Randomized prospective study evaluating tenofovir disoproxil fumarate prophylaxis against hepatitis B virus reactivation in anti-HBc-positive patients with rituximab-based regimens to treat hematologic malignancies: The Preblin study

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  • dc.contributor.author Buti, Maríaca
  • dc.contributor.author Manzano, María L.ca
  • dc.contributor.author Morillas, Rosa M.ca
  • dc.contributor.author García-Retortillo, Montserratca
  • dc.contributor.author Martín, Leticiaca
  • dc.contributor.author Prieto, Martínca
  • dc.contributor.author Gutiérrez, María L.ca
  • dc.contributor.author Suárez, Emilioca
  • dc.contributor.author Gómez Rubio, Marianoca
  • dc.contributor.author López, Javierca
  • dc.contributor.author Castillo, Pilarca
  • dc.contributor.author Rodríguez, Manuelca
  • dc.contributor.author Zozaya, José M.ca
  • dc.contributor.author Simón, Miguel A.ca
  • dc.contributor.author Morano, Luis E.ca
  • dc.contributor.author Calleja, Jose Luisca
  • dc.contributor.author Yébenes, Maríaca
  • dc.contributor.author Esteban, Rafaelca
  • dc.date.accessioned 2018-07-18T08:05:22Z
  • dc.date.available 2018-07-18T08:05:22Z
  • dc.date.issued 2017
  • dc.description.abstract BACKGROUND: Hepatitis B virus (HBV) reactivation in patients with resolved HBV infection (HBsAg negative, antiHBc positive) is uncommon, but potentially fatal. The role of HBV prophylaxis in this setting is uncertain. The aim of this study was to compare the efficacy of tenofovir disoproxil fumarate (TDF) prophylaxis versus close monitoring in antiHBc-positive, HBsAg-negative patients under treatment with rituximab (RTX)-based regimens for hematologic malignancy. METHODS: PREBLIN is a phase IV, randomized, prospective, open-label, multicenter, parallel-group trial conducted in 17 hospitals throughout Spain. Anti-HBc-positive, HBsAg-negative patients with undetectable HBV DNA were randomized to receive TDF 300 mg once daily (Group I) or observation (Group II). The primary endpoint was the percentage of patients showing HBV reactivation during 18 months following initiation of RTX treatment. Patients with detectable HBV DNA (Group III) received the same dose of TDF and were analyzed together with Group I to investigate TDF safety. RESULTS: Sixty-one patients were enrolled in the study, 33 in the TDF treatment group and 28 in the observation group. By ITT analysis, HBV reactivation was 0% (0/33) in the study group and 10.7% (3/28) in the observation group (p = 0.091). None of the patients in either group showed significant differences in liver function parameters between baseline and the last follow-up sample. TDF was generally well tolerated and there were no severe treatment-related adverse events. CONCLUSION: In patients with hematological malignancy and resolved hepatitis B infection receiving RTX-based regimens, HBV reactivation did not occur in patients given TDF prophylaxis.
  • dc.format.mimetype application/pdf
  • dc.identifier.citation Buti M, Manzano ML, Morillas RM, García-Retortillo M, Martín L, Prieto M. et al. Randomized prospective study evaluating tenofovir disoproxil fumarate prophylaxis againsthepatitis B virus reactivation in anti-HBc-positive patients with rituximab-based regimens to treat hematologic malignancies: The Preblin study. PLoS One. 2017 Sep 12;12(9):e0184550. DOI: 10.1371/journal.pone.0184550
  • dc.identifier.doi http://dx.doi.org/10.1371/journal.pone.0184550
  • dc.identifier.issn 1932-6203
  • dc.identifier.uri http://hdl.handle.net/10230/35190
  • dc.language.iso eng
  • dc.publisher Public Library of Science (PLoS)ca
  • dc.relation.ispartof PLoS One. 2017 Sep 12;12(9):e0184550
  • dc.rights Copyright © 2017 Buti et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
  • dc.rights.accessRights info:eu-repo/semantics/openAccess
  • dc.rights.uri http://creativecommons.org/licenses/by/4.0/
  • dc.subject.other Hepatitis B -- Tractament
  • dc.title Randomized prospective study evaluating tenofovir disoproxil fumarate prophylaxis against hepatitis B virus reactivation in anti-HBc-positive patients with rituximab-based regimens to treat hematologic malignancies: The Preblin studyca
  • dc.type info:eu-repo/semantics/article
  • dc.type.version info:eu-repo/semantics/publishedVersion

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