Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy

Risk of hepatitis B virus (HBV) reactivation was assessed in B-cell non-Hodgkin lymphoma (NHL) patients with resolved HBV infection (hepatitis B surface antigen negative, hepatitis B core antibody positive) who received obinutuzumab- or rituximab-containing immunochemotherapy in the phase 3 GOYA and...

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Veröffentlicht in:	Blood 2019-01, Vol.133 (2), p.137-146
Hauptverfasser:	Kusumoto, Shigeru, Arcaini, Luca, Hong, Xiaonan, Jin, Jie, Kim, Won Seog, Kwong, Yok Lam, Peters, Marion G., Tanaka, Yasuhito, Zelenetz, Andrew D., Kuriki, Hiroshi, Fingerle-Rowson, Günter, Nielsen, Tina, Ueda, Eisuke, Piper-Lepoutre, Hanna, Sellam, Gila, Tobinai, Kensei
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Schlagworte:	Adult Aged Aged, 80 and over Antibodies, Monoclonal, Humanized - adverse effects Antineoplastic Agents, Immunological - adverse effects Antiviral Agents - therapeutic use Clinical Trials and Observations DNA, Viral - genetics Female Follow-Up Studies Hepatitis B - chemically induced Hepatitis B - drug therapy Hepatitis B - virology Hepatitis B virus - drug effects Hepatitis B virus - genetics Humans Immunotherapy - adverse effects Lymphoma, B-Cell - drug therapy Lymphoma, B-Cell - immunology Lymphoma, B-Cell - virology Male Middle Aged Prognosis Prospective Studies Rituximab - adverse effects Virus Activation - drug effects
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creator	Kusumoto, Shigeru Arcaini, Luca Hong, Xiaonan Jin, Jie Kim, Won Seog Kwong, Yok Lam Peters, Marion G. Tanaka, Yasuhito Zelenetz, Andrew D. Kuriki, Hiroshi Fingerle-Rowson, Günter Nielsen, Tina Ueda, Eisuke Piper-Lepoutre, Hanna Sellam, Gila Tobinai, Kensei
description	Risk of hepatitis B virus (HBV) reactivation was assessed in B-cell non-Hodgkin lymphoma (NHL) patients with resolved HBV infection (hepatitis B surface antigen negative, hepatitis B core antibody positive) who received obinutuzumab- or rituximab-containing immunochemotherapy in the phase 3 GOYA and GALLIUM studies. HBV DNA monitoring was undertaken monthly to 1 year after the last dose of study drug. In case of HBV reactivation (confirmed, HBV DNA ≥29 IU/mL), immunochemotherapy was withheld and nucleos(t)ide analog treatment (preemptive NAT) started. Immunochemotherapy was restarted if HBV DNA became undetectable or reactivation was not confirmed, and discontinued if HBV DNA exceeded 100 IU/mL on NAT. Prophylactic NAT was allowed by investigator discretion. Among 326 patients with resolved HBV infection, 27 (8.2%) had HBV reactivation, occurring a median of 125 days (interquartile range, 85-331 days) after the first dose. In 232 patients without prophylactic NAT, 25 (10.8%) had HBV reactivation; all received preemptive NAT. Ninety-four patients received prophylactic NAT; 2 (2.1%) had HBV reactivation. No patients developed HBV-related hepatitis. On multivariate Cox analysis, detectable HBV DNA at baseline was strongly associated with an increased risk of reactivation (adjusted hazard ratio [HR], 18.22; 95% confidence interval [CI], 6.04-54.93; P < .0001). Prophylactic NAT was strongly associated with a reduced risk (adjusted HR, 0.09; 95% CI, 0.02-0.41; P = .0018). HBV DNA monitoring–guided preemptive NAT was effective in preventing HBV-related hepatitis during anti–CD20-containing immunochemotherapy in B-cell NHL patients with resolved HBV infection. Antiviral prophylaxis was also effective and may be appropriate for high-risk patients. These trials were registered at www.clinicaltrials.gov as NCT01287741 (GOYA) and NCT01332968 (GALLIUM). •HBV DNA monitoring–guided preemptive nucleos(t)ide therapy can prevent HBV hepatitis during anti-CD20 immunochemotherapy in B-cell NHL.•Prophylactic nucleos(t)ide therapy can prevent HBV reactivation and may be appropriate for high-risk patients. [Display omitted]
