Prevention of HBV reactivation in patients treated with biologic agents

Expert Review of Clinical Pharmacology

Volumn 9, Issue 4, 2016, Pages 579-589

  Koutsianas, Christos ^a,b   Thomas, Konstantinos ^a   Vassilopoulos, Dimitrios ^a  

^a UNIVERSITY OF ATHENS   (Greece)

^b RUSSELLS HALL HOSPITAL   (United Kingdom)

Author keywords

abatacept; biologic agents; Hepatitis B; hepatitis B virus; rituximab; tocilizumab; tumor necrosis factor inhibitors

Indexed keywords

ABATACEPT; ALANINE AMINOTRANSFERASE; CIRCULAR DNA; GAMMA INTERFERON; HEPATITIS B CORE ANTIBODY; HEPATITIS B SURFACE ANTIGEN; HEPATITIS B(E) ANTIGEN; HEPATITIS VACCINE; IMMUNOSUPPRESSIVE AGENT; RITUXIMAB; SECUKINUMAB; TOCILIZUMAB; TOFACITINIB; TUMOR NECROSIS FACTOR ALPHA; TUMOR NECROSIS FACTOR ALPHA INHIBITOR; USTEKINUMAB; VIRUS DNA;

ADAPTIVE IMMUNITY; ANTIVIRAL THERAPY; BIOLOGICAL THERAPY; CD8+ T LYMPHOCYTE; DISEASE SEVERITY; HEPATITIS B; HISTORY; HOSPITALIZATION; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; INFECTION PREVENTION; INFECTION RISK; INNATE IMMUNITY; LIVER CELL; LIVER CELL DAMAGE; LIVER FAILURE; MORBIDITY; MORTALITY; NATURAL KILLER CELL; NOMENCLATURE; NONHUMAN; PRACTICE GUIDELINE; PREVALENCE; REVIEW; VACCINATION; VIRUS GENOME; VIRUS REACTIVATION;

EID: 84958055062     PISSN: 17512433     EISSN: 17512441     Source Type: Journal    
DOI: 10.1586/17512433.2016.1143773     Document Type: Review

References (72)

