The Efficacy of Prophylactic TAF for HBsAg-positive Patients Receiving bDMARDs

Launched by TAIPEI VETERANS GENERAL HOSPITAL, TAIWAN · Aug 5, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called tenofovir alafenamide (TAF) to prevent the reactivation of the Hepatitis B virus (HBV) in patients who have a history of HBV infection and are receiving specific treatments for inflammatory arthritis. These treatments, known as bDMARDs, can weaken the immune system and increase the risk of HBV reactivation, which can be dangerous. Researchers want to see if TAF can effectively protect these patients from this risk.

To be eligible for the trial, participants must be at least 20 years old, have a history of chronic hepatitis B (specifically HBsAg-positive), and be diagnosed with inflammatory arthritis. They should also be starting bDMARD treatment within the next four weeks and have not taken certain antiviral medications in the past six months. Those who join the study can expect to receive close monitoring and care while receiving TAF to see how well it helps prevent HBV reactivation during their arthritis treatment. It's important to note that individuals with severe liver disease, certain active infections, or other serious health issues may not be able to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \>=20 years old;
• • History of chronic hepatitis B with HBsAg-positive;
• • Both HBeAg-positive and HBeAg-negative are allowed;
• • Inflammatory arthritis (including psoriatic arthritis);
• • On bDMARDs treatment or will start bDMARDs within in 4 weeks. The bDMARDs included all anti-TNF-α agents, rituximab (anti-CD20 monoclonal antibody), tocilizumab (anti-interleukin 6 receptor monoclonal antibody), abatacept (cytotoxic T-lymphocyte-associated antigen 4 immunoglobulin), and all new biologics with indication of IA treatment;
• • No NUCs treatment in recent 6 months;
• • No limitation of the baseline HBV DNA level;
• • Total bilirubin level \<2 mg/dL;
• • ALT \< 2x ULN (\<80 U/L).
• Exclusion Criteria:
• • Child-Pugh class \>B7;
• • Active EV bleeding within 4 weeks;
• • History of hepatic encephalopathy or intractable ascites;
• • Coexist with other primary liver diseases, such as active chronic hepatitis C, hepatitis D, autoimmune hepatitis, or Wilson's disease. (\*HCV RNA undetectable is allowed to enroll);
• • Active malignancy;
• • Pregnant women.