Clin Mol Hepatol.
2025 Jan;31(1):213-226. 10.3350/cmh.2024.0640.
Antiviral therapy for chronic hepatitis B with mildly elevated aminotransferase: A rollover study from the TORCH-B trial
- Hsu YC
1,2,3,4 - Chen CY5
- Tseng CH2,6
- Chen CC7
- Lee TY8,9
- Bair MJ10,11
- Chen JJ12
- Huang YT13
- Chang IW14,15
- Chang CY3,16
- Wu CY4,17
- Wu MS7
- Mo LR18
- Lin JT1
- Affiliations
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- 1Division of Gastroenterology and Hepatology, E-Da Hospital, Kaohsiung, Taiwan
- 2School of Medicine, College of Medicine, I-Shou University, Kaohsiung, Taiwan
- 3Division of Gastroenterology and Hepatology, Department of Internal Medicine, Fu-Jen Catholic University Hospital, Fu-Jen Catholic University, New Taipei, Taiwan
- 4Institute of Biomedical Informatics, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan
- 5Division of Gastroenterology and Hepatology, Chia-Yi Christian Hospital, Chia-Yi, Taiwan
- 6Division of Gastroenterology and Hepatology, E-Da Cancer Hospital, Kaohsiung, Taiwan
- 7Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
- 8Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan
- 9School of Medicine, Chung Shan Medical University, Taichung, Taiwan
- 10Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taitung Mackay Memorial Hospital, Taitung, Taiwan
- 11Mackay Medical College, New Taipei, Taiwan
- 12Department of Internal Medicine, Chi-Mei Medical Center, Liouying Branch, Tainan, Taiwan
- 13Institute of Statistical Science, Academia Sinica, Taipei, Taiwan
- 14Department of Pathology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan
- 15Department of Clinical Pathology, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan
- 16School of Medicine, College of Medicine, Fu Jen Catholic University, New Taipei, Taiwan
- 17Division of Translational Research, Department of Medical Research, Taipei Veterans General Hospital, Taipei, Taiwan
- 18Department of Internal Medicine, Tainan Municipal Hospital, Tainan, Taiwan
- KMID: 2563421
- DOI: http://doi.org/10.3350/cmh.2024.0640
Abstract
- Background/Aims
Treatment indications for patients with chronic hepatitis B (CHB) remain contentious, particularly for patients with mild alanine aminotransferase (ALT) elevation. We aimed to evaluate treatment effects in this patient population.
Methods
This rollover study extended a placebo-controlled trial that enrolled non-cirrhotic patients with CHB and ALT levels below two times the upper limit of normal. Following 3 years of randomized intervention with either tenofovir disoproxil fumarate (TDF) or placebo, participants were rolled over to open-label TDF for 3 years. Liver biopsies were performed before and after the treatment to evaluate histopathological changes. Virological, biochemical, and serological outcomes were also assessed (NCT02463019).
Results
Of 146 enrolled patients (median age 47 years, 80.8% male), 123 completed the study with paired biopsies. Overall, the Ishak fibrosis score decreased in 74 (60.2%), remained unchanged in 32 (26.0%), and increased in 17 (13.8%) patients (p<0.0001). The Knodell necroinflammation score decreased in 58 (47.2%), remained unchanged in 29 (23.6%), and increased in 36 (29.3%) patients (p=0.0038). The proportion of patients with an Ishak score ≥ 3 significantly decreased from 26.8% (n=33) to 9.8% (n=12) (p=0.0002). Histological improvements were more pronounced in patients switching from placebo. Virological and biochemical outcomes also improved in placebo switchers and remained stable in patients who continued TDF. However, serum HBsAg levels did not change and no patient cleared HBsAg.
Conclusions
In CHB patients with minimally raised ALT, favorable histopathological, biochemical, and virological outcomes were observed following 3-year TDF treatment, for both treatment-naïve patients and those already on therapy.
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