. However, it now becomes clear that those subjects may have occult HBV infection which is defined as the presence of HBV DNA in the liver in the absence of HBsAg in the serum. Occult HBV infection usually accompanies antibody against hepatitis B core antigen (anti-HBc) and/or antibody against HBsAg (anti-HBs), but some cases might not have these serological markers (seronegative occult HBV infection) .

Full description

In a recent systematic review, nearly 40% of HBsAg carriers and 5% of antiHBc-positive but HBsAg-negative patients developed HBVr during TNF inhibitor therapy.

Considering the lifelong use of multiple antirheumatic drugs, we need more specific guidelines for the management of rheumatic disease patients who are scheduled to receive biological and/or non-biological DMARDs.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Any patients with rheumatic disease with hepatitis B surface antigen negative.

Exclusion criteria

• • Overt co-morbid condition.

  • Any malignancy e.g. HCC

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

rheumatic disease with HBs-ag positive

Other group

Description:

• HBV core antibodies testing. • Real time PCR testing.

Treatment:

Other: HBV core antibodies testing. • Real time PCR testing.