Stopping nucleot(s)ide analogues in non-cirrhotic HBeAg-negative chronic hepatitis B patients : HBsAg loss at 96 weeks is associated with low baseline HBsAg levels
© 2022 John Wiley & Sons Ltd..
BACKGROUND AND AIMS: Current guidelines recommend long-term nucleot(s)ide analogue (NA) therapy for patients with HBeAg-negative chronic hepatitis B (CHB). However, disease remission has been described after stopping NA therapy, as well as HBsAg loss.
METHODS: We performed a prospective multi-centre cohort study of stopping NA therapy. Inclusion criteria were HBeAg-negative CHB, the absence of cirrhosis and HBVDNA<lower limit of quantification for ≥18 months. We assessed virological and biochemical outcomes including HBsAg loss, as well as NA restart rates, over 96 weeks.
RESULTS: In total, 110 patients [62% entecavir (ETV); 28% tenofovir (TDF), 10% other] were enrolled. Median age was 56 years, 57% were male, 85% were Asian, median baseline HBsAg level was 705 (214-2325) IU/ml. Virological reactivation occurred in 109/110 patients, median time to detection was 8 (4-12) weeks, and occurred earlier after stopping TDF versus ETV (median 4 vs. 12 weeks p < 0.001). At week 96, 77 (70%) remained off-treatment, 65 (59%) had ALT <2× ULN, 31 (28%) patients were in disease remission with HBVDNA <2000 IU/ml plus ALT <2× ULN and 7 (6%) patients had lost HBsAg. Baseline HBsAg ≤10 IU/ml was associated with HBsAg loss (6/9 vs. 1/101 p < 0.001). ALT >5× ULN occurred in 35 (32%); ALT flares were not associated with HBsAg loss. There were no unexpected safety issues.
CONCLUSION: Virological reactivation was very common after stopping NA therapy and occurred earlier after stopping TDF versus ETV. The majority of patients had ALT <2× ULN at week 96, but only one-third achieved disease remission and HBsAg loss was rare. Very low HBsAg levels at baseline were uncommon but predicted for HBsAg loss and disease remission.
| Errataetall: |
CommentIn: Aliment Pharmacol Ther. 2022 Aug;56(3):544-545. - PMID 35804472 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:56 |
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| Enthalten in: |
Alimentary pharmacology & therapeutics - 56(2022), 2 vom: 17. Juli, Seite 310-320 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Hall, Samuel A L [VerfasserIn] |
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| Links: |
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| Themen: |
Antiviral Agents |
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| Anmerkungen: |
Date Completed 28.06.2022 Date Revised 29.01.2023 published: Print-Electronic CommentIn: Aliment Pharmacol Ther. 2022 Aug;56(3):544-545. - PMID 35804472 Citation Status MEDLINE |
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| doi: |
10.1111/apt.16968 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM340505265 |
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| 100 | 1 | |a Hall, Samuel A L |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Stopping nucleot(s)ide analogues in non-cirrhotic HBeAg-negative chronic hepatitis B patients |b HBsAg loss at 96 weeks is associated with low baseline HBsAg levels |
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| 500 | |a Date Revised 29.01.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a CommentIn: Aliment Pharmacol Ther. 2022 Aug;56(3):544-545. - PMID 35804472 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2022 John Wiley & Sons Ltd. | ||
| 520 | |a BACKGROUND AND AIMS: Current guidelines recommend long-term nucleot(s)ide analogue (NA) therapy for patients with HBeAg-negative chronic hepatitis B (CHB). However, disease remission has been described after stopping NA therapy, as well as HBsAg loss | ||
| 520 | |a METHODS: We performed a prospective multi-centre cohort study of stopping NA therapy. Inclusion criteria were HBeAg-negative CHB, the absence of cirrhosis and HBVDNA<lower limit of quantification for ≥18 months. We assessed virological and biochemical outcomes including HBsAg loss, as well as NA restart rates, over 96 weeks | ||
| 520 | |a RESULTS: In total, 110 patients [62% entecavir (ETV); 28% tenofovir (TDF), 10% other] were enrolled. Median age was 56 years, 57% were male, 85% were Asian, median baseline HBsAg level was 705 (214-2325) IU/ml. Virological reactivation occurred in 109/110 patients, median time to detection was 8 (4-12) weeks, and occurred earlier after stopping TDF versus ETV (median 4 vs. 12 weeks p < 0.001). At week 96, 77 (70%) remained off-treatment, 65 (59%) had ALT <2× ULN, 31 (28%) patients were in disease remission with HBVDNA <2000 IU/ml plus ALT <2× ULN and 7 (6%) patients had lost HBsAg. Baseline HBsAg ≤10 IU/ml was associated with HBsAg loss (6/9 vs. 1/101 p < 0.001). ALT >5× ULN occurred in 35 (32%); ALT flares were not associated with HBsAg loss. There were no unexpected safety issues | ||
| 520 | |a CONCLUSION: Virological reactivation was very common after stopping NA therapy and occurred earlier after stopping TDF versus ETV. The majority of patients had ALT <2× ULN at week 96, but only one-third achieved disease remission and HBsAg loss was rare. Very low HBsAg levels at baseline were uncommon but predicted for HBsAg loss and disease remission | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Antiviral Agents |2 NLM | |
| 650 | 7 | |a DNA, Viral |2 NLM | |
| 650 | 7 | |a Hepatitis B Surface Antigens |2 NLM | |
| 650 | 7 | |a Hepatitis B e Antigens |2 NLM | |
| 700 | 1 | |a Burns, Gareth S |e verfasserin |4 aut | |
| 700 | 1 | |a Anagnostou, Despina |e verfasserin |4 aut | |
| 700 | 1 | |a Vogrin, Sara |e verfasserin |4 aut | |
| 700 | 1 | |a Sundararajan, Vijaya |e verfasserin |4 aut | |
| 700 | 1 | |a Ratnam, Dilip |e verfasserin |4 aut | |
| 700 | 1 | |a Levy, Miriam T |e verfasserin |4 aut | |
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| 700 | 1 | |a Meredith, Christopher |e verfasserin |4 aut | |
| 700 | 1 | |a Matthews, Gail |e verfasserin |4 aut | |
| 700 | 1 | |a Revill, Peter A |e verfasserin |4 aut | |
| 700 | 1 | |a Jackson, Kathy |e verfasserin |4 aut | |
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| 700 | 1 | |a Locarnini, Stephen A |e verfasserin |4 aut | |
| 700 | 1 | |a Visvanathan, Kumar |e verfasserin |4 aut | |
| 700 | 1 | |a Thompson, Alexander J |e verfasserin |4 aut | |
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