Clinical trial: An open-label, randomised trial of different re-start strategies after treatment withdrawal in HBeAg negative chronic hepatitis B
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Clinical trial : An open-label, randomised trial of different re-start strategies after treatment withdrawal in HBeAg negative chronic hepatitis B. / Johannessen, Asgeir; Reikvam, Dag Henrik; Aleman, Soo; Berhe, Nega; Weis, Nina; Desalegn, Hailemichael; Stenstad, Tore; Heggelund, Lars; Samuelsen, Ellen; Karlsen, Lars Normann; Lindahl, Karin; Pettersen, Frank Olav; Iversen, Jonas; Kleppa, Elisabeth; Bollerup, Signe; Winckelmann, Anni Assing; Brugger-Synnes, Pascal; Simonsen, Hans Erling; Svendsen, Jan; Kran, Anne Marte Bakken; Holmberg, Marte; Olsen, Inge Christoffer; Rueegg, Corina Silvia; Dalgard, Olav.
In: Alimentary Pharmacology and Therapeutics, 2024.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Clinical trial
T2 - An open-label, randomised trial of different re-start strategies after treatment withdrawal in HBeAg negative chronic hepatitis B
AU - Johannessen, Asgeir
AU - Reikvam, Dag Henrik
AU - Aleman, Soo
AU - Berhe, Nega
AU - Weis, Nina
AU - Desalegn, Hailemichael
AU - Stenstad, Tore
AU - Heggelund, Lars
AU - Samuelsen, Ellen
AU - Karlsen, Lars Normann
AU - Lindahl, Karin
AU - Pettersen, Frank Olav
AU - Iversen, Jonas
AU - Kleppa, Elisabeth
AU - Bollerup, Signe
AU - Winckelmann, Anni Assing
AU - Brugger-Synnes, Pascal
AU - Simonsen, Hans Erling
AU - Svendsen, Jan
AU - Kran, Anne Marte Bakken
AU - Holmberg, Marte
AU - Olsen, Inge Christoffer
AU - Rueegg, Corina Silvia
AU - Dalgard, Olav
N1 - Publisher Copyright: © 2024 The Author(s). Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.
PY - 2024
Y1 - 2024
N2 - Background: Stopping nucleos(t)ide analogue (NA) therapy in patients with chronic hepatitis B (CHB) may trigger a beneficial immune response leading to HBsAg loss, but clinical trials on re-start strategies are lacking. Aim: To assess whether it is beneficial to undergo a prolonged flare after NA cessation. Methods: One-hundred-and-twenty-seven patients with HBeAg negative, non-cirrhotic CHB with at least 24 months of viral suppression on NA therapy were included. All study participants stopped antiviral therapy and were randomised to either low-threshold (ALT > 80 U/L and HBV DNA > 2000 IU/mL) or high-threshold (ALT > 100 U/L for >4 months, or ALT > 400 U/L for >2 months) for the re-start of therapy. The primary endpoint was HBsAg loss within 36 months of stopping antiviral treatment. The primary analysis was based on intention-to-treat allocation with last observation carried forward. Results: There was a numerical but not statistically significant difference in HBsAg loss between the low-threshold (3 of 64; 4.7%) and the high-threshold (8 of 63; 12.7%) group (risk difference: 8.0%, 95% CI: −2.3 to 19.6, p = 0.123). None of the patients with end-of-treatment HBsAg > 1000 IU/mL achieved HBsAg loss; among those with end-of-treatment HBsAg < 1000 IU/mL, 8 of 15 (53.3%) achieved HBsAg loss in the high-threshold group compared to 3 of 26 (11.5%) in the low-threshold group. Conclusions: We could not confirm our hypothesis that a higher threshold for restart of therapy after NA withdrawal improves the likelihood of HBsAg loss within 36 months in patients with HBeAg negative CHB. Further studies including only patients with HBsAg level <1000 IU/mL and/or larger sample size and longer follow-up duration are recommended.
AB - Background: Stopping nucleos(t)ide analogue (NA) therapy in patients with chronic hepatitis B (CHB) may trigger a beneficial immune response leading to HBsAg loss, but clinical trials on re-start strategies are lacking. Aim: To assess whether it is beneficial to undergo a prolonged flare after NA cessation. Methods: One-hundred-and-twenty-seven patients with HBeAg negative, non-cirrhotic CHB with at least 24 months of viral suppression on NA therapy were included. All study participants stopped antiviral therapy and were randomised to either low-threshold (ALT > 80 U/L and HBV DNA > 2000 IU/mL) or high-threshold (ALT > 100 U/L for >4 months, or ALT > 400 U/L for >2 months) for the re-start of therapy. The primary endpoint was HBsAg loss within 36 months of stopping antiviral treatment. The primary analysis was based on intention-to-treat allocation with last observation carried forward. Results: There was a numerical but not statistically significant difference in HBsAg loss between the low-threshold (3 of 64; 4.7%) and the high-threshold (8 of 63; 12.7%) group (risk difference: 8.0%, 95% CI: −2.3 to 19.6, p = 0.123). None of the patients with end-of-treatment HBsAg > 1000 IU/mL achieved HBsAg loss; among those with end-of-treatment HBsAg < 1000 IU/mL, 8 of 15 (53.3%) achieved HBsAg loss in the high-threshold group compared to 3 of 26 (11.5%) in the low-threshold group. Conclusions: We could not confirm our hypothesis that a higher threshold for restart of therapy after NA withdrawal improves the likelihood of HBsAg loss within 36 months in patients with HBeAg negative CHB. Further studies including only patients with HBsAg level <1000 IU/mL and/or larger sample size and longer follow-up duration are recommended.
U2 - 10.1111/apt.18147
DO - 10.1111/apt.18147
M3 - Journal article
C2 - 38970293
AN - SCOPUS:85197711198
JO - Alimentary Pharmacology and Therapeutics, Supplement
JF - Alimentary Pharmacology and Therapeutics, Supplement
SN - 0953-0673
ER -
ID: 398640770