Evidence map›Paper›PMID 41335575›Full record

Trial reportHepatology communications2025

Tenofovir alafenamide for prevention of HBV reactivation in HBsAg-negative, anti-HBc-positive patients undergoing rituximab-based chemotherapy: A multicenter randomized controlled trial.

Sanam Tabataba Vakili, Grishma Hirode, Atif Zahoor, Ahreni Saunthar, Joshua B Feld, Bettina E Hansen, Ambreen Syeda, Harry L A Janssen, Vishal Kukreti, John Kuruvilla and 10 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Hepatology communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02186574 (A Multi-centre Phase III Study to Evaluate Pre-emptive Tenofovir for Prevention of Hepatitis B Virus Reactivation in HBsAg Negative/Anti-HBc Positive Individuals Undergoing Anti-CD20-based Chemotherapy for Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT02186574 phase3unknown statusnot on this map

A Multi-centre Phase III Study to Evaluate Pre-emptive Tenofovir for Prevention of Hepatitis B Virus Reactivation in HBsAg Negative/Anti-HBc Positive Individuals Undergoing Anti-CD20-based Chemotherapy for Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia

TypeinterventionalSponsorUniversity Health Network, TorontoRan2015 to 2021Enrolled184ConditionsHepatitis B, Lymphoma, Non-HodgkinArmsTenofovir disoproxil, Placebo Oral Tablet
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Sanam Tabataba VakiliToronto Centre for Liver Disease, University Health Network, Toronto, Ontario, Canada.ORCID 0009-0001-7422-5398
Grishma HirodeToronto Centre for Liver Disease, University Health Network, Toronto, Ontario, Canada.ORCID 0000-0003-1530-5950
Atif ZahoorToronto Centre for Liver Disease, University Health Network, Toronto, Ontario, Canada.
Ahreni SauntharToronto Centre for Liver Disease, University Health Network, Toronto, Ontario, Canada.
Joshua B FeldToronto Centre for Liver Disease, University Health Network, Toronto, Ontario, Canada.
Bettina E HansenToronto Centre for Liver Disease, University Health Network, Toronto, Ontario, Canada.ORCID 0000-0001-8307-3341
Ambreen SyedaToronto Centre for Liver Disease, University Health Network, Toronto, Ontario, Canada.
Harry L A JanssenToronto Centre for Liver Disease, University Health Network, Toronto, Ontario, Canada.ORCID 0000-0003-2398-8392
Vishal KukretiPrincess Margaret Cancer Centre, Toronto, Ontario, Canada.
John KuruvillaPrincess Margaret Cancer Centre, Toronto, Ontario, Canada.
Anca PricaPrincess Margaret Cancer Centre, Toronto, Ontario, Canada.
Matthew CheungSunnybrook Odette Cancer Centre, University of Toronto, Toronto, Ontario, Canada.
Rena BucksteinSunnybrook Odette Cancer Centre, University of Toronto, Toronto, Ontario, Canada.
Lisa HicksDivision of Hematology and Oncology, St. Michael's Hospital, Toronto, Ontario, Canada.
Carla S CoffinDivision of Gastroenterology and Hepatology, Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.ORCID 0000-0002-1472-0901
Lesley E StreetDivision of Hematology and Hematologic Malignancies, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Patricia DisperatiMichael Garron Hospital, Toronto, Ontario, Canada.
Kelvin K ChanSunnybrook Odette Cancer Centre, University of Toronto, Toronto, Ontario, Canada.
Michael CrumpPrincess Margaret Cancer Centre, Toronto, Ontario, Canada.
Jordan J FeldToronto Centre for Liver Disease, University Health Network, Toronto, Ontario, Canada.ORCID 0000-0003-2640-2211

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsImmunosuppression can cause hepatitis B virus (HBV) reactivation, leading to severe outcomes in patients with "resolved" HBV infection. This multicenter, randomized, placebo-controlled trial assessed the efficacy of preemptive antiviral therapy in HBsAg-negative, anti-HBc-positive patients receiving rituximab-based chemotherapy for non-Hodgkin lymphoma (NHL).

methodsPatients were randomized 1:1 to tenofovir alafenamide (TAF)/placebo across 3 phases: chemotherapy plus TAF/placebo (phase 1), TAF/placebo post-chemotherapy (phase 2), and follow-up after therapy cessation (phase 3). The primary endpoint was HBsAg reverse seroconversion. HBsAg and ALT were monitored every 3-12 weeks, depending on treatment phase, and HBV DNA was measured post hoc. ClinicalTrials.gov (NCT02186574).

resultsAmong 42 patients (median age 65.2 years, 52.4% male, 52.4% aggressive lymphoma, 73.8% anti-HBs positive), 20 received TAF and 22 received a placebo. Median ALT was 20.0 U/L (IQR: 15.0-28.0) at baseline. Median follow-up was 69.4 weeks (IQR: 63.7-166), with 6.1 weeks (IQR: 4.7-8.3) between visits. During follow-up, 2 patients in the TAF arm, but none receiving placebo, experienced HBsAg reverse seroconversions: occurring in phase 3 at 62.3 weeks from baseline, and in phase 1 at 20.0 weeks from baseline. Neither patient experienced ALT >2× ULN. HBV DNA >1000 IU/mL was observed in 8 instances among 6 patients, 3 in each arm, with no associated hepatitis. Low-level DNA (<1000 IU/mL) was not indicative of reverse seroconversion, DNA increases, or ALT elevations.

conclusionsThe use of preemptive TAF therapy did not reduce the risk of HBsAg reverse seroconversion; however, the findings should be interpreted with caution as the study was underpowered due to slow enrolment leading to early termination. Low-level HBV DNA elevations were not associated with HBV reactivation. Thus, close HBsAg and ALT monitoring are adequate in HBsAg-negative patients undergoing rituximab-based chemotherapy.

Indexed as

Antiviral AgentsHepatitis BHepatitis B virusLymphoma, Non-HodgkinRituximabTenofovirVirus ActivationAdenineAgedAlanineAntineoplastic Combined Chemotherapy ProtocolsDNA, ViralDouble-Blind MethodFemaleHepatitis B AntibodiesHepatitis B Surface AntigensAdenineAlanineAntiviral AgentsDNA, ViralHepatitis B AntibodiesHepatitis B Surface AntigensRituximabTenofovirtenofovir alafenamideanti-HBc positivechemotherapyHBsAg negativeHBVhepatitis Blymphomareactivationrituximabtenofovir alafenamide

Identifiers

PMID41335575
PMCPMC12674154

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

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 Socratic graph.