Current treatment with anti-viral therapy for hepatitis B virus (HBV)
Patients with hepatitis B virus (HBV) infection are eligible provided they meet the other eligibility criteria and:\r\n* There is no evidence of hepatic damage related to HBV infection\r\n* They have had consistently suppressed HBV viral load to undetectable levels by polymerase chain reaction (PCR) for a minimum of 12 months
Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive HBcAb test.
Subjects with positive HBV core antibody or surface antigen are eligible as long as they have an undetectable HBV DNA PCR, and receive concurrent antiviral therapy with entecavir, tenofovir, or lamivudine, and continued for a minimum of 6 months after completion of therapy.
Negative hepatitis B surface antigen (HBsAg) and undetectable hepatitis B virus (HBV) DNA
HBV surface antigen (HBsAg) negative, HBV surface ant ibody (ant i-HBs) posit ive and/or HBV core antibody (ant i-HBc) positive, and detectable viral DNA Subjects who are seropositive because of prior HBV vaccination are eligible (anti- HBs positive, anti-HBc negative, and HBsAg negative).
Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study if active HBV infection is ruled out on the basis of HBV DNA viral load per local guidelines.
Obtained within 14 days prior to C1D1: Hepatitis B virus (HBV) surface antigen negative
Obtained within 14 days prior to C1D1: HBV surface antibody positive or negative
Obtained within 14 days prior to C1D1: HBV core antibody negative\r\n* Subjects whose HBV core antibody is positive must have a negative HBV viral load measurement
Obtained within 14 days prior to C1D1: HBV viral load negative
Suppression of hepatitis B (HBV) (=< 100 IU/mL by HBV polymerase chain reaction [PCR]) with antivirals per the local standard of care if prior or current HBV exposure or infection
If active hepatitis B virus (HBV), viral load must be < 100 IU/mL; if active HBV, subjects must be on anti-viral medication for >= 3 months prior to study registration and remain on the same anti-viral regimen throughout study treatment; NOTE: those subjects who are positive for hepatitis B core antibody (anti-HBc), negative for hepatitis B surface antigen (HBsAg) and negative for hepatitis B surface antibody (anti-HBs), and have an HBV viral load < 100 IU/mL do not require HBV anti-viral prophylaxis
Known active hepatitis B (hepatitis B virus [HBV]) or hepatitis C (hepatitis C virus [HCV]) infection; patients who are positive only for HBV surface antibody as a result of prior vaccination are eligible; patients with a positive HBV core antibody but undetectable HBV viral load are eligible
Seropositive for or active viral infection with hepatitis B virus (HBV):\r\n* Hepatitis B surface antigen (HBsAg) positive\r\n* HBsAg negative, anti-hepatitis B surface antibody (HBs) positive and/or anti-hepatitis B core antibody (HBc) positive and detectable viral deoxyribonucleic acid (DNA)\r\nNotes:\r\n* Subjects who are HBsAg negative, anti-HBs positive, and/or anti-HBc positive, but viral DNA negative are eligible\r\n* Subjects who are seropositive because of HBV vaccination are eligible (HBV surface antibody positive, HBV core antibody negative, and HBV surface antigen negative)
Active human immunodeficiency virus (HIV) infection or infectious hepatitis, type B or C.\r\n* Patients with a past or resolved hepatitis B virus (HBV) infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of hepatitis B surface antigen [HBsAg]) may be included if HBV deoxyribonucleic acid (DNA) is undetectable. If enrolled, patients must be willing to undergo monthly HBV DNA testing.\r\n* HIV positive patients may enroll if they meet all of the below criteria:\r\n** HIV is sensitive to antiretroviral therapy.\r\n** Must be willing to take effective antiretroviral therapy if indicated.\r\n** No history of CD4 prior to or at the time of lymphoma diagnosis < 300 cells/mm^3.\r\n** No history of acquired immunodeficiency syndrome (AIDS)-defining conditions.\r\n** If on antiretroviral therapy, must not be taking zidovudine or stavudine.\r\n** Must be willing to take prophylaxis for pneumocystis jiroveci pneumonia (PCP) during therapy and until at least 2 months following the completion of therapy or until the CD4 cells recover to over 250 cells/mm^3, whichever occurs later.