1. Ott JJ, Stevens GA, Groeger J, et al. Global epidemiology of hepatitis B virus infection: new estimates of age-specific HBsAg seroprevalence and endemicity. Vaccine. 2012;30(12):2212-2219.
2. Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380 (9859):2095-2128.
3. Ioannou GN. Hepatitis B virus in the United States: infection, exposure, and immunity rates in a nationally representative survey. Ann Intern Med. 2011;154(5):319-328.
4. Cross M, Smith E, Hoy D, et al. The global burden of rheumatoid arthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014;73 (7):1316-1322.
5. Dean LE, Jones GT, MacDonald AG, et al. Global prevalence of ankylosing spondylitis. Rheumatology (Oxford). 2014;53(4):650-657.
6. Dougados M, Soubrier M, Antunez A, et al. Prevalence of comorbidities in rheumatoid arthritis and evaluation of their monitoring: results of an international, cross-sectional study (COMORA). Ann Rheum Dis. 2014;73(1):62-68.
7. Molto A, Etcheto A, Van Der Heijde D, et al. Prevalence of comorbidities and evaluation of their screening in spondyloarthritis: results of the international cross-sectional ASAS-COMOSPA study. Ann Rheum Dis. 2015. doi:10.1136/annrheumdis-2015-208174. Published online 21 October 2015.
8. Urata Y, Uesato R, Tanaka D, et al. Prevalence of reactivation of hepatitis B virus replication in rheumatoid arthritis patients. Mod Rheumatol. 2011;21(1):16-23.
9. Mori S. Past hepatitis B virus infection in rheumatoid arthritis patients receiving biological and/or nonbiological disease-modifying antirheumatic drugs. Mod Rheumatol. 2011;21(6):621-627.
10. Vassilopoulos D, Apostolopoulou A, Hadziyannis E, et al. Long-term safety of anti-TNF treatment in patients with rheumatic diseases and chronic or resolved hepatitis B virus infection. Ann Rheum Dis. 2010;69(7):1352-1355.
11. Giardina AR, Ferraro D, Ciccia F, et al. No detection of occult HBV-DNA in patients with various rheumatic diseases treated with anti-TNF agents: a two-year prospective study. Clin Exp Rheumatol. 2013;31(1):25-30.
12. Trépo C, Chan HL, Lok A. Hepatitis B virus infection. Lancet. 2014;384(9959):2053-2063.
13. Hadziyannis SJ, Vassilopoulos D, Hadziyannis E. The natural course of chronic hepatitis B virus infection and its management. Adv Pharmacol. 2013;67:247-291.
14. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. J Hepatol. 2012;57(1):167-185.
15. Terrault NA, Bzowej NH, Chang KM, et al. AASLD guidelines for treatment of chronic hepatitis B. Hepatology 2016;63(1):261-283.
16. Simonetti J, Bulkow L, McMahon BJ, et al. Clearance of hepatitis B surface antigen and risk of hepatocellular carcinoma in a cohort chronically infected with hepatitis B virus. Hepatology. 2010;51(5):1531-1537.
17. Kato M, Atsumi T. Reactivation of occult hepatitis B virus infection in patients with rheumatic diseases: pathogenesis, risk assessment and prevention. Rheumatol Int. 2015. Published online 16 November 2015. [Epub ahead of print].
18. Squadrito G, Spinella R, Raimondo G. The clinical significance of occult HBV infection. Ann Gastroenterol. 2014;27(1):15-19.
19. Di Bisceglie AM, Lok AS, Martin P, et al. Recent US Food and Drug Administration warnings on hepatitis B reactivation with immune-suppressing and anticancer drugs: just the tip of the iceberg? Hepatology. 2015;61(2):703-711.
20. Hwang JP, Lok AS. Management of patients with hepatitis B who require immunosuppressive therapy. Nat Rev Gastroenterol Hepatol. 2014;11(4):209-219.
21. Hsu C, Tsou -H-H, Lin S-J, et al. Chemotherapy-induced hepatitis B reactivation in lymphoma patients with resolved HBV infection: a prospective study. Hepatology. 2014;59(6):2092-2100.
22. Chang M-L, Liaw Y-F. Hepatitis B flares in chronic hepatitis B: pathogenesis, natural course, and management. J Hepatol. 2014;61(6):1407-1417.
23. Yang HC, Kao JH. Persistence of hepatitis B virus covalently closed circular DNA in hepatocytes: molecular mechanisms and clinical significance. Emerg Microbes Infect. 2014;3(9):e64.
24. Bertoletti A, Ferrari C. Innate and adaptive immune responses in chronic hepatitis B virus infections: towards restoration of immune control of viral infection. Gut. 2012;61(12):1754-1764.
25. Phillips S, Chokshi S, Riva A, et al. CD8(+) T cell control of hepatitis B virus replication: direct comparison between cytolytic and noncytolytic functions. J Immunol. 2010;184(1):287-295.
26. Galbraith RM, Eddleston AL, Williams R, et al. Fulminant hepatic failure in leukaemia and choriocarcinoma related to withdrawal of cytotoxic drug therapy. Lancet. 1975;2 (7934):528-530.
27. Nagington J. Reactivation of hepatitis b after transplantation operations. Lancet. 1977;1(8011):558-560.