doi_str_mv	10.1182/blood-2018-04-848044
format	Article
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HBV DNA monitoring was undertaken monthly to 1 year after the last dose of study drug. In case of HBV reactivation (confirmed, HBV DNA ≥29 IU/mL), immunochemotherapy was withheld and nucleos(t)ide analog treatment (preemptive NAT) started. Immunochemotherapy was restarted if HBV DNA became undetectable or reactivation was not confirmed, and discontinued if HBV DNA exceeded 100 IU/mL on NAT. Prophylactic NAT was allowed by investigator discretion. Among 326 patients with resolved HBV infection, 27 (8.2%) had HBV reactivation, occurring a median of 125 days (interquartile range, 85-331 days) after the first dose. In 232 patients without prophylactic NAT, 25 (10.8%) had HBV reactivation; all received preemptive NAT. Ninety-four patients received prophylactic NAT; 2 (2.1%) had HBV reactivation. No patients developed HBV-related hepatitis. On multivariate Cox analysis, detectable HBV DNA at baseline was strongly associated with an increased risk of reactivation (adjusted hazard ratio [HR], 18.22; 95% confidence interval [CI], 6.04-54.93; P < .0001). Prophylactic NAT was strongly associated with a reduced risk (adjusted HR, 0.09; 95% CI, 0.02-0.41; P = .0018). HBV DNA monitoring–guided preemptive NAT was effective in preventing HBV-related hepatitis during anti–CD20-containing immunochemotherapy in B-cell NHL patients with resolved HBV infection. Antiviral prophylaxis was also effective and may be appropriate for high-risk patients. These trials were registered at www.clinicaltrials.gov as NCT01287741 (GOYA) and NCT01332968 (GALLIUM). •HBV DNA monitoring–guided preemptive nucleos(t)ide therapy can prevent HBV hepatitis during anti-CD20 immunochemotherapy in B-cell NHL.•Prophylactic nucleos(t)ide therapy can prevent HBV reactivation and may be appropriate for high-risk patients. [Display omitted]</description><identifier>ISSN: 0006-4971</identifier><identifier>EISSN: 1528-0020</identifier><identifier>DOI: 10.1182/blood-2018-04-848044</identifier><identifier>PMID: 30341058</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal, Humanized - adverse effects ; Antineoplastic Agents, Immunological - adverse effects ; Antiviral Agents - therapeutic use ; Clinical Trials and Observations ; DNA, Viral - genetics ; Female ; Follow-Up Studies ; Hepatitis B - chemically induced ; Hepatitis B - drug therapy ; Hepatitis B - virology ; Hepatitis B virus - drug effects ; Hepatitis B virus - genetics ; Humans ; Immunotherapy - adverse effects ; Lymphoma, B-Cell - drug therapy ; Lymphoma, B-Cell - immunology ; Lymphoma, B-Cell - virology ; Male ; Middle Aged ; Prognosis ; Prospective Studies ; Rituximab - adverse effects ; Virus Activation - drug effects</subject><ispartof>Blood, 2019-01, Vol.133 (2), p.137-146</ispartof><rights>2019 American Society of Hematology</rights><rights>2019 by The American Society of Hematology.</rights><rights>2019 by The American Society of Hematology 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c463t-9a8027da34ddc804ec0aa874cce49d1bfc85e082f6cc8fea112fc8536fbf12f53</citedby><cites>FETCH-LOGICAL-c463t-9a8027da34ddc804ec0aa874cce49d1bfc85e082f6cc8fea112fc8536fbf12f53</cites><orcidid>0000-0001-6546-1279</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30341058$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kusumoto, Shigeru</creatorcontrib><creatorcontrib>Arcaini, Luca</creatorcontrib><creatorcontrib>Hong, Xiaonan</creatorcontrib><creatorcontrib>Jin, Jie</creatorcontrib><creatorcontrib>Kim, Won Seog</creatorcontrib><creatorcontrib>Kwong, Yok Lam</creatorcontrib><creatorcontrib>Peters, Marion G.</creatorcontrib><creatorcontrib>Tanaka, Yasuhito</creatorcontrib><creatorcontrib>Zelenetz, Andrew D.