Besifovir Dipivoxil Maleate offers comparable efficacy and safety improvements in hepatitis B patients

Hepatitis B is the cause of liver infection caused by hepatitis B virus (HBV), and long-term hepatitis B infection that lasts for more than six months is considered “chronic.” Chronic hepatitis B (CHB) is a common cause of chronic liver disease and is also associated with the development of cirrhosis and liver cancer, causing a major health care burden.

Antiviral tenophovir dikoxyl fumarate (TDF) is currently the most widely used treatment in CHB. However, long-term treatment with TDF gradually decreases renal function and bone health, and requires exploring safer long-term treatment options.

Besifovir Dipivoxil Maleate (BSV) is another drug that has been shown to have an antiviral effect comparable to TDF in stage 3 clinical trials, with improved kidney and bone safety in treated patients. However, this study was conducted on individuals who had not received treatment for CHB. In the real world, most patients with CHB have already been treated with TDF for several years.

To address this limitation, a multicenter research team led by Dr. Hyun Jun Im of the Department of Internal Medicine at Angsan Hospital, Korea University, studied the effectiveness of switching from long-term TDF to antiviral BSV in CHB patients as part of a stage 4 clinical trial. A study published online in Clinical and Molecular Hepatology on January 16, 2025, enrolled 153 patients with CHB who had been undergoing TDF treatment for more than 48 weeks. These patients were randomly selected to receive either BSV or TDF for an additional 48 weeks.

The initial aim of this study was to confirm that BSV was not inferior to TDF in terms of antiviral efficacy. This was tested by measuring the amount of HBV DNA in the patient’s blood. Among all patients who completed the assigned treatment, in this study, 100% and 98.5% of patients receiving BSV and TDF showed a virological response to HBV, with very low viral levels not detected by sensitive assays. “After switching from TDF to BSV, we also noticed that there is no antiviral resistance,” adds Dr. Yim.

More importantly, the researchers showed that patients who switched to BSV showed on average a higher percentage of changes in a parameter called estimated glomerular filtration rate indicating improved renal function. The BSV treated group showed higher bone density in the hip and spine, indicating improved bone strength.

“These results show that after switching to BSV, the adverse effects of long-term TDF may be potentially reversible due to improved renal function and improved bone density,” Dr. Yim said, highlighting the potential for BSV as a safer long-term therapy for hepatitis B.” These findings promise new hopes for patients receiving long-term antiviral treatment for hepatitis B!