#South Korea #Seoul #Hepatitis B #Besifovir #Tenofovir

Introduction to Chronic Hepatitis B

Chronic Hepatitis B (CHB) remains a significant global health concern, impacting over 250 million individuals worldwide. This liver infection is caused by the Hepatitis B virus (HBV), and when it persists for more than six months, it is classified as chronic. The disease leads to severe liver conditions, including cirrhosis and liver cancer, significantly burdening healthcare systems.

Current Treatment Landscape

Today, the predominant antiviral medication for managing Chronic Hepatitis B is tenofovir disoproxil fumarate (TDF). While tenofovir is effective, continuous use has been associated with adverse effects, particularly concerning renal function and bone density. These risks necessitate the exploration of safer, more sustainable treatment alternatives.

Introducing Besifovir

Recent research by a team from the Korea University College of Medicine presents a promising alternative: besifovir dipivoxil maleate (BSV). In earlier clinical trials, besifovir demonstrated antiviral efficacy comparable to tenofovir. However, its safety profile regarding kidney and bone health offers a significant advantage—especially vital for patients on long-term therapy.

Study Overview

Under the leadership of Dr. Hyung Joon Yim from Korea University Ansan Hospital, a multicenter stage 4 clinical trial was conducted to investigate the effects of transitioning from long-term TDF treatment to besifovir. The study incorporated 153 participants diagnosed with Chronic Hepatitis B, all of whom had been undergoing TDF therapy for a minimum of 48 weeks.

These patients were randomized to receive either BSV or continue TDF treatment for an additional 48 weeks. The primary objective was to assess whether besifovir was as effective as tenofovir in managing HBV.

Findings: Antiviral Efficacy of Besifovir

The results were promising: an impressive 100% of patients on besifovir and 98.5% of those remaining on tenofovir achieved a virologic response, achieving undetectable virus levels in their blood by sensitive assays. Importantly, no antiviral resistance was observed in those switching to besifovir, suggesting that this drug could maintain efficacy while mitigating the risks associated with long-term TDF therapy.

Improvement in Renal and Bone Safety

More striking were the benefits observed in renal and bone health. Patients who switched to besifovir exhibited a notable improvement in their estimated glomerular filtration rate (eGFR), marking enhanced kidney performance. Additionally, bone density measurements indicated increased strength in the hip and spine areas among those treated with besifovir. These findings point to the fact that switching from tenofovir could reverse some adverse effects associated with prolonged treatment, making besifovir a viable option for long-term therapy.

Conclusion

Dr. Yim underscored the significance of these findings, stating, "These results demonstrate that the side effects of long-term TDF treatment may be potentially reversible with switching to BSV, reflecting improved kidney and bone health." The potential of besifovir as a safer alternative brings hope to many patients enduring the burdens of Chronic Hepatitis B. With ongoing research and development, there is optimism that besifovir could become a standard treatment, ensuring patients not only experience effective antiviral action but also maintain their overall health during treatment.

Reference

The findings of this pivotal study were published online on January 16, 2025, in the Clinical and Molecular Hepatology journal, marking a significant leap forward in the battle against Chronic Hepatitis B and providing renewed hope for patients worldwide.