{"id":82942,"date":"2026-06-24T16:27:41","date_gmt":"2026-06-24T14:27:41","guid":{"rendered":"https:\/\/cri1149.fr\/publication\/no-impact-of-low-dose-nivolumab-addition-to-jnj-73763989-on-hbsag-declines-in-chronic-hepatitis-b-the-octopus-1-study\/"},"modified":"2026-06-24T17:03:06","modified_gmt":"2026-06-24T15:03:06","slug":"no-impact-of-low-dose-nivolumab-addition-to-jnj-73763989-on-hbsag-declines-in-chronic-hepatitis-b-the-octopus-1-study","status":"publish","type":"publication","link":"https:\/\/cri1149.fr\/en\/publication\/no-impact-of-low-dose-nivolumab-addition-to-jnj-73763989-on-hbsag-declines-in-chronic-hepatitis-b-the-octopus-1-study\/","title":{"rendered":"No impact of low-dose nivolumab addition to JNJ-73763989 on HBsAg declines in chronic hepatitis B: the OCTOPUS-1 study"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">Abstract<\/h2>\n\n\n\n<p><strong>Background &amp; aims:&nbsp;<\/strong>JNJ-73763989 (JNJ-3989)-based treatments (evaluations ongoing) reduce HBsAg in chronic hepatitis B (CHB) patients, but HBsAg seroclearance is rare. OCTOPUS-1, an open-label, randomized phase 2 study, assessed the efficacy and safety of adding low-dose nivolumab (PD-1 inhibitor) to JNJ-3989+nucleos(t)ide analog (NA).<\/p>\n\n\n\n<p><strong>Methods:&nbsp;<\/strong>HBeAg-negative, virologically suppressed CHB participants received JNJ-3989 loading dose (200mg once weekly) for 4 weeks then every 4 weeks (Q4W) until Week 24 (W24) with daily NA. Nivolumab (0.3mg\/kg) was administered at W16 for Arm 1 and at W16, W20, and W24 for Arm 2; both arms had 48-week follow-ups (FUW48).<\/p>\n\n\n\n<p><strong>Results:&nbsp;<\/strong>Thirty-seven participants were enrolled (Arm 1: 18; Arm 2: 19); all completed the study. None achieved the primary endpoint of HBsAg seroclearance at FUW24, but 1 (Arm 2) achieved HBsAg seroclearance at FUW48. Both arms had robust mean [SE] HBsAg changes from baseline before nivolumab administration (Arm 1: -1.32[0.12]; Arm 2: -1.41[0.16]log<sub>10<\/sub>IU\/mL), at W24 (Arm 1: -2.01[0.09]; Arm 2: -2.10[0.13]log<sub>10<\/sub>IU\/mL), and at FUW48 (Arm 1: -1.23[0.13]; Arm 2: -1.54[0.21]log<sub>10<\/sub>IU\/mL). The mean receptor occupancy (determined 2 hours post-infusion at W16) was \u226570% and \u226590% in Arms 1 and 2 with no clear association between HBV-specific T-cells and HBsAg. No serious adverse events (AEs), grade 3\/4 AEs, or AEs leading to discontinuation were reported; 2 participants experienced asymptomatic transient hyperthyroidism. Cross-study analysis with REEF-1 (virologically suppressed, HBeAg-negative participants) revealed no additional benefit of loading dose or nivolumab.<\/p>\n\n\n\n<p><strong>Conclusions:&nbsp;<\/strong>JNJ-3989+NA+nivolumab treatment was generally safe and led to robust HBsAg declines; no HBsAg seroclearance was observed.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"410\" src=\"https:\/\/cri1149.fr\/wp-content\/uploads\/2026\/06\/ga1_lrg-1024x410.jpg\" alt=\"\" class=\"wp-image-82954\" srcset=\"https:\/\/cri1149.fr\/wp-content\/uploads\/2026\/06\/ga1_lrg-1024x410.jpg 1024w, https:\/\/cri1149.fr\/wp-content\/uploads\/2026\/06\/ga1_lrg-300x120.jpg 300w, https:\/\/cri1149.fr\/wp-content\/uploads\/2026\/06\/ga1_lrg-768x307.jpg 768w, https:\/\/cri1149.fr\/wp-content\/uploads\/2026\/06\/ga1_lrg-1536x614.jpg 1536w, https:\/\/cri1149.fr\/wp-content\/uploads\/2026\/06\/ga1_lrg-2048x819.jpg 2048w, https:\/\/cri1149.fr\/wp-content\/uploads\/2026\/06\/ga1_lrg-1320x528.jpg 1320w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n","protected":false},"featured_media":82955,"template":"","meta":{"_acf_changed":true},"category_publication":[402],"class_list":["post-82942","publication","type-publication","status-publish","has-post-thumbnail","hentry","category_publication-publications-mises-en-avant"],"acf":{"numero_de_publication":"Clin Gastroenterol Hepatol.","date_de_publication":"20260619","numero_doi":"10.1016\/j.cgh.2026.06.018","equipe":[331],"auteurs-liste":[{"texte_libre":false,"auteur-lien":78525,"auteur-text":""},{"texte_libre":true,"auteur-lien":null,"auteur-text":"Scott K Fung"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"Sila Akhan"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"Wan-Long Chuang"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"Maria Buti"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"Maurizia Brunetto"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"Kosh Agarwal"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"Camellia Diba"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"John Jezorwski"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"V\u00e9ronique Berger"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"Huybrecht T'jollyn"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"Wen-I Tsou"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"Thomas N Kakuda"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"Isabelle Lonjon-Domanec"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"Catherine Nalpas"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"Carine Guinard-Azadian"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"Thierry Verbinnen"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"Erkki Lathouwers"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"An De Creus"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"Oliver Lenz"},{"texte_libre":true,"auteur-lien":null,"auteur-text":"Michael Biermer"}],"auteurs-manuel":"","liens_externes":[{"url":"https:\/\/pubmed.ncbi.nlm.nih.gov\/42320551\/"}],"liens":null,"paragraphe":"","paragraphe_en":"","documents":null},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>No impact of low-dose nivolumab addition to JNJ-73763989 on HBsAg declines in chronic hepatitis B: the OCTOPUS-1 study - CRI<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cri1149.fr\/en\/publication\/no-impact-of-low-dose-nivolumab-addition-to-jnj-73763989-on-hbsag-declines-in-chronic-hepatitis-b-the-octopus-1-study\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"No impact of low-dose nivolumab addition to JNJ-73763989 on HBsAg declines in chronic hepatitis B: the OCTOPUS-1 study - CRI\" \/>\n<meta property=\"og:description\" content=\"Abstract Background &amp; aims:&nbsp;JNJ-73763989 (JNJ-3989)-based treatments (evaluations ongoing) reduce HBsAg in chronic hepatitis B (CHB) patients, but HBsAg seroclearance is rare. OCTOPUS-1, an open-label, randomized phase 2 study, assessed the efficacy and safety of adding low-dose nivolumab (PD-1 inhibitor) to JNJ-3989+nucleos(t)ide analog (NA). 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