If HBV surface antigen (sAg) and/or core antibody (Ab) positive, must be treated with appropriate antiviral therapy according to institutional practice with HBV deoxyribonucleic acid (DNA) by polymerase chain reaction (PCR) less than 500 IU/mL
Participant is known to be positive for hepatitis B or C infection [HCV Ab indicative of a previous or current infection; and/or positive HBs Ag or detected sensitivity on HBV DNA PCR test for HBc Ab and/or HBs Ab positivity] with the exception of those with an undetectable viral load within 3 months screening. Hepatitis B or C testing is not required.
Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
The HBV DNA test will be performed only for patients who have a positive HBcAb test
Current treatment with anti-viral therapy for HBV.
Current treatment with anti-viral therapy for hepatitis B virus (HBV)
Antiviral therapy per local standard of care with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < 100 IU/ml if active hepatitis B (HBV) infection
Known active hepatitis B or hepatitis C virus (HBV or HCV):\r\n* Patients with past or resolved HBV infection (defined by a negative hepatitis B surface antigen [HBsAg] test and a positive anti-hepatitis B core antigen [anti-HBc] antibody test) are eligible; HBV DNA must be obtained in these patients prior to first day of study treatment\r\n*Patients who have been recently discovered to have HBV with positive HBsAg test and positive anti-HBc antibody test but who have been started on antiretroviral treatment with non-detectable HBV DNA are eligible; HBV DNA must be obtained in these patients prior to first day of study treatment
Has known chronic or acute hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C infection (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)\r\n* Note: To qualify for enrollment, antiviral therapy for hepatitis B virus (HBV) must be given for at least 3 months, and HBV viral load must be less than 100 IU/mL prior to first dose of stud drug; those on active HBV therapy with viral loads under 100 IU/mL should stay on the same therapy throughout trial treatment; those subjects who are hepatitis B virus core antibody (anti-HBc) (+), and negative for HBsAg, and negative for hepatitis B virus surface antibody (anti-HBs), and have an HBV viral load under 100 IU/mL do not require HBV anti-viral prophylaxis, but need close monitoring
Known hepatitis B virus (HBV) surface antigen seropositive or detectable hepatitis C virus (HCV) infection viral load. Note: Participants who have positive HBV core antibody or HBV surface antigen antibody can be enrolled but must have an undetectable HBV viral load.
Participants with dual active hepatitis B virus (HBV) infection (hepatitis B surface antigen [HBsAg] positive [+] and /or detectable HBV deoxyribonucleic acid [DNA]) and, hepatitis C virus (HCV) infection (anti-HCV antibody [Ab] [+] and detectable HCV ribonucleic acid [RNA]) at study entry\r\n* Subjects with chronic infection by HCV who are treated with anti-hepatitis B therapy (successfully or treatment failure) or untreated are allowed on study; controlled (treated) hepatitis B subjects will be allowed if they meet the following criteria:\r\n** Antiviral therapy for HBV must be given for at least 12 weeks and HBV viral load must be less than 100 IU/mL prior to first dose of study drug; subjects on active HBV therapy with viral loads under 100 IU/ml should stay on the same therapy throughout study\r\ntreatment\r\n** Subjects who are anti-HBc (+), negative for HBsAg, negative for anti-HBs, and have a HBV viral load under 100 IU/mL do not require HBV anti-viral prophylaxis\r\n* In addition, subjects with successful HCV treatment are allowed as long as there are >= 4 weeks between achieving sustained viral response (SVR) and start of study drug
Patients with hepatitis B virus (HBV) viral load > 100 IU/mL (antiviral therapy per local practice is required)
Active hepatitis B infection (defined as the presence of detectable hepatitis B virus [HBV] deoxyribonucleic acid [DNA] or hemoglobin E [HBe] antigen). Patients who are hepatitis B surface antigen (HBsAg) negative/hepatitis B surface antibody (HBsAb) positive but hepatitis B core antibody (HBcAb) positive are eligible, provided HBV DNA is negative. These patients must have monthly monitoring of HBV DNA for the duration of the study
