Lee Jae Seung, Lee Sung Won, Lee Hae Lim, Yoo Jeong-Ju, Seo Yeon Seok, Yu Su Jong, Yim Hyung Joon, Jung Young Kul, Moon Jisu, Lee Hye Won, Kim Mi Na, Kim Beom Kyung, Park Jun Yong, Kim Do Young, Ahn Sang Hoon, Kim Sang Gyune, Kim Seung Up
Department of Internal Medicine, Yonsei University College of Medicine, Yonsei-Ro 50-1, Seodaemun-Gu, Seoul, 03722, South Korea.
Department of Internal Medicine, College of Medicine, Bucheon St. Mary's Hospital, The Catholic University of Korea, Bucheon, 14647, South Korea.
Sci Rep. 2025 Aug 29;15(1):31879. doi: 10.1038/s41598-025-13456-8.
Besifovir dipivoxil maleate (BSV) has potent antiviral efficacy against chronic hepatitis B (CHB). This study investigated the efficacy of BSV in reducing hepatocellular carcinoma (HCC) development compared to other antiviral therapy (AVT) agents. We conducted a retrospective cohort study on treatment-naïve patients with CHB who initiated an AVT between 2017 and 2022 with BSV (n = 486), entecavir (ETV) (n = 852), tenofovir alafenamide (TAF) (n = 801), or tenofovir disoproxyl fumarate (TDF) (n = 750). The incidence and hazard ratio (HR) of HCC were calculated. The incidence of HCC in BSV users (n = 6, 4.3 per 1000 person-years [PYs]) was similar to that in TAF users (n = 21, 9.2 per 1000 PYs, log-rank P = 0.086, HR = 2.191, 95% confidence interval [CI] 0.884-5.434), but significantly lower than that in ETV users (n = 38, 12.5 per 1000PYs, log-rank P = 0.026, HR = 2.627, 95% CI 1.103-6.255) and TDF users (n = 32, 12.3 per 1000PYs, log-rank P = 0.028, HR = 2.623, 95% CI 1.090-6.311). Similarly, compared to BSV users, the adjusted HRs for ETV, TAF, and TDF users were higher after stabilized inverse probability of treatment weighting (2.836, 2.784, and 3.294, respectively) and pairwise propensity score matching (3.200, 3.250, and 3.750, respectively) (all P < 0.05). BSV demonstrated comparable efficacy in HCC reduction compared to other AVTs.
马来酸双异戊酰氧甲基苯磷酯（BSV）对慢性乙型肝炎（CHB）具有强大的抗病毒疗效。本研究调查了与其他抗病毒治疗（AVT）药物相比，BSV在降低肝细胞癌（HCC）发生风险方面的疗效。我们对2017年至2022年间开始接受AVT治疗的初治CHB患者进行了一项回顾性队列研究，这些患者分别使用了BSV（n = 486）、恩替卡韦（ETV）（n = 852）、替诺福韦艾拉酚胺（TAF）（n = 801）或替诺福韦酯（TDF）（n = 750）。计算了HCC的发病率和风险比（HR）。使用BSV的患者中HCC的发病率（n = 6，每1000人年[PYs]为4.3例）与使用TAF的患者（n = 21，每1000 PYs为9.2例，对数秩检验P = 0.086，HR = 2.191，95%置信区间[CI] 0.884 - 5.434）相似，但显著低于使用ETV的患者（n = 38，每1000 PYs为12.5例，对数秩检验P = 0.026，HR = 2.627，95% CI 1.103 - 6.255）和使用TDF的患者（n = 32，每1000 PYs为12.3例，对数秩检验P = 0.028，HR = 2.623，95% CI 1.090 - 6.311）。同样，与使用BSV的患者相比，在稳定的逆概率治疗加权后（分别为2.836、2.784和3.294）以及成对倾向评分匹配后（分别为3.200、3.250和3.750），ETV、TAF和TDF使用者的调整后HR更高（所有P < 0.05）。与其他AVT药物相比，BSV在降低HCC风险方面显示出相当的疗效。