</creatorcontrib><creatorcontrib>Kuriki, Hiroshi</creatorcontrib><creatorcontrib>Fingerle-Rowson, Günter</creatorcontrib><creatorcontrib>Nielsen, Tina</creatorcontrib><creatorcontrib>Ueda, Eisuke</creatorcontrib><creatorcontrib>Piper-Lepoutre, Hanna</creatorcontrib><creatorcontrib>Sellam, Gila</creatorcontrib><creatorcontrib>Tobinai, Kensei</creatorcontrib><title>Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy</title><title>Blood</title><addtitle>Blood</addtitle><description>Risk of hepatitis B virus (HBV) reactivation was assessed in B-cell non-Hodgkin lymphoma (NHL) patients with resolved HBV infection (hepatitis B surface antigen negative, hepatitis B core antibody positive) who received obinutuzumab- or rituximab-containing immunochemotherapy in the phase 3 GOYA and GALLIUM studies. HBV DNA monitoring was undertaken monthly to 1 year after the last dose of study drug. In case of HBV reactivation (confirmed, HBV DNA ≥29 IU/mL), immunochemotherapy was withheld and nucleos(t)ide analog treatment (preemptive NAT) started. Immunochemotherapy was restarted if HBV DNA became undetectable or reactivation was not confirmed, and discontinued if HBV DNA exceeded 100 IU/mL on NAT. Prophylactic NAT was allowed by investigator discretion. Among 326 patients with resolved HBV infection, 27 (8.2%) had HBV reactivation, occurring a median of 125 days (interquartile range, 85-331 days) after the first dose. In 232 patients without prophylactic NAT, 25 (10.8%) had HBV reactivation; all received preemptive NAT. Ninety-four patients received prophylactic NAT; 2 (2.1%) had HBV reactivation. No patients developed HBV-related hepatitis. On multivariate Cox analysis, detectable HBV DNA at baseline was strongly associated with an increased risk of reactivation (adjusted hazard ratio [HR], 18.22; 95% confidence interval [CI], 6.04-54.93; P < .0001). Prophylactic NAT was strongly associated with a reduced risk (adjusted HR, 0.09; 95% CI, 0.02-0.41; P = .0018). HBV DNA monitoring–guided preemptive NAT was effective in preventing HBV-related hepatitis during anti–CD20-containing immunochemotherapy in B-cell NHL patients with resolved HBV infection. Antiviral prophylaxis was also effective and may be appropriate for high-risk patients. These trials were registered at www.clinicaltrials.gov as NCT01287741 (GOYA) and NCT01332968 (GALLIUM). •HBV DNA monitoring–guided preemptive nucleos(t)ide therapy can prevent HBV hepatitis during anti-CD20 immunochemotherapy in B-cell NHL.•Prophylactic nucleos(t)ide therapy can prevent HBV reactivation and may be appropriate for high-risk patients. [Display omitted]</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antibodies, Monoclonal, Humanized - adverse effects</subject><subject>Antineoplastic Agents, Immunological - adverse effects</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Clinical Trials and Observations</subject><subject>DNA, Viral - genetics</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Hepatitis B - chemically induced</subject><subject>Hepatitis B - drug therapy</subject><subject>Hepatitis B - virology</subject><subject>Hepatitis B virus - drug effects</subject><subject>Hepatitis B virus - genetics</subject><subject>Humans</subject><subject>Immunotherapy - adverse effects</subject><subject>Lymphoma, B-Cell - drug therapy</subject><subject>Lymphoma, B-Cell - immunology</subject><subject>Lymphoma, B-Cell - virology</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Prognosis</subject><subject>Prospective Studies</subject><subject>Rituximab - adverse effects</subject><subject>Virus Activation - drug