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Besifovir therapy improves hepatic histology and reduces covalently closed circular DNA in chronic hepatitis B patients
Hyung Joon Yim 1 , Won Kim 2 , Sang Hoon Ahn 3 , Young Kul Jung 1 , Soon Ho Um 1 , Joo Hyun Sohn 4 , Jae Young Jang 5 , Dong Joon Kim 6 , Eun-Sook Park 7 , So Young Jin 8 , Kyun-Hwan Kim 9
Affiliations
Affiliations
1
Department of Internal Medicine, Korea University College of Medicine.
2
Department of Internal Medicine, Seoul National University College of Medicine, Seoul Metropolitan Government Boramae Medical Center.
3
Department of Internal Medicine, Yonsei University College of Medicine.
4
Department of Internal Medicine, Hanyang University College of Medicine.
5
Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul.
6
Department of Internal Medicine, Hallym University College of Medicine, Chuncheon.
7
Department of Pharmacology, Center for Cancer Research and Diagnostic Medicine, Konkuk University School of Medicine.
8
Department of Pathology, Soonchunhyang University College of Medicine, Seoul.
9
Department of Precision Medicine, Sungkyunkwan University, School of Medicine, Suwon, Republic of Korea.
PMID: 34653281 DOI: 10.1111/jgh.15710
Abstract
Background/aims: Besifovir dipivoxil maleate (BSV) was reported to have comparable antiviral efficacy and superior renal and bone safety to tenofovir disoproxil fumarate (TDF) in chronic hepatitis B (CHB) patients. The present study aims to evaluate changes of liver histology and intrahepatic covalently closed circular DNA (cccDNA) levels by BSV treatment in comparison with TDF therapy.
Methods: This is a subset study of the phase 3 trial comparing BSV with TDF. Among them, only CHB patients willing to participate in a histologic evaluation study were enrolled. Liver histologic examination and intrahepatic cccDNA quantification were performed.
Results: A total of 46 CHB patients received liver biopsies (BSV, n = 29; TDF, n = 17). After 48 weeks of treatment, virological response rate was comparable between the groups (P = 0.707). Follow-up liver biopsies showed that necroinflammation was significantly improved in the both groups. However, the histological response rate defined as the proportion of subjects whose modified histologic activity index score decreased by ≥2 without deterioration in fibrosis was higher in the BSV group than in the TDF group (77.8% versus 36.4%, P = 0.048). The proportion of subjects with Ishak fibrosis score 3 or more decreased from 77.7% to 55.5% in the BSV and that decreased from 72.7% to 45.4% in the TDF group. The intrahepatic cccDNA significantly decreased from baseline after 48 weeks of BSV or TDF treatment (P <0.001) without intergroup differences (P = 0.349).
Conclusions: BSV therapy improves hepatic histology and decreases intrahepatic cccDNA in CHB patients.
Keywords: Besifovir; Chronic hepatitis B; Fibrosis; Histology; Necroinflammation.
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