Subjects with chronic infection by HCV who are treated or untreated are allowed on study; subjects with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test and negative HBV deoxyribonucleic acid (DNA) test at screening, are eligible for the study; in addition, subjects with successful treatment (defined as sustained virologic response [SVR12] or SVR24) are allowed as long as 4 weeks have passed between completion of HCV therapy and start of study drug
Has untreated active hepatitis B; Note: to qualify for enrollment, antiviral therapy for HBV must be given for at least 3 months prior to first dose of study drug, and HBV viral load must be less than 100 IU/mL prior to first dose of study drug; those on active HBV therapy with viral loads under 100 IU/mL should stay on the same therapy throughout study treatment; those subjects who are anti-HBc (+) and negative for HBsAg, Anti-HBs, and HBV viral load do not require HBV prophylaxis, but need close monitoring for reactivation
Patients with chronic hepatitis B are eligible as long as they have evidence of ongoing viral replication (detectable hepatitis B surface antigen [HBsAg], hepatitis B envelope antigen [HBeAg], or hepatitis B virus [HBV] deoxyribonucleic acid [DNA]); they must have HBV DNA viral load < 100 IU/mL at screening; in addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy; if not on antiviral therapy at screening, then the subject must initiate treatment per regional standard of care guidelines at the time of consent; both HBeAg positive and negative patients will be included
PRIOR TO LYMPHODEPLETION: Patients who are hepatitis B surface antigen positive are ineligible; patients who are hepatitis B surface antigen negative but hepatitis B core antibody positive must have their hepatitis B viral load checked; these subjects will be excluded if their viral load is positive; subjects who are core antibody positive and viral load negative will be considered eligible; subjects who are hepatitis B virus (HBV) core antibody positive and HBV viral load negative prior to lymphodepletion must have initiated anti-HBV prophylaxis prior to lymphodepletion
Hepatitis B virus (HBV) surface-antigen positive unless receiving both tenofovir and lamivudine as part of antiretroviral therapy if HIV-infected
Evidence of active acute or chronic hepatitis B (HBV); subjects with acute or chronic active HBV will be defined based on Centers for Disease Control and Prevention (CDC) guidelines; this will include subjects with positive serology for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc) associated with HBV-deoxyribonucleic acid (DNA) positive test by real time quantitative polymerase chain reaction (qPCR) assessment; subjects, who are anti-HBc positive and HBsAg negative or HBV-DNA test negative, may be enrolled in the study and should undergo regular monitoring of HBV viral load using HBV-DNA qPCR; those subjects may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management including antiviral therapy
Specific guidelines will be followed regarding inclusion of relapsed/refractory DLBCL based on hepatitis B serological testing as follows:\r\n* Hepatitis B surface antigen (HBsAg) negative, hepatitis B core antibody (HBcAb) negative, hepatitis B surface antibody (HBsAb) positive patients are eligible\r\n* Patients who test positive for HBsAg are ineligible (regardless of other hepatitis B serologies)\r\n* Patients with HBsAg negative, but HBcAb positive (regardless of HBsAb status) should have a hepatitis B virus (HBV) deoxyribonucleic acid (DNA) testing done and protocol eligibility determined as follows:\r\n** If HBV DNA is positive, the subject will be excluded from the study\r\n** If HBV DNA is negative, the subject may be included but must undergo at least every 2 months HBV DNA polymerase chain reaction (PCR) testing from the start of treatment throughout the duration the treatment course
DONOR: Evidence of active infection (including urinary tract infection, or upper respiratory tract infection), viral hepatitis exposure (on screening), unless only hepatitis B surface antibody (HBsAb)+ and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) negative, or serologic of exposure or infection with HIV-I/II or HTLV-I/II
