Baseline and early on-treatment HBsAg level to predict HBsAg loss in nucleotide analog suppressed and HBeAg cleared chronic hepatitis B patients by switching to peginterferon alfa-2a: exploratory results of NEW SWITCH study

Abstract Background: For chronic hepatitis B (CHB) patients without willingness to extend the routine duration of interferon (IFN) therapy, it is important to identify patients who will benefit from treatment cessation. Hepatitis B surface antigen (HBsAg) quantification is recommended for management of IFN therapy. At present, the understanding on end-of-treatment (EOT) HBsAg level predicting post-treatment response to IFN is still finite. Methods: Patients with CHB infection and treated with IFN-based therapy during the period from December 2010 to December 2017 at Nanfang Hospital were enrolled in this study. Serum HBsAg levels at EOT were measured to evaluate the associations between EOT HBsAg levels (Group 1, HBsAg >0.05 and ≤10 IU/mL; Group 2, HBsAg >10 and ≤200 IU/mL; Group 3, HBsAg >200 IU/mL) with post-treatment HBsAg loss. Chi-squared, t-test, ,Kaplan-Meier analysis, Cox regression analysis, and Multivariate Logistic regression analysis were used to analyse and evaluate differences between the there groups. Results: The cumulative HBsAg loss rates 5 years after treatment in Group 1-3 were 30.4% (17/56), 9.8%(4/41) and 0%(0/153) (p<0.001). An EOT HBsAg level of >10 IU/mL showed relatively high negative predictive value (NPV) of up to 97.9% for HBsAg loss. Low baseline HBsAg level <25000 IU/mL, on-treatment HBsAg decline >1 log10IU/mL at week 24 and EOT HBsAg level ≤10 IU/mL were found significantly associated with HBsAg loss. A total of 6 patients have achieved HBsAg loss at EOT and 17 patients with EOT HBsAg level ≤10 IU/mL have achieved post-treatment HBsAg loss. Baseline characteristics, dynamic changes of on-treatment HBsAg and duration of IFN therapy were balanced across patients with EOT or post-treatment HBsAg loss. Conclusion: EOT HBsAg level can serve as a monitoring indicator for IFN therapy. EOT HBsAg level ≤10 IU/mL was found to lead to high rate of post-treatment HBsAg loss. For patients without willingness to extend IFN treatment, off-treatment follow-up could be considered when HBsAg level decreased to ≤10 IU/mL.

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Baseline hepatitis B surface antigen (HBsAg) as predictor of sustained HBsAg loss in chronic hepatitis B patients treated with peginterferon alfa-2a and adefovir

Antiviral Therapy ◽

10.3851/imp2580 ◽

2013 ◽

Vol 18 (7) ◽

pp. 895-904 ◽

Cited By ~ 44

Author(s):

R Bart Takkenberg ◽

Louis Jansen ◽

Annikki de Niet ◽

Hans L Zaaijer ◽

Christine J Weegink ◽

...

Keyword(s):

Chronic Hepatitis ◽

Hepatitis B ◽

Chronic Hepatitis B ◽

Surface Antigen ◽

Hepatitis B Surface Antigen ◽

Hbsag Loss ◽

Peginterferon Alfa

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Early serum HBsAg level as a strong predictor of sustained response to peginterferon alfa-2a in HBeAg-negative chronic hepatitis B

Alimentary Pharmacology & Therapeutics ◽

10.1111/j.1365-2036.2011.04973.x ◽

2012 ◽

Vol 35 (4) ◽

pp. 458-468 ◽

Cited By ~ 32

Author(s):

C.-Y. Peng ◽

H.-C. Lai ◽

Y.-F. Li ◽

W.-P. Su ◽

P.-H. Chuang ◽

...

Keyword(s):

Chronic Hepatitis ◽

Hepatitis B ◽

Chronic Hepatitis B ◽

Strong Predictor ◽

Sustained Response ◽

Hbsag Level ◽

Serum Hbsag ◽

Peginterferon Alfa ◽

Serum Hbsag Level ◽

Negative Chronic Hepatitis

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A Simple-to-use Tool for Predicting Response to Peginterferon in HBV DNA Suppressed Chronic Hepatitis B Patients

10.21203/rs.3.rs-255805/v1 ◽

2021 ◽

Author(s):

Peipei Ren ◽

Hu Li ◽

Yan Huang ◽

Jiayuan Jiang ◽

Simin Guo ◽

...