28. Paul S, Saxena A, Terrin N, et al. Hepatitis B virus reactivation and prophylaxis during solid tumor chemotherapy: a systematic review and meta-analysis. Ann Intern Med. 2016;164(1):30-40.
29. Vassilopoulos D, Calabrese LH. Management of rheumatic disease with comorbid HBV or HCV infection. Nat Rev Rheumatol. 2012;8(6):348-357.
30. Yeo W, Zee B, Zhong S, et al. Comprehensive analysis of risk factors associating with Hepatitis B virus (HBV) reactivation in cancer patients undergoing cytotoxic chemotherapy. Br J Cancer. 2004;90(7):1306-1311.
31. Shouval D, Shibolet O. Immunosuppression and HBV reactivation. Semin Liver Dis. 2013;33(2):167-177.
32. Perrillo RP, Gish R, Falck-Ytter YT. American Gastroenterological Association Institute technical review on prevention and treatment of hepatitis B virus reactivation during immunosuppressive drug therapy. Gastroenterology. 2015;148(1):221-244.
33. Reddy KR, Beavers KL, Hammond SP, et al. American Gastroenterological Association Institute guideline on the prevention and treatment of hepatitis B virus reactivation during immunosuppressive drug therapy. Gastroenterology. 2015;148(1):215-219.
34. Carroll MB, Forgione MA. Use of tumor necrosis factor alpha inhibitors in hepatitis B surface antigen-positive patients: a literature review and potential mechanisms of action. Clin Rheumatol. 2010;29(9):1021-1029.
35. Mori S, Fujiyama S. Hepatitis B virus reactivation associated with antirheumatic therapy: risk and prophylaxis recommendations. World J Gastroenterol. 2015;21 (36):10274-10289.
36. Calabrese LH, Zein N, Vassilopoulos D. Safety of antitumour necrosis factor (anti-TNF) therapy in patients with chronic viral infections: hepatitis C, hepatitis B, and HIV infection. Ann Rheum Dis. 2004;63(Suppl 2):ii18-24.
37. Perez-Alvarez R, Diaz-Lagares C, Garcia-Hernandez F, et al. Hepatitis B virus (HBV) reactivation in patients receiving tumor necrosis factor (TNF)-targeted therapy: analysis of 257 cases. Medicine (Baltimore). 2011;90 (6):359-371.
38. Tamori A, Koike T, Goto H, et al. Prospective study of reactivation of hepatitis B virus in patients with rheumatoid arthritis who received immunosuppressive therapy: evaluation of both HBsAg-positive and HBsAg-negative cohorts. J Gastroenterol. 2011;46(4):556-564.
39. Lan J-L, Chen Y-M, Hsieh T-Y, et al. Kinetics of viral loads and risk of hepatitis B virus reactivation in hepatitis B core antibody-positive rheumatoid arthritis patients undergoing anti-tumour necrosis factor alpha therapy. Ann Rheum Dis. 2011;70(10):1719-1725.
40. Lee YH, Bae S-C, Song GG. Hepatitis B virus reactivation in HBsAg-positive patients with rheumatic diseases undergoing anti-tumor necrosis factor therapy or DMARDs. Int J Rheum Dis. 2013;16(5):527-531.
41. Ryu HH, Lee EY, Shin K, et al. Hepatitis B virus reactivation in rheumatoid arthritis and ankylosing spondylitis patients treated with anti-TNFalpha agents: a retrospective analysis of 49 cases. Clin Rheumatol. 2012;31 (6):931-936.
42. Nakamura J, Nagashima T, Nagatani K, et al. Reactivation of hepatitis B virus in rheumatoid arthritis patients treated with biological disease-modifying antirheumatic drugs. Int J Rheum Dis. 2014. doi:10.1111/1756-185X.12359. Published online 4 April 2014.
43. Ye H, Zhang XW, Mu R, et al. Anti-TNF therapy in patients with HBV infection-analysis of 87 patients with inflammatory arthritis. Clin Rheumatol. 2014;33(1):119-123.
44. Papa A, Felice C, Marzo M, et al. Prevalence and natural history of hepatitis B and C infections in a large population of IBD patients treated with anti-tumor necrosis factor-alpha agents. J Crohns Colitis. 2013;7(2):113-119.
45. Cantini F, Boccia S, Goletti D, et al. HBV reactivation in patients treated with antitumor necrosis factor-alpha (TNF-alpha) agents for rheumatic and dermatologic conditions: a systematic review and meta-analysis. Int J Rheumatol. 2014;2014(926836):1-9.
46. Lee YH, Bae SC, Song GG. Hepatitis B virus (HBV) reactivation in rheumatic patients with hepatitis core antigen (HBV occult carriers) undergoing anti-tumor necrosis factor therapy. Clin Exp Rheumatol. 2013;31(1):118-121.
47. Barone M, Notarnicola A, Lopalco G, et al. Safety of longterm biologic therapy in rheumatologic patients with a previously resolved hepatitis B viral infection. Hepatology. 2015;62(1):40-46.
48. Artz AS, Somerfield MR, Feld JJ, et al. American Society of Clinical Oncology provisional clinical opinion: chronic hepatitis B virus infection screening in patients receiving cytotoxic chemotherapy for treatment of malignant diseases. J Clin Oncol. 2010;28(19):3199-3202.