Negative serologies for hepatitis B (HB) defined as a negative test for HB surface antigen (sAg); in addition, if negative for HBsAg but HB core antibody (cAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed and if negative, patient may be included but must undergo hepatitis B virus (HBV) DNA polymerase chain reaction (PCR) testing at the beginning of treatment and throughout treatment duration, at least every 2 months; in addition patients will require treatment with Entecavir 0.5 mg orally (PO) a day (qday) per Memorial Sloan Kettering Cancer Center (MSKCC) institutional guidelines
Patients with known active hepatitis B virus (HBV) infection should be excluded; however, if a patient has HBV history with an undetectable HBV load by polymerase chain reaction (PCR), no liver-related complications, and is on definitive HBV therapy, then he/she would be eligible for study
Patients with positive serology for hepatitis B (HB), defined as a positive test for HB surface antigen (HBsAg), are NOT eligible; if negative for HBsAg but HB core antibody (HBcAb) positive a HB deoxyribonucleic acid (DNA) test will be performed; if HB DNA test is positive the patient is NOT eligible; NOTE: patients who are positive for HBcAb but negative for hepatitis B virus (HBV) antigenemia and viremia (HBsAg negative and HB DNA test negative) may be eligible for the study, but should be referred to hepatology for consultation and must be started on HBV suppression therapy with lamivudine or equivalent anti-HBV agents throughout the treatment and for a year after the completion of the treatments; these patients need to have liver function tests (LFTs) and HBV viral titer monitoring at least monthly during the treatment and for a year after treatment completion
Hepatitis B virus (HBV): negative hepatitis B surface antigen (HBsAg) and negative hepatitis B core (HBc) antibody or positive HBc and negative HBV deoxyribonucleic acid (DNA) by quantitative PCR
Patients must have no evidence of active hepatitis B or C infection (i.e., no positive serology for anti-hepatitis B core [HBc] or anti-hepatitis C virus [HCV] antibodies); hepatitis B virus (HBV) seropositive patients (hepatitis B surface antigen [HBsAg] +) are eligible if HBV deoxyribonucleic acid (DNA) is undetectable at baseline and they are closely monitored for evidence of active HBV infection by HBV DNA testing at each treatment cycle; after completing treatment, HBsAg + patients must be monitored by HBV DNA testing every 2 months for 6 months post-treatment, while continuing lamivudine
Uncontrolled hepatitis B virus (HBV) infection, defined as plasma HBV DNA detectable by polymerase chain reaction (PCR)\r\n* Note: the following will NOT be exclusionary:\r\n** A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute HBV infection\r\n** Patients with chronic HBV suppressed by appropriate antiretroviral therapy with activity against HBV, as outlined in DHHS guidelines
Subject has HBV DNA viral load undetectable or < 100 IU/mL at screening. If subject has detectable HBsAg, HBeAg, or HBV DNA (indicating ongoing viral replication of hepatitis B, he/she must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy. If not on antiviral therapy at screening, then the subject must initiate treatment per regional standard of care guidelines prior to C1D1 and must be willing to continue antiviral therapy while on study treatment.
HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable viral DNA
Subjects who are HBsAg negative, anti-HBs positive, and/or anti-HBc positive, but viral DNA negative are not eligible
Subjects who are seropositive because of HBV vaccination are eligible (HBV surface antibody positive, HBV core antibody negative, and HBV surface antigen negative)
Except in cohort 3, HPV-associated cancers, active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening; patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test and negative HBV deoxyribonucleic acid (DNA) test at screening, are eligible for the study
Subject who is seropositive for or active viral infection with hepatitis B virus (HBV) (hepatitis B surface antigen [HBsAg] positive and/or detectable viral DNA)
HBV viral load (VL) <200 IU/mL (approximately 1000 cps/mL)
Subjects with active HBV infection need to be on anti-HBV suppression ?3 months, throughout treatment and for 6 months after
Patients must be screened for HBV. Patients who are either HBsAg positive or HBV-DNA positive must be willing and able to take antiviral therapy 1-2 weeks prior to 1st dose of EGF816 treatment and continue on antiviral therapy for at least 4 weeks after the last dose of EGF816.
