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 months
Active infection with hepatitis B virus (HBV) (positive hepatitis B surface antigen); HCV is allowed only in HCC participants. HCC participants at risk for HBV reactivation (as defined by anti-hepatitis B core antibody positive) are only eligible in the HCC cohort.
History of hepatitis B (HBV) with surface antigen (HBsAg) positivity within months prior to the date of informed consent for this study (if no test has been performed within months, it must be done at screening);
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 months after completion of therapy.
Confirmed positive test results for human immunodeficiency virus (HIV), or participants with chronic or active hepatitis B or C. Participants who have a history of hepatitis B or C who have undetectable HBV DNA or HCV RNA after anti-viral therapy may be enrolled.
Patients are not eligible who have clinically active hepatitis B (tested at screening) or known hepatitis A or C infections;\r\n* NOTE: Patients with chronic hepatitis C virus (HCV) or hepatitis B virus (HBV) infection may enroll if other laboratory criteria are met; those with HBV surface antigen positivity may enroll only if maintained on appropriate suppressive antiviral therapy, per treating investigators discretion, for the duration of enrollment in the trial
Negative hepatitis B surface antigen (HBsAg) and undetectable hepatitis B virus (HBV) DNA
HBV and HVC co-infection, or HBV and Hep D co-infection
HBV surface antigen (HBsAg) positive
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 days prior to CD: Hepatitis B virus (HBV) surface antigen negative
Obtained within days prior to CD: HBV surface antibody positive or negative
Obtained within days prior to CD: HBV core antibody negative\r\n* Subjects whose HBV core antibody is positive must have a negative HBV viral load measurement
Suppression of hepatitis B (HBV) (=< 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 < IU/mL; if active HBV, subjects must be on anti-viral medication for >= 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 < 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
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 CD prior to or at the time of lymphoma diagnosis < cells/mm^.\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 months following the completion of therapy or until the CD cells recover to over cells/mm^, whichever occurs later.
Subjects are eligible to enroll if they have non-viral-HCC, or if they have hepatitis B virus (HBV)HCC, or hepatitis C virus (HCV)-HCC defined as follows:\r\n* HBV-HCC: 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 weeks and HBV viral load must be less than IU/mL prior to first dose of study drug. Subjects on active HBV therapy with viral loads under IU/ml should stay on the same therapy throughout study treatment. Subjects who are hepatitis B virus core antibody (anti-HBc) (+), negative for hepatitis B surface antigen (HBsAg), negative for hepatitis B virus surface antibody (anti-HBs), and have an HBV viral load under IU/mL do not require HBV anti-viral prophylaxis\r\n*** HCV-HCC: active or resolved HCV infection as evidenced by detectable HCV ribonucleic acid (RNA) or antibody. Patients who have failed HCV therapy as evidenced by detectable HCV RNA will be eligible. Subjects with chronic infection by HCV who are treated (successfully or treatment failure) or untreated are allowed on study. In addition, subjects with successful HCV treatment are allowed as long as there are >= weeks between completion of HCV therapy and start of study drug. Successful HCV treatment definition: SVR
Viral status (hepatitis B and C) must be known. All hepatitis B virus (HBV)-positive patients must be on antiviral medication for viral suppression.\r\n* Patients with concomitant HBV infection must have a confirmed diagnosis of HBV characterized by the presence of hepatitis B core antibodies, and be sufficiently suppressed with active antiviral treatment (per local institutional practice) prior to enrollment to ensure adequate viral suppression (HBV deoxyribonucleic acid [DNA] < IU/mL).\r\n* Patients with concomitant hepatitis C virus (HCV) infection must have confirmed diagnosis of HCV characterized by the presence of detectable HCV ribonucleic acid (RNA or anti-HCV antibody upon enrollment.
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 IU/mL
Active coinfection with HBV plus hepatitis delta (D) virus (HDV) or HCV:\r\n* Both hepatitis B and C as evidenced by detectable HBV surface antigen or HBV DNA and detectable HCV ribonucleic acid (RNA)\r\n* Hepatitis D infection (HDV antibody positive) in subjects with detectable hepatitis B surface antigen or HBV DNA
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 months screening. Hepatitis B or C testing is not required.
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) < 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 months, and HBV viral load must be less than IU/mL prior to first dose of stud drug; those on active HBV therapy with viral loads under 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 IU/mL do not require HBV anti-viral prophylaxis, but need close monitoring
If positive for hepatitis B virus (HBV) exposure or prior infection, can continue to participate in trial with prophylactic entecavir (for HBV); if positive for hepatitis C virus (HCV) exposure or active infection, can participate in trial with monitoring for liver function abnormalities
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.
Uncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the patient at the discretion of the investigator:\r\n* Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia\r\n* Uncontrolled and/or symptomatic thyroid disease\r\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within weeks prior to cycle , day ;\r\n* Known infection with human T-cell leukemia virus (HTLV-)\r\n* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis; as well as active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV):\r\n** Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation\r\n** Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody [HBcAb] and negative hepatitis B surface antigen [HBsAg]) may be included if HBV DNA is undetectable; these patients must be willing to undergo monthly DNA testing during treatment and for at least months after completion of study therapy\r\n* Malabsorption syndrome or other condition that precludes enteral route of administration\r\n* Psychiatric illness/social situations that would limit compliance with study requirements
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 weeks and HBV viral load must be less than IU/mL prior to first dose of study drug; subjects on active HBV therapy with viral loads under 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 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 >= weeks between achieving sustained viral response (SVR) and start of study drug
Hepatitis B virus (HBV) positive participants will be excluded
Patients with human immunodeficiency virus (HIV) are eligible for the study provided they meet the other protocol criteria in addition to the following: \r\n* Undetectable HIV load by standard polymerase chain reaction (PCR) clinical assay\r\n* Absolute CD count of >= mm^\r\n* Willing to maintain adherence to combination antiretroviral therapy\r\n* No history of acquired immunodeficiency syndrome (AIDS) defining condition (other than lymphoma or CD cell count < mm^)\r\n* Likely to have near normal lifespan if not for the presence of relapsed/refractory lymphoma\r\n**Patients with evidence of hepatitis B virus (HBV) are eligible provided there is minimal hepatic injury and the patient has undetectable HBV on suppressive HBV therapy; patient must be willing to maintain adherence to HBV therapy\r\n** Patients with previously treated and eradicated hepatitis C virus (HCV) who have minimal hepatic injury are eligible
Confirmed positive test results for human immunodeficiency virus (HIV), or participants with chronic or active hepatitis B or C. Subjects who have a history of hepatitis B or C who have undetectable HBV DNA or HCV RNA are anti-viral therapy may be enrolled.