49. Pei S-N, Ma M-C, Wang M-C, et al. Analysis of hepatitis B surface antibody titers in B cell lymphoma patients after rituximab therapy. Ann Hematol. 2012;91(7):1007-1012.
50. Seto W-K, Chan TS, Hwang YY, et al. Hepatitis B reactivation in patients with previous hepatitis B virus exposure undergoing rituximab-containing chemotherapy for lymphoma: a prospective study. J Clin Oncol. 2014;32 (33):3736-3743.
51. Mitka M. FDA: Increased HBV reactivation risk with ofatumumab or rituximab. JAMA. 2013;310(16):1664.
52. Mitroulis I, Hatzara C, Kandili A, et al. Long-term safety of rituximab in patients with rheumatic diseases and chronic or resolved hepatitis B virus infection. Ann Rheum Dis. 2013;72(2):308-310.
53. Van Vollenhoven RF, Fleischmann RM, Furst DE, et al. Long-term safety of rituximab: final report of the rheumatoid arthritis global clinical trial program over 11 years. J Rheumatol. 2015;42(10):1761-1766.
54. Nagashima T, Minota S. Long-term tocilizumab therapy in a patient with rheumatoid arthritis and chronic hepatitis B. Rheumatology (Oxford). 2008;47(12):1838-1840.
55. Kishida D, Okuda Y, Onishi M, et al. Successful tocilizumab treatment in a patient with adult-onset Still's disease complicated by chronic active hepatitis B and amyloid A amyloidosis. Mod Rheumatol. 2011;21(2):215-218.
56. Tsuboi H, Tsujii A, Nampei A, et al. A patient with rheumatoid arthritis treated with tocilizumab together with lamivudine prophylaxis after remission of infliximab-reactivated hepatitis B. Mod Rheumatol. 2011;21(6):701-705.
57. Kim PS, Ho GY, Prete PE, et al. Safety and efficacy of abatacept in eight rheumatoid arthritis patients with chronic hepatitis B. Arthritis Care Res (Hoboken). 2012;64(8):1265-1268.
58. Padovan M, Filippini M, Tincani A, et al. Safety of abatacept in rheumatoid arthritis with serological evidence of past or present hepatitis B virus infection. Arthritis Care Res (Hoboken). 2015. doi:10.1002/acr.22786. Published online 10 November 2015.
59. Fanouriakis A, Vassilopoulos D, Repa A, et al. Hepatitis B reactivation following treatment with abatacept in a patient with past hepatitis B virus infection. Rheumatology (Oxford). 2014;53(1):195-196.
60. Germanidis G, Hytiroglou P, Zakalka M, et al. Reactivation of occult hepatitis B virus infection, following treatment of refractory rheumatoid arthritis with abatacept. J Hepatol. 2012;56(6):1420-1421.
61. Navarro R, Vilarrasa E, Herranz P, et al. Safety and effectiveness of ustekinumab and antitumour necrosis factor therapy in patients with psoriasis and chronic viral hepatitis B or C: a retrospective, multicentre study in a clinical setting. Br J Dermatol. 2013;168(3):609-616.
62. Chiu H-Y, Chen C-H, Wu M-S, et al. The safety profile of ustekinumab in the treatment of patients with psoriasis and concurrent hepatitis B or C. Br J Dermatol. 2013;169 (6):1295-1303.
63. Lai GM, Yan SL, Chang CS, et al. Hepatitis B reactivation in chronic myeloid leukemia patients receiving tyrosine kinase inhibitor. World J Gastroenterol. 2013;19(8):1318-1321.
64. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American college of rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol. 2016;68(1):1-26.
65. Furst DE, Keystone EC, So AK, et al. Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2012. Ann Rheum Dis. 2013;72 (Suppl 2):ii2-34.
66. Motaparthi K, Stanisic V, Van Voorhees AS, et al. From the Medical Board of the National Psoriasis Foundation: recommendations for screening for hepatitis B infection prior to initiating anti-tumor necrosis factor-alfa inhibitors or other immunosuppressive agents in patients with psoriasis. J Am Acad Dermatol. 2014;70(1):178-186.
67. Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology. 2009;50(3):661-662.
68. Sarin SK, Kumar M, Lau GK, et al. Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update. Hepatol Int. 2016;10(1):1-98.
69. Huang YH, Hsiao LT, Hong YC, et al. Randomized controlled trial of entecavir prophylaxis for rituximab-associated hepatitis B virus reactivation in patients with lymphoma and resolved hepatitis B. J Clin Oncol. 2013;31(22):2765-2772.
70. Chen FW, Coyle L, Jones BE, et al. Entecavir versus lamivudine for hepatitis B prophylaxis in patients with haematological disease. Liver Int. 2013;33 (8):1203-1210.
71. Li HR, Huang JJ, Guo HQ, et al. Comparison of entecavir and lamivudine in preventing hepatitis B reactivation in lymphoma patients during chemotherapy. J Viral Hepat. 2011;18(12):877-883.
72. Huang H, Li X, Zhu J, et al. Entecavir vs lamivudine for prevention of hepatitis B virus reactivation among patients with untreated diffuse large B-cell lymphoma receiving R-CHOP chemotherapy: a randomized clinical trial. JAMA. 2014;312(23):2521-2530.