Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy
| Autor: | Marion G. Peters, Yasuhito Tanaka, Won Seog Kim, Xiaonan Hong, Kensei Tobinai, Shigeru Kusumoto, Andrew D. Zelenetz, Hiroshi Kuriki, Eisuke Ueda, Jie Jin, Günter Fingerle-Rowson, Hanna Piper-Lepoutre, Luca Arcaini, Tina Nielsen, Yok-Lam Kwong, Gila Sellam |
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| Rok vydání: | 2019 |
| Předmět: |
Male
Clinical Trials and Observations medicine.disease_cause Biochemistry Gastroenterology chemistry.chemical_compound Antineoplastic Agents Immunological 0302 clinical medicine Obinutuzumab Interquartile range Medicine Prospective Studies Aged 80 and over Hazard ratio virus diseases Hematology Middle Aged Hepatitis B Prognosis 030220 oncology & carcinogenesis Female 030211 gastroenterology & hepatology Rituximab Immunotherapy medicine.drug Adult Hepatitis B virus medicine.medical_specialty Lymphoma B-Cell Immunology Antibodies Monoclonal Humanized Antiviral Agents 03 medical and health sciences Internal medicine Humans Aged Hepatitis business.industry Cell Biology medicine.disease digestive system diseases Lymphoma chemistry DNA Viral Virus Activation business Follow-Up Studies |
| Zdroj: | Blood. 133:137-146 |
| ISSN: | 1528-0020 0006-4971 |
| DOI: | 10.1182/blood-2018-04-848044 |
| Popis: | 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). |
| Databáze: | OpenAIRE |
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