Expanding treatment eligibility for chronic hepatitis B: Balancing benefits, limitations, and healthcare access: Correspondence to editorial on “Antiviral therapy for chronic hepatitis B with mildly elevated aminotransferase: A rollover study from the TOR Yao-Chun Hsu, Chi-Yi Chen, Jaw-Town Lin Clinical and Molecular Hepatology.2025; 31(2): e169. CrossRef
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).
Result s: 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.
Tenofovir Disoproxil Fumarate Versus Entecavir: Effects on Lipid Profiles and Cardiovascular Outcomes in People Living With Chronic Hepatitis B Log Young Kim, Jae Young Kim, Jeong‐Ju Yoo, Sang Gyune Kim, Young‐Seok Kim Journal of Medical Virology.2025;[Epub] CrossRef
Safety of tenofovir alafenamide in the context of hyperlipidemia and cardiovascular diseases: a nationwide analysis Jae-Young Kim, Hyuk Kim, Jeong-Ju Yoo, Sang Gyune Kim, Young-Seok Kim Hepatology International.2025; 19(4): 959. CrossRef
Long-Term Safety and Efficacy of Tenofovir Alafenamide in Chronic Hepatitis B: Raising the Need for Studies on Functional Cure—Editorial on “Long-Term Real-World Outcomes of Tenofovir Alafenamide in Chronic Hepatitis B” Soon Kyu Lee The Korean Journal of Gastroenterology.2025; 85(3): 245. CrossRef
Risk of dyslipidaemia in people living with HIV who are taking tenofovir alafenamide: a systematic review and meta‐analysis Jeong‐Ju Yoo, Eun Ae Jung, Sang Gyune Kim, Young Seok Kim, Min Jae Kim Journal of the International AIDS Society.2024;[Epub] CrossRef
Tenofovir Alafenamide for Multiple Drug-Resistant Chronic Hepatitis B: A 3-Year Clinical Trial Jonggi Choi, Young-Suk Lim, Ji-Hoon Kim, Kwan Soo Byun, Byung Chul Yoo Clinical Gastroenterology and Hepatology.2023; 21(12): 3185. CrossRef
Risk of dyslipidemia in chronic hepatitis B patients taking tenofovir alafenamide: a systematic review and meta-analysis Eui Gwon Hwang, Eun-Ae Jung, Jeong-Ju Yoo, Sang Gyune Kim, Young Seok Kim Hepatology International.2023; 17(4): 860. CrossRef
Are the New Nucleos(t)ide Analogs Better than the Old Nucleos(t)ide Analogs? Jonggi Choi, Won-Mook Choi, Young-Suk Lim Clinics in Liver Disease.2023; 27(4): 809. CrossRef
First
Prev