Keyword(s):

Chronic Hepatitis ◽

Hepatitis B ◽

Chronic Hepatitis B ◽

Scoring System ◽

Validation Cohort ◽

Operating Characteristics ◽

Hbsag Level ◽

Training Cohort ◽

Hbsag Loss ◽

End Of Treatment

Abstract Background: Rational administration of peginterferon can remarkably reduce serum HBsAg level and improve the rate of HBsAg loss. Considering the high cost and low tolerability of peginterferon, we aimed to develop a simple-to-use scoring system at early stage of treatment to predict low HBsAg level or HBsAg loss at the end of treatment in virological suppressed chronic hepatitis B (CHB) patients.Methods: Non-cirrhotic CHB patients with NA (nucleoside/nucleotide analogues)-induced virological suppression initiated peginterferon treatment by either add-on or switch-to strategy for 48 weeks were enrolled from January 2012 to June 2017 in two tertiary centers. The retrospective design enrolled 320 subjects, including 189 patients in the training cohort and 131 patients in the validation cohort.Results: By logistic regression, a simple-to-use scoring system integrating baseline HBsAg level < 1000 IU/mL, HBsAg decline > 0.5 log at week 12 and ALT flare at week 12 was developed in the training cohort and high performance for predicting HBsAg < 100 IU/mL, HBsAg < 10 IU/mL and HBsAg loss at the end of 48-week treatment. The area under receiver operating characteristics curve was 0.84, 0.80 and 0.76 in the training cohort and 0.88, 0.87 and 0.84 in the validation cohort, respectively.Conclusions: Our simple-to-use scoring system can guide clinicians to decide whether to continue peginterferon treatment in CHB patients in order to achieve low HBsAg levels or HBsAg loss at the end of treatment, which might greatly improve the opportunity to reach a functional cure in these patients and lead more cost-effective treatment decision.

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Seroreversion and Acute Decompensation in Chronic Hepatitis B after Discontinuation of Oral Nucleotide Analog in the Patients Achieving HBsAg Loss

Korean Journal of Gastroenterology ◽

10.4166/kjg.2020.111 ◽

2020 ◽

Vol 76 (5) ◽

pp. 256-260

Author(s):

Hye Jeong Cho ◽

Seung Kak Shin ◽

Oh Sang Kwon ◽

Ju Hyun Kim ◽

Yun Soo Kim

Keyword(s):

Chronic Hepatitis ◽

Hepatitis B ◽

Chronic Hepatitis B ◽

Nucleotide Analog ◽

Hbsag Loss ◽

Acute Decompensation

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HBsAg quantification predicts off-treatment response to interferon in chronic hepatitis B patients：A retrospective study of 250 cases

10.21203/rs.2.12108/v2 ◽

2020 ◽

Author(s):

Shuai Wu ◽

Wenfan Luo ◽

Yin Wu ◽

Hongjie Chen ◽

Jie Peng

Keyword(s):

Regression Analysis ◽

Chronic Hepatitis ◽

Hepatitis B ◽

Treatment Response ◽

Chronic Hepatitis B ◽

Post Treatment ◽

Hbsag Level ◽

Hbsag Loss ◽

Ifn Therapy ◽

Group 1

Abstract Background: For chronic hepatitis B (CHB) patients without willingness to extend the routine duration of interferon (IFN) therapy, it is important to identify patients who will benefit from treatment cessation. Hepatitis B surface antigen (HBsAg) quantification is recommended for management of IFN therapy. At present, the understanding on end-of-treatment (EOT) HBsAg level predicting post-treatment response to IFN is still finite. Methods: Patients with CHB infection and treated with IFN-based therapy during the period from December 2010 to December 2017 at Nanfang Hospital were enrolled in this study. Serum HBsAg levels at EOT were measured to evaluate the associations between EOT HBsAg levels (Group 1, HBsAg >0.05 and ≤10 IU/mL; Group 2, HBsAg >10 and ≤200 IU/mL; Group 3, HBsAg >200 IU/mL) with post-treatment HBsAg loss. Chi-squared, t-test, ,Kaplan-Meier analysis, Cox regression analysis, and Multivariate Logistic regression analysis were used to analyse and evaluate differences between the there groups. Results: The cumulative HBsAg loss rates 5 years after treatment in Group 1-3 were 30.4% (17/56), 9.8%(4/41) and 0%(0/153) (p<0.001). An EOT HBsAg level of >10 IU/mL showed relatively high negative predictive value (NPV) of up to 97.9% for HBsAg loss. Low baseline HBsAg level <25000 IU/mL, on-treatment HBsAg decline >1 log10IU/mL at week 24 and EOT HBsAg level ≤10 IU/mL were found significantly associated with HBsAg loss. A total of 6 patients have achieved HBsAg loss at EOT and 17 patients with EOT HBsAg level ≤10 IU/mL have achieved post-treatment HBsAg loss. Baseline characteristics, dynamic changes of on-treatment HBsAg and duration of IFN therapy were balanced across patients with EOT or post-treatment HBsAg loss. Conclusion: EOT HBsAg level can serve as a monitoring indicator for IFN therapy. EOT HBsAg level ≤10 IU/mL was found to lead to high rate of post-treatment HBsAg loss. For patients without willingness to extend IFN treatment, off-treatment follow-up could be considered when HBsAg level decreased to ≤10 IU/mL.

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