Impaired anti-HBV vaccine response in non-cirrhotic chronic HCV is not overcome by double dose regimen: randomized control trial

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article
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2023
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ELSEVIER ESPANA
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ANNALS OF HEPATOLOGY, v.28, n.2, article ID 100891, 6p, 2023
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Introduction and Objectives: Some studies suggest chronic HCV infection diminishes responses to the antiHBV vaccine. We evaluated the efficacy of double versus standard dose HBV vaccination among HCV patients without cirrhosis.Patients and Methods: 141 adults with untreated chronic HCV were randomized to HBV vaccination with double dose (40 mu g) or standard dose (20 mu g) at 0,1 and 6 months; 70 healthy HCV-negative patients given standard dose served as controls. Vaccine response was defined by anti-HBs >= 10 mIU/mL.Results: 128 patients (60 double, 68 standard doses) completed the study. Patients were of median age 52 years, 61% female, 60% fibrosis <2 of 4, and 76% genotype 1 with median 6-log 10 IU/mL HCV RNA. Overall seroprotection rate was 76.7% (95% CI: 65-87) in the 40 mu g versus 73.5% (95% CI: 63-84) in the 20 mu g dose HCV-positive groups (p =0.68) and 91.2% (95%CI:84-99) in HCV-negative controls (p =0.011 and 0.003, respectively). In multivariate logistic regression, vaccine dose (double vs. standard dose) was not associated with vaccine response (OR=0.63, p =0.33). Of 32 HCV-infected patients who were non-responders to 3- doses, 25 received the fourth dose of vaccine. The fourth dose seroconversion rate for the 40 mu g and 20 mu g groups were 45.5% and 21.4%, respectively.Conclusions: In HCV-infected patients without cirrhosis, impaired responses to HBV vaccination cannot be overcome by the use of double dose HBV vaccination, but adding a fourth dose of vaccine for non-responders may be an effective strategy. Other adjuvant measures are needed to enhance seroconversion rates in these patients. Trial register: U 1111-1264-2343 (www.ensaiosclinicos.gov.br)(c) 2022 Fundacion Clinica Medica Sur, A.C.
Palavras-chave
Seroprotection, Fibrosis, Immunization, Prevention
Referências
  1. AASLD-IDSA Hepatitis C Guidance, 2020, HEPATOLOGY, V71, P686, DOI 10.1002/hep.31060
  2. Abbot, 2008, ARCH SYST ANT HBS PA
  3. Abbott, 2008, ABB REAL TIM HCV ASS
  4. Aggeletopoulou I, 2017, REV MED VIROL, V27, DOI 10.1002/rmv.1942
  5. ALS Andrade, 1997, METODOS INVESTIGACAO
  6. [Anonymous], 2017, GLOB HEP REP
  7. [Anonymous], 2016, GLOB HLTH SECT STRAT
  8. [Anonymous], 2019, WHAT IS HEP Q A
  9. Arslan M, 2001, LIVER TRANSPLANT, V7, P314, DOI 10.1053/jlts.2001.23069
  10. Ashhab AA, 2020, PLOS ONE, V15, DOI 10.1371/journal.pone.0237398
  11. Bonazzi PR, 2008, BRAZ J INFECT DIS, V12, P306, DOI 10.1590/S1413-86702008000400009
  12. Buxton JA, 2008, CAN J INFECT DIS MED, V19, P197, DOI 10.1155/2008/410362
  13. Chen DS, 2009, J HEPATOL, V50, P805, DOI 10.1016/j.jhep.2009.01.002
  14. Chu CM, 1999, GUT, V45, P613, DOI 10.1136/gut.45.4.613
  15. Das K, 2003, WORLD J GASTROENTERO, V9, P1132
  16. Harris AM, 2019, VACCINE, V37, P2188, DOI 10.1016/j.vaccine.2019.03.012
  17. Heffernan A, 2019, LANCET, V393, P1319, DOI 10.1016/S0140-6736(18)32277-3
  18. Idilman R, 2002, AM J GASTROENTEROL, V97, P435, DOI 10.1111/j.1572-0241.2002.05482.x
  19. Konstantinou D, 2015, ANN GASTROENTEROL, V28, P221
  20. Kramer ES, 2009, DIGEST DIS SCI, V54, P2016, DOI 10.1007/s10620-009-0867-4
  21. Krawczyk A, 2014, VACCINE, V32, P5077, DOI 10.1016/j.vaccine.2014.06.076
  22. Leroux-Roels G, 2011, CLIN VACCINE IMMUNOL, V18, P1510, DOI 10.1128/CVI.00539-10
  23. Leuridan E, 2011, CLIN INFECT DIS, V53, P68, DOI 10.1093/cid/cir270
  24. Maqsood MH, 2020, GASTROENTEROL REP, V8, P326, DOI 10.1093/gastro/goaa024
  25. Martins RM, 2004, MEM I OSWALDO CRUZ, V99, P865, DOI 10.1590/S0074-02762004000800014
  26. Missiha SB, 2008, GASTROENTEROLOGY, V134, P1699, DOI 10.1053/j.gastro.2008.02.069
  27. Moorman JP, 2011, VACCINE, V29, P3169, DOI 10.1016/j.vaccine.2011.02.052
  28. Moraes JC, IMMUNOGENICITY BRAZI
  29. Pan LP, 2014, HUM MOL GENET, V23, P2210, DOI 10.1093/hmg/ddt586
  30. Pawlotsky JM, 2020, J HEPATOL, V73, P1170, DOI 10.1016/j.jhep.2020.08.018
  31. Polaris Observatory HCV Collaborators, 2022, LANCET GASTROENTEROL, V7, P396, DOI 10.1016/S2468-1253(21)00472-6
  32. Polaris Observatory HCV Collaborators, 2015, GLOB PREV GEN DISTR
  33. Schillie S, 2018, MMWR-MORBID MORTAL W, V67, P455, DOI 10.15585/mmwr.mm6715a5
  34. Shi L, 2014, J IMMUNOL, V192, P649, DOI 10.4049/jimmunol.1302069
  35. Shive CL, 2018, VACCINE, V36, P453, DOI 10.1016/j.vaccine.2017.12.018
  36. Stroffolini T, 2019, DIGEST LIVER DIS, V51, P434, DOI 10.1016/j.dld.2018.09.010
  37. Vesikari T, 2021, JAMA NETW OPEN, V4, DOI 10.1001/jamanetworkopen.2021.28652
  38. Wang JM, 2013, VACCINE, V31, P2238, DOI 10.1016/j.vaccine.2013.03.003
  39. Zuckerman JN, 2001, HEPATOLOGY, V34, P798, DOI 10.1053/jhep.2001.27564