Evidence map›Paper›PMID 28898281›Full record

Trial reportPloS one2017

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.

María Buti, María L Manzano, Rosa M Morillas, Montserrat García-Retortillo, Leticia Martín, Martín Prieto, María L Gutiérrez, Emilio Suárez, Mariano Gómez Rubio, Javier López and 8 more

Erratum issuedOpen access · goldAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 32 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 7 pooled it
9.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 7 syntheses or guidelines pooled it, 95 citations in OpenAlex.

  1. Pooled it
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  19. Adverse Effects of Immunosuppression: Infections.Handbook of experimental pharmacology · 2022
    Article
  20. Guidelines for Prevention and Treatment of Chronic Hepatitis B.Journal of clinical and translational hepatology · 2021
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 17 institutions in 1 country.

María ButiLiver Unit, Hospital Vall Hebron and CIBEREHD del Instituto Carlos III, Barcelona, Spain.
María L ManzanoDepartment of Hepatology, Hospital Doce de Octubre, Madrid, Spain.
Rosa M MorillasDepartment of Hepatology, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain.
Montserrat García-RetortilloDepartment of Hepatology, Hospital del Mar, Barcelona, Spain.
Leticia MartínDepartment of Hepatology, Hospital de Donostia, San Sebastián, Spain.
Martín PrietoDepartment of Hepatology, Hospital Universitario i Politécnico La Fe, Valencia, Spain.
María L GutiérrezDepartment of Hepatology, Fundación Hospital de Alcorcón, Madrid, Spain.
Emilio SuárezDepartment of Hepatology, Hospital Nuestra Señora de Valme, Seville, Spain.
Mariano Gómez RubioDepartment of Gastroenterology, Hospital de Getafe, Madrid, Spain.
Javier LópezDepartment of Hematology, Hospital Ramón y Cajal, Madrid, Spain.
Pilar CastilloDepartment of Hepatology, Hospital La Paz, Madrid, Spain.
Manuel RodríguezDepartment of Hepatology, Hospital Central de Asturias, Oviedo, Spain.
José M ZozayaDepartment of Gastroenterology, Hospital de Navarra, Pamplona, Spain.
Miguel A SimónDepartment of Hepatology, Hospital Clínico Lozano Blesa, Zaragoza, Spain.
Luis E MoranoDepartment of Infectious Diseases, Hospital do Meixoeiro, Vigo, Spain.
José L CallejaDepartment of Gastroenterology, Hospital Puerta de Hierro Majadahonda, Madrid, Spain.
María YébenesPharmacoeconomics & Outcomes Research Iberia, Madrid, Spain.ORCID http://orcid.org/0000-0001-9962-0901
Rafael EstebanLiver Unit, Hospital Vall Hebron and CIBEREHD del Instituto Carlos III, Barcelona, Spain.
Instituto de Salud Carlos III · ESBiogipuzkoa Health Research Institute · ESHospital Clínico Universitario Lozano Blesa · ESHospital Del Mar · ESHospital Universitari Germans Trias i Pujol · ESHospital Universitari i Politècnic La Fe · ESHospital Universitario 12 De Octubre · ESHospital Universitario Central de Asturias · ESHospital Universitario de Getafe · ESHospital Universitario de Valme · ESHospital Universitario Fundación Alcorcón · ESHospital Universitario La Paz · ESHospital Universitario Puerta de Hierro Majadahonda · ESHospital Universitario Ramón y Cajal · ESPharmacoeconomics and Health Outcomes Research Iberia (Spain) · ESUniversidad de Navarra · ESUniversity Hospital Complex Of Vigo · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHepatitis 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.

methodsPREBLIN 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.

resultsSixty-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.

conclusionIn patients with hematological malignancy and resolved hepatitis B infection receiving RTX-based regimens, HBV reactivation did not occur in patients given TDF prophylaxis.

Indexed as

AgedAged, 80 and overAntineoplastic AgentsAntiviral AgentsFemaleHepatitis BHepatitis B virusHumansLeukemiaMaleMiddle AgedPost-Exposure ProphylaxisRituximabSerologic TestsTenofovirAntineoplastic AgentsAntiviral AgentsRituximabTenofovir

Identifiers

PMID28898281
PMCPMC5595327
OpenAlexW2755293930

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.