Known to be positive for hepatitis B surface antigen or hepatitis B core antibody; if hepatitis B (HBV) deoxyribonucleic acid (DNA) test is known to be negative, patients seropositive for HBV core antibody (and seronegative for HBV surface antigen) are eligible; NOTE: Does NOT need to be repeated if pre-transplant screening test was negative
Specific guidelines will be followed regarding inclusion of relapsed/refractory DLBCL based on hepatitis B serological testing as follow:\r\n* Hepatitis B surface antigen (HBsAg) negative, hepatitis B virus core antibody (HBcAb) negative, hepatitis B virus surface antibody (HBsAb) negative patients are eligible\r\n* HBsAg negative, HBcAb negative, HBsAb positive patients are eligible\r\n* Patients who test positive for HBsAg are ineligible\r\n* Patients with HBsAg negative, but HBcAb positive (regardless of HBsAb status) should have a hepatitis B virus (HBV) deoxyribonucleic acid (DNA) testing performed and protocol eligibility determined as follow:\r\n** If HBV DNA is positive, the subject is ineligible\r\n** If HBV DNA is negative, the subject may be included but must undergo HBV DNA polymerase chain reaction (PCR) testing monthly x 3 months beginning from the start of treatment
Evidence of active acute or chronic hepatitis B (hepatitis B virus [HBV]): subjects with acute or chronic active HBV will be defined based on Centers for Disease Control and Prevention (CDC) guidelines; this will include subjects with positive serology for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc) associated with HBV-deoxyribonucleic acid (DNA) positive test by real time quantitative polymerase chain reaction (qPCR) assessment; subjects, who are anti-HBc positive and HBsAg negative or HBV-DNA test negative, may be enrolled in the study and should undergo regular monitoring of HBV viral load using HBV-DNA qPCR; those subjects may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management including antiviral therapy
Positive serology for hepatitis B (HB) defined as a positive test for HB surface antigen (HBsAg); in addition, if negative for HBsAg but HB core antibody (HBcAb) positive (regardless of HB surface antibody [HBsAb] status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded\r\n* If HB virus (HBV) DNA is negative, subject may be included but must undergo HBV DNA polymerase chain reaction (PCR) testing at least every 2 months from the start of treatment until 12 months post treatment; prophylactic antiviral therapy may be initiated at the discretion of the investigator
Positive anti-hepatitis B virus (HBV); HBV seropositive patients (hepatitis B surface antigen [HBsAg] positive) are eligible if they are closely monitored for evidence of active HBV infection by HBV deoxyribonucleic acid (DNA) testing, and they must agree to receive suppressive therapy with lamivudine or other HBV-suppressive therapy until at least 4 weeks after the last dose of everolimus; patients who are anti-hepatitis C virus (HCV) positive are eligible provided that hepatitis C viral load (hepatitis C ribonucleic acid [RNA]) is undetectable
Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B virus surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of hepatitis B surface antibody [HBsAb] status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded; HBsAg negative, HBsAb negative, HBsAb positive subjects can be included\r\n* Consult with a physician experienced in care & management of subjects with hepatitis B to manage/treat subjects who are anti-HBc positive\r\n* Monitoring criteria for HBcAb+ and HBV DNA negative subjects:\r\n** If HBV DNA is negative, subject may be included but must undergo at least every 2 month HBV DNA polymerase chain reaction (PCR) testing from the start of treatment during the treatment course\r\n** Monitoring during the follow-up period will be performed during routine study visits for a minimum follow-up period of six months after the last dose, as long as the subject remains on study; monitoring frequency during follow-up should occur at a minimum of every 2-3 months; whenever possible, the monitoring should occur as part of the routine follow-up visit (Note: for most studies, the follow-up visits are 1 month post-dose, 3 months post-dose and 6 months post-dose\r\n** Prophylactic antiviral therapy may be initiated at the discretion of the investigator
HAPLO-IDENTICAL DONOR: Evidence of active infection (including active urinary tract infection, or upper respiratory tract infection) or evidence of viral hepatitis exposure on screening unless only hepatitis B surface antibody (HbsAB)+ and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) negative
