Korea University Study Identifies Safer Option for Long-Term Hepatitis B Treatment

Korea: A new clinical study by researchers at Korea University has found that switching from the widely used antiviral tenofovir disoproxil fumarate (TDF) to besifovir dipivoxil maleate (BSV) significantly improves kidney function and bone health in patients with chronic hepatitis B (CHB), without compromising antiviral effectiveness.

CHB, a liver infection caused by the hepatitis B virus (HBV), affects over 250 million people globally. It is a major cause of liver-related complications, including cirrhosis and liver cancer. TDF has long been the standard treatment due to its strong antiviral activity, but its prolonged use has been linked to gradual deterioration in renal function and loss of bone density, raising concerns for long-term patient safety.

BSV is another antiviral agent that previously demonstrated similar efficacy to TDF in untreated CHB patients during a phase 3 clinical trial, while offering better safety for kidneys and bones. However, most real-world patients have already been on TDF for years, making it essential to investigate the effects of switching treatments mid-course.

To address this, a multicenter phase 4 clinical trial led by Dr. Hyung Joon Yim from Korea University Ansan Hospital evaluated 153 CHB patients who had been on TDF for at least 48 weeks. These individuals were randomly assigned to continue TDF or switch to BSV for another 48 weeks.

The primary goal was to assess whether BSV maintained comparable antiviral efficacy. Results showed that 100% of patients on BSV and 98.5% of those on TDF achieved virologic suppression, with undetectable HBV DNA levels. Additionally, no cases of antiviral resistance were observed after switching to BSV, indicating stable viral control.

Importantly, the study revealed that patients who switched to BSV experienced significant improvements in kidney function, measured by an increase in the estimated glomerular filtration rate (eGFR). They also showed higher bone mineral density at the hip and spine compared to those who remained on TDF, highlighting the added benefit of BSV in preserving long-term skeletal health.

“These findings suggest that the adverse effects of prolonged TDF therapy—particularly concerning kidneys and bones—may be reversible with BSV,” said Dr. Yim. He emphasized the potential of BSV as a safer and effective long-term therapy for managing CHB. The results, published on January 16, 2025, in Clinical and Molecular Hepatology, offer new hope for millions undergoing chronic hepatitis B treatment worldwide.