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, Maria (Hospital Universitari Vall d'Hebron)
Manzano, María L. (Hospital Universitario 12 de Octubre (Madrid))
Morillas Cunill, Rosa Ma. (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
García-Retortillo, Montserrat (Hospital del Mar (Barcelona, Catalunya))
Martín, Leticia (Hospital Universitario de Donostia (Sant Sebastià, País Basc))
Prieto, Martín (Hospital Universitari i Politècnic La Fe (València))
Gutiérrez-García, María-Luisa (Hospital Universitario Fundación Alcorcón)
Suárez, Emilio (Hospital Universitario Virgen de Valme (Sevilla, Andalusia))
Gómez Rubio, Mariano (Hospital Universitario de Getafe (Madrid))
López, Javier (Hospital Universitario Ramón y Cajal (Madrid))
Castillo, Pilar (Hospital Universitario La Paz (Madrid))
Rodríguez, Manuel (Hospital Universitario Central de Asturias)
Zozaya, José M. (Complejo Hospitalario de Navarra)
Simón, Miguel A. (Hospital Clínico Universitario "Lozano Blesa" de Zaragoza)
Morano Amado, Luis Enrique (Hospital do Meixoeiro)
Calleja, Jose Luis (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Yébenes, María (Pharmacoeconomics & Outcomes Research Iberia)
Esteban, Rafael (Esteban Mur) (Hospital Universitari Vall d'Hebron)

Data:	2017
Resum:	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.
Drets:	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.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	PloS one, Vol. 12 Núm. 9 (september 2017) , p. 1-14, ISSN 1932-6203

DOI: 10.1371/journal.pone.0184550
PMID: 28898281

14 p, 1.6 MB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
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