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. 2025 Apr;49(4):102566.
doi: 10.1016/j.clinre.2025.102566. Epub 2025 Mar 3.

Long-term virological and clinical evaluation of chronic hepatitis B patients under nucleos(t)ide analogues therapy

Maria Stella Franzè  1 , Carlo Saitta  2 , Daniele Lombardo  3 , Cristina Musolino  3 , Gaia Caccamo  4 , Roberto Filomia  4 , Concetta Pitrone  4 , Irene Cacciola  2 , Teresa Pollicino  3 , Giovanni Raimondo  5
Affiliations

Long-term virological and clinical evaluation of chronic hepatitis B patients under nucleos(t)ide analogues therapy

Maria Stella Franzè et al. Clin Res Hepatol Gastroenterol. 2025 Apr.

Abstract

Introduction and objectives: Identifying hepatitis B virus (HBV) patients eligible for safe nucleos(t)ide analogues (NAs) discontinuation remains challenging. Discrepant data on combined HBV DNA and quantitative HBV surface antigen (qHBsAg) assessments are available. This study aimed to identify potential predictors for safe treatment discontinuation by evaluating clinical/virological outcomes in patients on long-term NA therapy.

Patients and methods: A retrospective cohort of 139 chronic hepatitis B (CHB) patients - who consecutively started Entecavir or Tenofovir from 2007 to 2011 - was evaluated. The study population was selected based on anti-HBe positivity, absence of prior antiviral treatment, absence of non-HBV-related liver diseases or hepatocellular carcinoma (HCC), and long-term clinical/ultrasonographic/laboratory evaluations post-NA initiation. Serum samples collected before starting NA (T0) and over ten years (T1-T10) were tested for HBV DNA and qHBsAg.

Results: Twenty-two/139 (15.8 %) CHB patients (12 chronic hepatitis, 10 cirrhosis) met the inclusion criteria. All patients showed a significant decrease in liver stiffness values in the ten years of follow-up (p = 0.001), and no hepatic decompensation occurred. Three/22 (13.6 %) patients developed HCC. Ten/22 patients (45.5 %; group-A) had fluctuating HBV DNA, while other 10/22 (45.5 %; group-B) showed undetectable HBV DNA for 5-9 years with more significant qHBsAg decline (p = 0.04) than group-A. Two/22 (9.1 %) patients showed a critical qHBsAg decline up to seroconversion together with undetectable HBV DNA.

Conclusions: Persistent undetectable HBV DNA levels correlate with qHBsAg reduction and the potential HBsAg seroclearance, suggesting that long-term HBV DNA monitoring in NA-treated CHB patients might help identify candidates for treatment discontinuation.

Keywords: Chronic hepatitis B; HBV DNA; anti-HBe; quantitative HBsAg.

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Conflict of interest statement

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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