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Background <p>This multicenter study evaluated serum HBV RNA as a prognostic biomarker for nucleos(t)ide analogue (NA) therapy in chronic hepatitis B (CHB), focusing on correlations with HBV DNA/HBsAg and predictive value for virological response (VR) and HBeAg seroconversion.</p> Methods <p>From 2020 to 2024, 427 treatment-naive HBeAg-positive CHB patients across nine Chinese hospitals were enrolled. Longitudinal HBV RNA-DNA-HBsAg correlations were analyzed during 24-month NA therapy. Predictive performance for VR at 12 months and HBeAg seroconversion at 24 months was assessed.</p> Results <p>Non-VR patients had higher baseline HBV DNA (median 7.42 vs. 5.38 log<sub>10</sub> IU/mL, <i>P</i> = 0.001) and HBV RNA (6.63 vs. 4.60 log<sub>10</sub> copies/mL, <i>P</i> = 0.001). Pretreatment HBV RNA correlated with HBV DNA (<i>r</i> = 0.638, <i>P</i> = 0.001), shifting to HBsAg post-24-month treatment (<i>r</i> = 0.917, <i>P</i> = 0.0005). HBV DNA and RNA levels at 6 months independently predicted therapeutic outcomes. For VR, HBV DNA demonstrated a hazard ratio (HR) of 0.16 (<i>P</i> &lt; 0.001) with an area under the ROC curve (AUROC) of 0.889, while HBV RNA showed an HR of 0.77 (<i>P</i> = 0.03) and AUROC of 0.754. For HBeAg seroconversion, HBV DNA yielded an HR of 0.01 (<i>P</i> = 0.015) with AUROC 0.900, and HBV RNA exhibited an HR of 0.72 (<i>P</i> = 0.03) and AUROC 0.703, underscoring their consistent prognostic value at this critical timepoint.</p> Conclusions <p>HBV RNA dynamics transition from DNA- to HBsAg-associated correlations during NA therapy. Early declines in HBV DNA/RNA at 6 months predict VR and HBeAg seroconversion, establishing this time as a a robust and clinically practical early prediction point. HBV RNA complements existing biomarkers for optimizing CHB management.</p>

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HBV RNA at 6 months after nucleos(t)ide analogues treatment can predict antiviral efficacy in chronic hepatitis B patients

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月2日

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  • Yandi Xie,
  • Xiaojing Zhang,
  • Xiaozhou Yang,
  • Sujun Zheng,
  • Shuyun Zhang,
  • Xiaoying Zhang,
  • Haiyan Kang,
  • Xuefei Duan,
  • Wenpin Cai,
  • Peng Yin,
  • Xinghuan Ma,
  • Juan liu,
  • Fengmin Lu,
  • Lizhong Dai,
  • Bo Feng

摘要

Background

This multicenter study evaluated serum HBV RNA as a prognostic biomarker for nucleos(t)ide analogue (NA) therapy in chronic hepatitis B (CHB), focusing on correlations with HBV DNA/HBsAg and predictive value for virological response (VR) and HBeAg seroconversion.

Methods

From 2020 to 2024, 427 treatment-naive HBeAg-positive CHB patients across nine Chinese hospitals were enrolled. Longitudinal HBV RNA-DNA-HBsAg correlations were analyzed during 24-month NA therapy. Predictive performance for VR at 12 months and HBeAg seroconversion at 24 months was assessed.

Results

Non-VR patients had higher baseline HBV DNA (median 7.42 vs. 5.38 log10 IU/mL, P = 0.001) and HBV RNA (6.63 vs. 4.60 log10 copies/mL, P = 0.001). Pretreatment HBV RNA correlated with HBV DNA (r = 0.638, P = 0.001), shifting to HBsAg post-24-month treatment (r = 0.917, P = 0.0005). HBV DNA and RNA levels at 6 months independently predicted therapeutic outcomes. For VR, HBV DNA demonstrated a hazard ratio (HR) of 0.16 (P < 0.001) with an area under the ROC curve (AUROC) of 0.889, while HBV RNA showed an HR of 0.77 (P = 0.03) and AUROC of 0.754. For HBeAg seroconversion, HBV DNA yielded an HR of 0.01 (P = 0.015) with AUROC 0.900, and HBV RNA exhibited an HR of 0.72 (P = 0.03) and AUROC 0.703, underscoring their consistent prognostic value at this critical timepoint.

Conclusions

HBV RNA dynamics transition from DNA- to HBsAg-associated correlations during NA therapy. Early declines in HBV DNA/RNA at 6 months predict VR and HBeAg seroconversion, establishing this time as a a robust and clinically practical early prediction point. HBV RNA complements existing biomarkers for optimizing CHB management.