The Efficacy of Prophylactic TAF for HBsAg-positive Patients Receiving bDMARDs
Status:
Not yet recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
Hepatitis B virus reactivation (HBVr) is an emerging issue and a potentially life-threatening
complication to patients with history of Hepatitis B virus (HBV) infection whose immune
system is deficient or suppressed. It is estimated that the risk of HBVr ranges 20%-50% in
hepatitis B surface antigen (HBsAg)-positive patients undergoing chemotherapy or
immunosuppressive therapy. Not only HBsAg-positive patients but also HBsAg-negative/antibody
to hepatitis B core antigen (anti-HBc)-positive patients (resolved hepatitis B) have the risk
of HBVr.
Recent studies also reported that the risk of HBVr associated with TNF-α inhibitor treatment
widely ranged from 12.3% to 62.5%. Antiviral prophylaxis by nucleos(t)ide analogues (NUCs) is
recommended for patients with high risk of HBVr according to 2018 AASLD guidance. Phase 3
studies reported that tenofovir alafenamide (Vemlidy, TAF) can effectively suppress HBV in
both HBeAg-positive and HBeAg-negative chronic hepatitis B patients, and TAF is superior to
TDF in safety profiles and ALT normalization. However, the evidence of TAF in prevention HBV
reactivation for patients with HBsAg-positive and imflammatory arthritis, who need bDMARDs
are still missing.