NCT02799316

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

Is Hepatitis B Surface Antigen (HB s Ag) Enough Alone as a Screening Test for Hepatitis B Virus Infection in Rheumatic Disease Patients Before Starting Immunosuppressive Therapies??

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sherief Abd-Elsalam · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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) .

Detailed 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.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
OTHER	HBV core antibodies testing. • Real time PCR testing.	* HBV core antibodies testing in HBV surface antigen negative patients. * Real time PCR testing for those having positive HBc antibodies.

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-12-01
• Completion: 2018-01-01
• First posted: 2016-06-14
• Last updated: 2017-06-20

Locations

1 site across 1 country: Egypt