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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
Buti, María (Hospital de la Vall d'Hebron)
Manzano,María L. (Hospital Doce de Octubre)
Morillas, Rosa M. (Institut Germans Trias i Pujol. Hospital Germans Trias i Pujol)
García-Retortillo, Montserrat (Hospital del Mar)
Martín, Leticia (Hospital de Donostia)
Prieto, Martín (Hospital Universitario y Politécnico La Fe)
Gutiérrez, María L. (Fundación Hospital de Alcorcón)
Suárez, Emilio (Hospital Nuestra Señora de Balme)
Gómez Rubio, Mariano (Hsopital de Getafe)
López,Javier (Hospital Ramón y Cajal)
Castillo, Pilar (Hospital La Paz)
Rodríguez,Manuel (Hospital Central de Asturias)
Zozaya, José M. (Hospital de Navarra)
Simón, Miguel A. (Hospital Clínico Lozano Blesa)
Morano,Luis E. (Hospital do Meixoeiro)
Calleja, José L. (Hospital Puerta de Hierro)
Yébenes María (Pharmacoeconomics & Outcomes Research Iberia)
Esteban, Rafael (Hospital de la Vall d'Hebron)

Fecha: 2017
Resumen: 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. Patientswith 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 RTXbased regimens, HBV reactivation did not occur in patients given TDF prophylaxis.
Derechos: Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original. Creative Commons
Lengua: Anglès.
Documento: article ; recerca ; publishedVersion
Publicado en: Plos one, Vol. 12 Núm. 9 (september 2017) , p. 1-14

DOI: https://doi.org/10.1371/journal.pone.0184550


14 p, 1.6 MB

El registro aparece en las colecciones:
Documentos de investigación > Documentos de los grupos de investigación de la UAB > Centros y grupos de investigación (producción científica) > Ciencias de la salud y biociencias > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Artículos > Artículos de investigación
Artículos > Artículos publicados

 Registro creado el 2018-10-26, última modificación el 2019-09-04



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