Has untreated active hepatitis B; Note: to qualify for enrollment, antiviral therapy for HBV must be given for at least months prior to first dose of study drug, and HBV viral load must be less than IU/mL prior to first dose of study drug; those on active HBV therapy with viral loads under 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 < 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
Hepatitis B virus (HBV) surface-antigen positive unless receiving both tenofovir and lamivudine as part of antiretroviral therapy if HIV-infected
Note - Subjects with a history of hepatitis B or C with normal ALT and undetectable HBV DNA or HCV RNA are eligible for this study
For HCC with prior hepatitis B and/or C infection, HBV and/or HCV viral load by real-time polymerase chain reaction (qPCR) must be undetectable, and they must not have had recent treatment within weeks for HBV or HCV with certain antiviral medications.
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
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
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
Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with copanlisib or nivolumab\r\n* Patients with human immunodeficiency virus (HIV): HIV-positive patients on combination antiretroviral therapy are ineligible; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated; patients with evidence of hepatitis B virus (HBV) are eligible provided there is minimal hepatic injury and the patient has undetectable HBV on suppressive HBV therapy; patient must be willing to maintain adherence to HBV therapy\r\n* Patients with previously treated and eradicated hepatitis C virus (HCV) who have minimal hepatic injury are eligible
HIV infection, active hepatitis B or C infection. History of treated hepatitis B or C is permitted if the viral load is undetectable. HCC patients with controlled or chronic stable HBV infection will be eligible for screening. HCC patients with HBV infections who are not on anti-HBV treatment will be excluded from the study. HCC subjects with HCV infections will be allowed for screening; however, subjects with both HBV and HCV infections will be excluded for screening
Hepatitis B (HBV) or hepatitis C (HCV); all patients must be screened for HBV and HCV up to days prior to study drug start using the routine hepatitis virus laboratorial panel; patients with active HBV or hepatitis C infection are not eligible for enrollment; patients with serologic markers of HBV immunization due to known vaccination (hepatitis B surface antigen [HBsAg] negative, anti-hepatitis B core [HBc] negative and anti-hepatitis B surface [HBs] positive) will be eligible
DONOR: HIV seropositivity or presence of HBV deoxyribonucleic acid (DNA) or HCV ribonucleic acid (RNA) in the serum
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 months for months post-treatment, while continuing lamivudine
Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.
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 < 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 CD and must be willing to continue antiviral therapy while on study treatment.
HIV, active hepatitis B (HBV) or active hepatitis C (HCV)\r\n* Patients with past HBV infection or resolved HBV infection, defined as the presence of hepatitis B core antibody (HBc Ab) and absence of hepatitis B surface antigen (HBsAg) are eligible; HBV deoxyribonucleic acid (DNA) must be obtained in these patients prior to day of ibrutinib therapy, but detection of HBV DNA in these patients will not exclude study participation\r\n* Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Patients testing positive to one of the following viruses: HIV, HBV and HCV within the last months;
Subjects who are seropositive because of HBV vaccination are eligible (HBV surface antibody positive, HBV core antibody negative, and HBV surface antigen negative)
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)
For Cohort : has dual active HBV infection (Hepatitis B surface antigen positive and/or detectable HBV deoxyribonucleic acid [DNA]) and HCV infection (detectable HCV ribonucleic acid [RNA]) at study entry
Subjects with active HBV infection need to be on anti-HBV suppression ? months, throughout treatment and for 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 - weeks prior to st dose of EGF treatment and continue on antiviral therapy for at least weeks after the last dose of EGF.
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
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 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 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
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
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
Active infection with HIV, HBV or HCV as defined below, due to the immunosuppressive effects of cyclophosphamide used and the unknown risks associated with viral replication.
Patients with chronic Hepatitis B and C infection. For patients with hepatocellular carcinoma (HCC), the presence of chronic HBV and HCV is NOT an exclusion. Patients must have a viral titer < IU/ml x at a minimum of weeks apart.
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
DONOR: Positive hepatitis B virus (HBV) PCR
Patients with active hepatitis B (HBV) (detectable HBV- deoxyribonucleic acid [DNA] or hepatitis B virus surface antigen [HBsAg] +) or hepatitis C (HCV) infection (detectable HCV ribonucleic acid [RNA] by polymerase chain reaction [PCR])
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 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)
Positive test for hepatitis B virus (HBV) surface antigen
RECIPIENT: Seronegative for HIV, HCV and active HBV (surface antigen negative) within months of registration
Are not aware of HBV infection
Current treatment with anti-viral therapy for Hepatitis B Virus (HBV)
NOTE: Patients with chronic hepatitis C virus (HCV) or hepatitis B virus (HBV) infection may enroll if other laboratory criteria are met; those with HBV surface antigen positivity may enroll only if maintained on appropriate suppressive antiviral therapy for the duration of enrollment in the trial