Clinically active hepatitis B defined as positive hepatitis B surface antigen (HBsAg); or positive hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) viral load; patients who are HBcAb with undetectable HBV DNA viremia are eligible
DONOR: Evidence of active infection (including urinary tract infection, or upper respiratory tract infection) or viral hepatitis exposure (on screening), unless only hepatitis B surface antibody positive (Hbs Ab+) and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) negative
Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg) and a detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) viral load; if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of hepatitis B surface antibody [HBsAb] status), a HBV DNA test will be performed and if positive the subject will be excluded; if HBV DNA is negative, subject may be included but must undergo at least every 2-month HBV DNA polymerase chain reaction (PCR) testing from the start of treatment during the treatment course; prophylactic antiviral therapy may be initiated at the discretion of the investigator
Specific guidelines will be followed regarding inclusion of MCL based on hepatitis B serological testing as follows:\r\n* Hepatitis B surface antigen (HBsAg) negative, hepatitis B core antibody (HBcAb) negative, hepatitis B surface antibody (HBsAb) positive MCL patients are eligible\r\n* Patients who test positive for HBsAg are ineligible (regardless of other hepatitis B serologies)\r\n* For MCL patients with HBsAg negative, but HBcAb positive (regardless of HBsAb status), should have hepatitis B virus (HBV) deoxyribonucleic acid (DNA) testing done and protocol eligibility determined as follows:\r\n** If HBV DNA is positive the subject is excluded\r\n** If HBV DNA is negative, patient may be included but must undergo at least every 2 months HBV DNA polymerase chain reaction (PCR) testing from the start of treatment throughout the duration the study\r\n** Monitoring during the study is required at least every 2 months and during follow-up at a minimum of every 2-3 months up to 6 months after the last dose\r\n** Prophylactic antiviral therapy with lamivudine (3TC) or investigator’s preferred antiviral regimen throughout protocol therapy and for 6-12 months thereafter may be initiated at the discretion of the investigator\r\n** If the patients’ HBV DNA becomes positive during the study, the investigator should manage the clinical situation as per the standard of care of participating institution; the investigator should weigh the risks and benefits of continuing ofatumumab or discontinuing ofatumumab before appropriate treatment decisions are made for that individual patient
Participants with chronic hepatitis B or seropositive occult (HBV) infection
Participants with seronegative occult HBV infection or past HBV infection (defined as anti-HBc positive and HBV DNA negative) could be eligible if they were willing to be followed according to the protocol for HBV DNA testing
Chronic or active hepatitis B or C (patients positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA; patients positive for HCVAb will be eligible if negative for HCV-RNA)
Known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV), or hepatitis B or C virus (HBV, HCV). a. Hepatitis B screening is mandatory for all patients (HBsAg and anti-HBc). Patients with active hepatitis B disease should not be treated with obinutuzumab. Patients should be referred to a specialist if they are carriers before treatment starts (see PI or SmPC). Subjects who are positive for anti-HBc and/or anti-HBs but negative for HBsAg and HBV DNA may be treated after consultation with a hepatologist.
Participants with occult or prior hepatitis B virus (HBV) infection may be included if HBV deoxyribonucleic acid (DNA) is undetectable at screening. These participants must be willing to undergo monthly HBV DNA test until at least 12 months after the last treatment cycle
History of chronic hepatitis B virus (HBV) infection or positive test results for active or chronic HBV infection defined by hepatitis B surface antigen (HBsAg)
Active hepatitis B virus (HBV) defined by positive hepatitis B surface antigen (HBsAg) test at screening; patients with past or resolved HBV infection (defined by a negative HBsAg test and a positive anti-hepatitis B core antigen [anti-HBc] antibody test) are eligible; HBV deoxyribonucleic acid (DNA) must be obtained in these patients prior to first day of study treatment
Current treatment with anti-viral therapy for Hepatitis B Virus (HBV)
subjects with anti-hepatitis B core antibody but with undetectable HBV DNA and negative for HBsAg