Prediction of Sustained Response After Nucleo(s)tide Analogue Cessation Using HBsAg and HBcrAg Levels : A Multicenter Study (CREATE)
Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved..
BACKGROUND & AIMS: Predictors of successful nucleo(s)tide analogue (NA) therapy withdrawal remain elusive. We studied the relationship between end-of-treatment levels of hepatitis B core-related antigen (HBcrAg) and hepatitis B surface antigen (HBsAg) and outcome after therapy cessation.
METHODS: Patients who discontinued NA therapy in centers in Asia and Europe were enrolled. HBcrAg and HBsAg were measured at treatment cessation, and associations with off-treatment outcomes were explored. The SCALE-B (Surface antigen, Core-related antigen, Age, ALT, and tenofovir for HBV) score was calculated as previously reported. End points included sustained virologic response (VR; hepatitis B virus DNA level <2000 IU/mL), HBsAg loss, and alanine aminotransferase (ALT) flares (>3× upper limit of normal). Re-treated patients were considered nonresponders.
RESULTS: We analyzed 572 patients, 457 (80%) were Asian and 95 (17%) were hepatitis B e antigen positive at the start of NA therapy. The median treatment duration was 295 weeks. VR was observed in 267 (47%), HBsAg loss was observed in 24 (4.2%), and ALT flare was observed in 92 (16%). VR (67% vs 42%) and HBsAg loss (15% vs 1.5%) was observed more frequently in non-Asian patients when compared to Asian patients (P < .001). Lower HBcrAg levels were associated with higher rates of VR (odds ratio [OR], 0.701; P < .001) and HBsAg loss (OR, 0.476; P < .001), and lower rates of ALT flares (OR, 1.288; P = .005). Similar results were observed with HBsAg (VR: OR, 0.812; P = .011; HBsAg loss: OR, 0.380; P < .001; and ALT flare: OR, 1.833; P < .001). Lower SCALE-B scores were associated with higher rates of VR, HBsAg loss, and lower rates of ALT flares in both Asian and non-Asian patients (P < .001).
CONCLUSIONS: In this multicenter study, off-treatment outcomes after NA cessation varied with ethnicity. Lower levels of HBcrAg and HBsAg were associated with favorable outcomes. A risk score comprising both factors can be used for risk stratification.
| Errataetall: |
CommentIn: Clin Gastroenterol Hepatol. 2021 Dec;19(12):2680-2681. - PMID 33387671 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:20 |
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| Enthalten in: |
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association - 20(2022), 4 vom: 01. Apr., Seite e784-e793 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Sonneveld, Milan J [VerfasserIn] |
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| Links: |
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| Themen: |
Antiviral Agents |
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| Anmerkungen: |
Date Completed 16.03.2022 Date Revised 16.03.2022 published: Print-Electronic CommentIn: Clin Gastroenterol Hepatol. 2021 Dec;19(12):2680-2681. - PMID 33387671 Citation Status MEDLINE |
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| doi: |
10.1016/j.cgh.2020.12.005 |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM31875102X |
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| 245 | 1 | 0 | |a Prediction of Sustained Response After Nucleo(s)tide Analogue Cessation Using HBsAg and HBcrAg Levels |b A Multicenter Study (CREATE) |
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| 500 | |a Date Revised 16.03.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a CommentIn: Clin Gastroenterol Hepatol. 2021 Dec;19(12):2680-2681. - PMID 33387671 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND & AIMS: Predictors of successful nucleo(s)tide analogue (NA) therapy withdrawal remain elusive. We studied the relationship between end-of-treatment levels of hepatitis B core-related antigen (HBcrAg) and hepatitis B surface antigen (HBsAg) and outcome after therapy cessation | ||
