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Volume 36 Issue 2
April 2021
    Citation: Minghui Li, Lu Zhang, Yao Lu, Qiqi Chen, Huihui Lu, Fangfang Sun, Zhan Zeng, Gang Wan, Linqing Zhao, Yao Xie. Early Serum HBsAg Kinetics as Predictor of HBsAg Loss in Patients with HBeAg-Negative Chronic Hepatitis B after Treatment with Pegylated Interferonα-2a .VIROLOGICA SINICA, 2021, 36(2) : 311-320.  http://dx.doi.org/10.1007/s12250-020-00290-7
    shu

    Early Serum HBsAg Kinetics as Predictor of HBsAg Loss in Patients with HBeAg-Negative Chronic Hepatitis B after Treatment with Pegylated Interferonα-2a

    cstr: 32224.14.s12250-020-00290-7
    • 1.

      Department of Hepatology Division 2, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China

    • 2.

      Department of Hepatology Division 2, Peking University Ditan Teaching Hospital, Beijing 100015, China

    • 3.

      Department of Biostatistics, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China

    • 4.

      Laboratory of Virology Capital Institute of Pediatrics, Beijing 100020, China

    • Corresponding author: Linqing Zhao, linqingz525@163.com, ORCID: http://orcid.org/0000-0002-5622-1959
      Yao Xie, xieyao00120184@sina.com, ORCID: http://orcid.org/0000-0002-2330-6497
    • Minghui Li and Lu Zhang have contributed equally to this work.
    • Received Date: 19 January 2020
      Accepted Date: 16 July 2020
      Published Date: 25 September 2020
      Available online: 01 April 2021

    • Hepatitis B surface antigen (HBsAg) loss is an ideal treatment endpoint for patients with chronic hepatitis B (CHB). We investigated the predictive value of on-treatment HBsAg levels for HBsAg loss in hepatitis B e antigen (HBeAg)-negative CHB patients who received 120-week PEG-IFNα-2a treatment. Serum HBV DNA, HBsAg, and anti-HBs levels were assayed at baseline and every 3 months during the treatment. Of 81 patients, 12 achieved HBsAg loss, 20 achieved HBsAg < 100 IU/mL, and 49 maintained HBsAg≥100 IU/mL. HBsAg loss rate was only 3.7% at 48 weeks, while it reached to 11.1% and 14.8% after treatment of 96 weeks and 120 weeks. The cutoff HBsAg levels at 12 weeks predicting HBsAg loss at 96 weeks and 120 weeks of treatment were 400 IU/mL and 750 IU/mL, with AUC 0.725 and 0.722, positive predictive value (PPV) 29.41% and 30.56%, and negative predictive value (NPV) 93.75% and 97.78%, respectively. The cutoff HBsAg levels at 24 weeks predicting HBsAg loss at 96 weeks and 120 weeks of treatment were 174 IU/mL and 236 IU/mL respectively, with AUC 0.925 and 0.922, PPV 40.0% and 46.15%, and both NPV 100%. The predictive ability of the cutoff HBsAg levels at 24 weeks was better than that at 12 weeks for HBsAg loss at either 96 or 120 weeks (χ2=3.880, P=0.049 and χ2=4.412, P=0.036). These results indicate that extended therapy is critical to HBsAg loss in HBeAg-negative CHB patients during PEG-IFN treatment, and the HBsAg level at 24 weeks can be used to predict HBsAg loss during tailoring PEG-IFN therapy.

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      Early Serum HBsAg Kinetics as Predictor of HBsAg Loss in Patients with HBeAg-Negative Chronic Hepatitis B after Treatment with Pegylated Interferonα-2a

        Corresponding author: Linqing Zhao, linqingz525@163.com
        Corresponding author: Yao Xie, xieyao00120184@sina.com
      • 1. Department of Hepatology Division 2, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China
      • 2. Department of Hepatology Division 2, Peking University Ditan Teaching Hospital, Beijing 100015, China
      • 3. Department of Biostatistics, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China
      • 4. Laboratory of Virology Capital Institute of Pediatrics, Beijing 100020, China
      • Received Date: 19 January 2020
      • Accepted Date: 16 July 2020
      • Published Date: 25 September 2020

      Abstract: 

      Hepatitis B surface antigen (HBsAg) loss is an ideal treatment endpoint for patients with chronic hepatitis B (CHB). We investigated the predictive value of on-treatment HBsAg levels for HBsAg loss in hepatitis B e antigen (HBeAg)-negative CHB patients who received 120-week PEG-IFNα-2a treatment. Serum HBV DNA, HBsAg, and anti-HBs levels were assayed at baseline and every 3 months during the treatment. Of 81 patients, 12 achieved HBsAg loss, 20 achieved HBsAg < 100 IU/mL, and 49 maintained HBsAg≥100 IU/mL. HBsAg loss rate was only 3.7% at 48 weeks, while it reached to 11.1% and 14.8% after treatment of 96 weeks and 120 weeks. The cutoff HBsAg levels at 12 weeks predicting HBsAg loss at 96 weeks and 120 weeks of treatment were 400 IU/mL and 750 IU/mL, with AUC 0.725 and 0.722, positive predictive value (PPV) 29.41% and 30.56%, and negative predictive value (NPV) 93.75% and 97.78%, respectively. The cutoff HBsAg levels at 24 weeks predicting HBsAg loss at 96 weeks and 120 weeks of treatment were 174 IU/mL and 236 IU/mL respectively, with AUC 0.925 and 0.922, PPV 40.0% and 46.15%, and both NPV 100%. The predictive ability of the cutoff HBsAg levels at 24 weeks was better than that at 12 weeks for HBsAg loss at either 96 or 120 weeks (χ2=3.880, P=0.049 and χ2=4.412, P=0.036). These results indicate that extended therapy is critical to HBsAg loss in HBeAg-negative CHB patients during PEG-IFN treatment, and the HBsAg level at 24 weeks can be used to predict HBsAg loss during tailoring PEG-IFN therapy.

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