만성 B형 간염 환자에서 Besifovir와 Tenofovir Alafenamide의 효과 및 안전성 비교

Abstract

Background : Oral antiviral agents, such as besifovir (BSV) and tenofovir alafenamide (TAF), are first-line treatments for chronic hepatitis B. Approved by the Ministry of Food and Drug Safety (MFDS) in 2017, these medications require long-term use due to challenges of achieving a ‘sterilizing cure’. This study evaluated their long-term efficacy and safety in treatment-naïve patients. Methods : This retrospective study reviewed medical records of patients aged 18 years or older who initiated treatment with BSV or TAF at a single institution between November 2017 and December 2023. Cumulative vi rological response (VR), changes in liver fibrosis and steatosis, and adverse effects, including renal impairment and hypercholesterolemia were compared between the two groups. Results : Among 603 patients, 187 were in the BSV group, and 416 in the TAF group. The BSV group demon strated a significantly (p<0.05) higher cumulative VR rate (HBV DNA <10 IU/mL) than the TAF group, while TAF was associated with a higher cumulative VR60 rate (HBV DNA <60 IU/mL, p<0.05). The BSV group also showed significantly (p<0.05) greater improvements in liver fibrosis and steatosis. However, safety outcomes showed no significant differences between the two groups over the study period. Conclusion : This study confirmed that BSV achieved higher VR and greater improvements in liver fibrosis and steatosis than TAF. By comprehensively evaluating virological, hepatic, and safety outcomes, this study provides a multifaceted comparison of the two drugs. Further prospective studies are required to validate these findings.