| 520 | |a METHODS: Patients who discontinued NA therapy in centers in Asia and Europe were enrolled. HBcrAg and HBsAg were measured at treatment cessation, and associations with off-treatment outcomes were explored. The SCALE-B (Surface antigen, Core-related antigen, Age, ALT, and tenofovir for HBV) score was calculated as previously reported. End points included sustained virologic response (VR; hepatitis B virus DNA level <2000 IU/mL), HBsAg loss, and alanine aminotransferase (ALT) flares (>3× upper limit of normal). Re-treated patients were considered nonresponders | ||
| 520 | |a RESULTS: We analyzed 572 patients, 457 (80%) were Asian and 95 (17%) were hepatitis B e antigen positive at the start of NA therapy. The median treatment duration was 295 weeks. VR was observed in 267 (47%), HBsAg loss was observed in 24 (4.2%), and ALT flare was observed in 92 (16%). VR (67% vs 42%) and HBsAg loss (15% vs 1.5%) was observed more frequently in non-Asian patients when compared to Asian patients (P < .001). Lower HBcrAg levels were associated with higher rates of VR (odds ratio [OR], 0.701; P < .001) and HBsAg loss (OR, 0.476; P < .001), and lower rates of ALT flares (OR, 1.288; P = .005). Similar results were observed with HBsAg (VR: OR, 0.812; P = .011; HBsAg loss: OR, 0.380; P < .001; and ALT flare: OR, 1.833; P < .001). Lower SCALE-B scores were associated with higher rates of VR, HBsAg loss, and lower rates of ALT flares in both Asian and non-Asian patients (P < .001) | ||
| 520 | |a CONCLUSIONS: In this multicenter study, off-treatment outcomes after NA cessation varied with ethnicity. Lower levels of HBcrAg and HBsAg were associated with favorable outcomes. A risk score comprising both factors can be used for risk stratification | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
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| 650 | 4 | |a Sustained Response | |
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| 650 | 7 | |a Hepatitis B Core Antigens |2 NLM | |
| 650 | 7 | |a Hepatitis B Surface Antigens |2 NLM | |
| 700 | 1 | |a Park, Jun Yong |e verfasserin |4 aut | |
| 700 | 1 | |a Kaewdech, Apichat |e verfasserin |4 aut | |
| 700 | 1 | |a Seto, Wai-Kay |e verfasserin |4 aut | |
| 700 | 1 | |a Tanaka, Yasuhito |e verfasserin |4 aut | |
| 700 | 1 | |a Carey, Ivana |e verfasserin |4 aut | |
| 700 | 1 | |a Papatheodoridi, Margarita |e verfasserin |4 aut | |
| 700 | 1 | |a van Bömmel, Florian |e verfasserin |4 aut | |
| 700 | 1 | |a Berg, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Zoulim, Fabien |e verfasserin |4 aut | |
| 700 | 1 | |a Ahn, Sang Hoon |e verfasserin |4 aut | |
| 700 | 1 | |a Dalekos, George N |e verfasserin |4 aut | |
| 700 | 1 | |a Erler, Nicole S |e verfasserin |4 aut | |
| 700 | 1 | |a Höner Zu Siederdissen, Christoph |e verfasserin |4 aut | |
| 700 | 1 | |a Wedemeyer, Heiner |e verfasserin |4 aut | |
| 700 | 1 | |a Cornberg, Markus |e verfasserin |4 aut | |
| 700 | 1 | |a Yuen, Man-Fung |e verfasserin |4 aut | |
| 700 | 1 | |a Agarwal, Kosh |e verfasserin |4 aut | |
| 700 | 1 | |a Boonstra, Andre |e verfasserin |4 aut | |
| 700 | 1 | |a Buti, Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Piratvisuth, Teerha |e verfasserin |4 aut | |
| 700 | 1 | |a Papatheodoridis, George |e verfasserin |4 aut | |
| 700 | 1 | |a Maasoumy, Benjamin |e verfasserin |4 aut | |
| 700 | 0 | |a CREATE Study Group |e verfasserin |4 aut | |
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