{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T15:28:08Z","timestamp":1786116488529,"version":"build-2736575974"},"reference-count":17,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T00:00:00Z","timestamp":1785974400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Curr. Oncol.","Current Oncology"],"abstract":"<jats:p>Background: Immune checkpoint inhibitors (ICIs) are widely used in cancer treatment, but their safety in patients with pre-existing hepatitis B virus (HBV) infection remains uncertain. HBV reactivation is a recognized complication of immunosuppressive cancer therapy, yet evidence supporting routine antiviral prophylaxis during ICI treatment is limited. This study evaluated HBV reactivation and HBV-related outcomes among HBV-positive cancer patients receiving ICIs. Methods: This multicenter retrospective cohort study included adult patients treated with ICIs between January 2017 and December 2022. Patients were grouped according to receipt of antiviral prophylaxis. The primary outcome was HBV reactivation during ICI therapy. Secondary outcomes included hepatic flare, severity, and timing of reactivation, response to antiviral therapy, and factors associated with HBV-related outcomes. Results: A total of 160 patients were included; 68 received antiviral prophylaxis and 92 did not. HBV reactivation occurred in 3 patients (1.9%) and the odd ratio between antiviral prophylaxis and HBV reactivation was wide and imprecise (2.76; 95% CI 0.25\u201331.05). Hepatic flare occurred in 16 patients (10.0%) and was more frequent in the prophylaxis group than in the no-prophylaxis group (19.1% vs. 3.3%; p = 0.001). Conclusion: In this multicenter retrospective cohort study, the HBV reactivation rate was low and could not determine whether antiviral prophylaxis reduced the risk of reactivation. Hepatic flares were significantly more common among patients who received antiviral prophylaxis, likely reflecting a higher baseline risk of HBV-related complications in this group. A future randomized controlled trial is warranted to guide risk-adapted antiviral prophylaxis and monitoring.<\/jats:p>","DOI":"10.3390\/curroncol33080469","type":"journal-article","created":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T09:46:38Z","timestamp":1786009598000},"page":"469","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Safety of Immune Checkpoint Inhibitors in Hepatitis B Virus-Positive Cancer Patients: A Multicenter Retrospective Cohort Study"],"prefix":"10.3390","volume":"33","author":[{"given":"Meshail","family":"Baswaid","sequence":"first","affiliation":[{"name":"Pharmaceutical Care Department, International Medical Center Hospital, Jeddah 23214, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0171-7391","authenticated-orcid":false,"given":"Alaa","family":"Shahbar","sequence":"additional","affiliation":[{"name":"Pharmaceutical Practices Department, College of Pharmacy, Umm Al-Qura University, Makkah 21955, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Afnan","family":"Noor","sequence":"additional","affiliation":[{"name":"Pharmaceutical Care Department, King Faisal Specialist Hospital & Research Center, Jeddah 22234, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danyah Ahmed","family":"Katlan","sequence":"additional","affiliation":[{"name":"Pharmaceutical Care Department, King Fahad Armed Forces Hospital, Jeddah 23311, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5433-6322","authenticated-orcid":false,"given":"Abdulfattah","family":"Alhazmi","sequence":"additional","affiliation":[{"name":"Pharmaceutical Practices Department, College of Pharmacy, Umm Al-Qura University, Makkah 21955, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5279-5437","authenticated-orcid":false,"given":"Mohammed","family":"Alnuhait","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, College of Pharmacy, Shaqra University, Al-Dawadmi 11961, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aryaf","family":"Alsulami","sequence":"additional","affiliation":[{"name":"Pharmaceutical Care Department, King Faisal Specialist Hospital & Research Center, Jeddah 22234, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Baker","family":"Saemaldaher","sequence":"additional","affiliation":[{"name":"College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Jeddah 21423, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hussam","family":"Magliah","sequence":"additional","affiliation":[{"name":"College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Jeddah 21423, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,8,6]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"771","DOI":"10.1177\/10781552211017634","article-title":"Safety and discontinuation rate of immune checkpoint inhibitors used in patients with solid and hematological malignancies: A population-based retrospective analysis","volume":"28","author":"Shahbar","year":"2022","journal-title":"J. Oncol. Pharm. Pract."},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Lao, Y., Shen, D., Zhang, W., He, R., and Jiang, M. (2022). Immune checkpoint inhibitors in cancer therapy: How to overcome drug resistance?. Cancers, 14.","DOI":"10.3390\/cancers14153575"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"254","DOI":"10.1038\/s41571-022-00600-w","article-title":"Immune-checkpoint inhibitors: Long-term implications of toxicity","volume":"19","author":"Johnson","year":"2022","journal-title":"Nat. Rev. Clin. Oncol."