Article Impact Level: HIGH Data Quality: STRONG Summary of Clinical and Molecular Hepatology. https://doi.org/10.3350/cmh.2024.0819 Dr. Hyung Joon Yim et al.
Points
- This study compared the effectiveness of besifovir (BSV) to tenofovir disoproxil fumarate (TDF) in maintaining viral suppression in chronic hepatitis B patients already on long-term TDF therapy.
- After 48 weeks of treatment, BSV was shown to be non-inferior to TDF, with 100 percent of patients in the BSV group and 98.5 percent in the TDF group maintaining undetectable HBV DNA levels.
- The BSV group demonstrated slightly improved kidney function over time, while the TDF group showed a minor decline in renal performance based on estimated glomerular filtration rate measurements.
- Bone safety markers significantly improved in the BSV group, with patients experiencing increased bone mineral density in the hip and spine, unlike those who continued TDF treatment.
- The findings suggest that switching to BSV provides similar antiviral control while offering enhanced renal and bone safety, making it a potentially better long-term option for chronic hepatitis B management.
Summary
This study aimed to evaluate the efficacy and safety of switching from long-term tenofovir disoproxil fumarate (TDF) to besifovir (BSV) in patients with chronic hepatitis B (CHB). A non-inferiority trial was conducted with 153 patients who had been on TDF for ≥48 weeks and had undetectable hepatitis B virus (HBV) DNA (<20 IU/mL). These patients were randomized to receive either BSV 150 mg or TDF 300 mg for 48 weeks. The per-protocol analysis included 130 patients (64 in the BSV group and 66 in the TDF group). The primary endpoint, achieving HBV DNA <20 IU/mL, was met by 100% of patients in the BSV group and 98.5% in the TDF group. The non-inferiority margin of -0.18 was met, with a 95% confidence interval of -0.01 to 0.04 (P=1.000), showing that BSV was as effective as TDF in maintaining viral suppression.
In terms of safety, the study found that the BSV group had a slight improvement in renal function, with a mean change in estimated glomerular filtration rate (eGFR) of 1.67±11.73%, compared to a slight decline of -1.24±11.02% in the TDF group. Furthermore, bone safety was significantly improved in the BSV group, with favorable changes in bone turnover biomarkers. The BSV group also increased hip and spine bone mineral density, whereas the TDF group did not show similar improvements.
In conclusion, the study demonstrated that switching from long-term TDF to BSV in patients with CHB resulted in non-inferior antiviral efficacy while improving renal and bone safety. These findings suggest that BSV may be a preferable option for patients with CHB who require long-term antiviral therapy, offering benefits in terms of both safety and efficacy.
Link to the article: https://www.e-cmh.org/journal/view.php?doi=10.3350/cmh.2024.0819
References Yim, H. J., Seo, Y. S., Kim, J. H., Kim, W., Jung, Y. K., Jang, J. Y., Lee, S. H., Kim, Y. S., Kim, C. W., Kim, H. S., Shim, J.-J., Cho, E.-Y., Kim, I. H., Lee, B. S., Lee, J.-H., Kim, B. S., Jang, J. W., Lee, H. W., Kwon, J. H., … Yang, J. M. (2025). Switching to besifovir in patients with chronic hepatitis b receiving tenofovir disoproxil fumarate: A randomized trial. Clinical and Molecular Hepatology. https://doi.org/10.3350/cmh.2024.0819