effects</subject><issn>0006-4971</issn><issn>1528-0020</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9UdtOxCAUJEaj6-UPjOEHqodCW_bFRI23xMTEqK-EUmrRtlSgq-vXy7peX3zicGDmnJlBaJfAPiE8PShba6skBcITYAlnHBhbQROSpbEBKayiCQDkCZsWZANtev8IQBhNs3W0QYEyAhmfoOcb45-wrfHF8T12WqpgZjIY22PT4yFWug8ev5jQ4ONE6bbF7bwbGttJH78rbWamf8C2NP0YxrexkyW2DjsTxlezuJiuG3urGt3Z0Ggnh_k2Wqtl6_XO57mF7s5Ob08ukqvr88uTo6tEsZyGZCo5pEUlKasqFbVpBVLygiml2bQiZa14poGnda4Ur7UkJF20aF6XdSwzuoUOl7zDWHa6UlGIk60YXNzLzYWVRvx96U0jHuxM5JQWvKCRgC0JlLPeO11_YwmIRQTiIwKxiEAAE8sIImzv99xv0JfnP4vpqH5mtBNeRZuVrkx0NIjKmv8nvAMqR52C</recordid><startdate>20190110</startdate><enddate>20190110</enddate><creator>Kusumoto, Shigeru</creator><creator>Arcaini, Luca</creator><creator>Hong, Xiaonan</creator><creator>Jin, Jie</creator><creator>Kim, Won Seog</creator><creator>Kwong, Yok Lam</creator><creator>Peters, Marion G.</creator><creator>Tanaka, Yasuhito</creator><creator>Zelenetz, Andrew D.</creator><creator>Kuriki, Hiroshi</creator><creator>Fingerle-Rowson, Günter</creator><creator>Nielsen, Tina</creator><creator>Ueda, Eisuke</creator><creator>Piper-Lepoutre, Hanna</creator><creator>Sellam, Gila</creator><creator>Tobinai, Kensei</creator><general>Elsevier Inc</general><general>American Society of Hematology</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6546-1279</orcidid></search><sort><creationdate>20190110</creationdate><title>Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy</title><author>Kusumoto, Shigeru ; 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HBV DNA monitoring was undertaken monthly to 1 year after the last dose of study drug. In case of HBV reactivation (confirmed, HBV DNA ≥29 IU/mL), immunochemotherapy was withheld and nucleos(t)ide analog treatment (preemptive NAT) started. Immunochemotherapy was restarted if HBV DNA became undetectable or reactivation was not confirmed, and discontinued if HBV DNA exceeded 100 IU/mL on NAT. Prophylactic NAT was allowed by investigator discretion. Among 326 patients with resolved HBV infection, 27 (8.2%) had HBV reactivation, occurring a median of 125 days (interquartile range, 85-331 days) after the first dose. In 232 patients without prophylactic NAT, 25 (10.8%) had HBV reactivation; all received preemptive NAT. Ninety-four patients received prophylactic NAT; 2 (2.1%) had HBV reactivation. No patients developed HBV-related hepatitis. On multivariate Cox analysis, detectable HBV DNA at baseline was strongly associated with an increased risk of reactivation (adjusted hazard ratio [HR], 18.22; 95% confidence interval [CI], 6.04-54.93; P < .0001). Prophylactic NAT was strongly associated with a reduced risk (adjusted HR, 0.09; 95% CI, 0.02-0.41; P = .0018). HBV DNA monitoring–guided preemptive NAT was effective in preventing HBV-related hepatitis during anti–CD20-containing immunochemotherapy in B-cell NHL patients with resolved HBV infection. Antiviral prophylaxis was also effective and may be appropriate for high-risk patients. These trials were registered at www.clinicaltrials.gov as NCT01287741 (GOYA) and NCT01332968 (GALLIUM). •HBV DNA monitoring–guided preemptive nucleos(t)ide therapy can prevent HBV hepatitis during anti-CD20 immunochemotherapy in B-cell NHL.•Prophylactic nucleos(t)ide therapy can prevent HBV reactivation and may be appropriate for high-risk patients. 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subjects	Adult Aged Aged, 80 and over Antibodies, Monoclonal, Humanized - adverse effects Antineoplastic Agents, Immunological - adverse effects Antiviral Agents - therapeutic use Clinical Trials and Observations DNA, Viral - genetics Female Follow-Up Studies Hepatitis B - chemically induced Hepatitis B - drug therapy Hepatitis B - virology Hepatitis B virus - drug effects Hepatitis B virus - genetics Humans Immunotherapy - adverse effects Lymphoma, B-Cell - drug therapy Lymphoma, B-Cell - immunology Lymphoma, B-Cell - virology Male Middle Aged Prognosis Prospective Studies Rituximab - adverse effects Virus Activation - drug effects
title	Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy
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