},{"key":"ref_4","first-page":"100446","article-title":"Immune checkpoint inhibitors in patients with cancer and infection by hepatitis B or C virus: A perspective through the results of a European survey","volume":"4","author":"Tagliamento","year":"2022","journal-title":"JTO Clin. Res. Rep."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"291","DOI":"10.1016\/j.gendis.2019.12.014","article-title":"Obstacles and opportunities in the prevention and treatment of HBV-related hepatocellular carcinoma","volume":"7","author":"Liao","year":"2020","journal-title":"Genes Dis."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"110107","DOI":"10.4254\/wjh.v17.i10.110107","article-title":"Hepatitis B functional cure: Current and future perspective","volume":"17","author":"Marrapu","year":"2025","journal-title":"World J. Hepatol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"2492","DOI":"10.1016\/S0140-6736(17)31046-2","article-title":"Nivolumab in patients with advanced hepatocellular carcinoma: CheckMate 040: An open-label, non-comparative, phase 1\/2 dose escalation and expansion trial","volume":"389","author":"Sangro","year":"2017","journal-title":"Lancet"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"322","DOI":"10.1186\/s40425-019-0808-5","article-title":"Hepatitis B virus reactivation in cancer patients with positive hepatitis B surface antigen undergoing PD-1 inhibition","volume":"7","author":"Zhang","year":"2019","journal-title":"J. Immunother. Cancer."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"3698","DOI":"10.1200\/JCO.20.01757","article-title":"Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update","volume":"38","author":"Hwang","year":"2020","journal-title":"J. Clin. Oncol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"111","DOI":"10.36401\/JIPO-23-28","article-title":"Management of hepatitis B virus and hepatitis C virus infections in patients with cancer receiving immune checkpoint inhibitors","volume":"7","author":"Mustafayev","year":"2024","journal-title":"J. Immunother. Precis. Oncol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"e001072","DOI":"10.1136\/jitc-2020-001072","article-title":"Risk of HBV reactivation in patients with immune checkpoint inhibitor-treated unresectable hepatocellular carcinoma","volume":"8","author":"Lee","year":"2020","journal-title":"J. Immunother. Cancer."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"102011","DOI":"10.1016\/j.ctrv.2020.102011","article-title":"The safety and efficacy of immune checkpoint inhibitors in patients with advanced cancers and pre-existing chronic viral infections: Hepatitis B\/C and HIV: A review of the available evidence","volume":"86","author":"Chan","year":"2020","journal-title":"Cancer Treat. Rev."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"898","DOI":"10.1016\/j.cgh.2021.06.019","article-title":"Risk of hepatitis B virus reactivation in patients treated with immunotherapy for anti-cancer treatment","volume":"20","author":"Yoo","year":"2022","journal-title":"Clin. Gastroenterol. Hepatol."},{"key":"ref_14","doi-asserted-by":"crossref","unstructured":"Inuzuka, T., Takai, A., Ueno, M., Mishima, M., Takeda, H., Takahashi, K., Kayahara, T., Takabatake, H., Mouri, H., and Seno, H. (2026). True reactivation versus transient viremia: A retrospective analysis of HBV reactivation in resolved infection. Sci. Rep.","DOI":"10.1038\/s41598-026-56251-9"},{"key":"ref_15","doi-asserted-by":"crossref","unstructured":"Lasagna, A., Albi, G., Maserati, R., Zuccarini, A., Quaccini, M., Baldanti, F., Sacchi, P., Bruno, R., and Pedrazzoli, P. (2023). Occult hepatitis B in patients with cancer during immunotherapy with or without chemotherapy: A real-life retrospective single-center cohort study. Front Oncol., 13.","DOI":"10.3389\/fonc.2023.1044098"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1577","DOI":"10.2217\/fon-2020-1196","article-title":"Risk of reactivation of occult hepatitis B during immunotherapy in cancer treatment: Myth, reality or new horizons?","volume":"17","author":"Lasagna","year":"2021","journal-title":"Future Oncol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"452","DOI":"10.1016\/j.dld.2020.08.041","article-title":"Hepatitis B reactivation and immune check point inhibitors","volume":"53","author":"Godbert","year":"2021","journal-title":"Dig. Liver Dis."}],"container-title":["Current Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1718-7729\/33\/8\/469\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T10:31:49Z","timestamp":1786012309000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1718-7729\/33\/8\/469"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,6]]},"references-count":17,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2026,8]]}},"alternative-id":["curroncol33080469"],"URL":"https:\/\/doi.org\/10.3390\/curroncol33080469","relation":{},"ISSN":["1718-7729"],"issn-type":[{"value":"1718-7729","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,6]]}}}