Evidence map›Paper›PMID 39327857›Full record

Trial reportAlimentary pharmacology & therapeutics2024

Eight-year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials.

Maria Buti, Young-Suk Lim, Henry Lik Yuen Chan, Kosh Agarwal, Patrick Marcellin, Maurizia R Brunetto, Wan-Long Chuang, Harry L A Janssen, Scott K Fung, Namiki Izumi and 13 more

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 3 pooled it
–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.

NCT01940341 phase3completednot on this map

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Negative, Chronic Hepatitis B

TypeinterventionalSponsorGilead SciencesRan2013 to 2022Enrolled426ConditionsHBeAg-negative Chronic Hepatitis BArmsTAF, TDF, TAF Placebo, TDF Placebo
NCT01940471 phase3completednot on this map

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Positive, Chronic Hepatitis B

TypeinterventionalSponsorGilead SciencesRan2013 to 2022Enrolled875ConditionsHBeAg-positive Chronic Hepatitis BArmsTAF, TDF, TAF Placebo, TDF Placebo
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. [APASL clinical practice guidelines on the management of chronic hepatitis B infection: a 2026 update].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2026
    Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Novel insights into chronic HBV infection.Nature reviews. Gastroenterology & hepatology · 2026
    Article
  16. Article
  17. Review
  18. Review
  19. Article
  20. 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

23 authors.

Maria ButiHospital Universitario Vall d'Hebron, Barcelona, Spain.ORCID 0000-0002-0732-3078
Young-Suk LimAsan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.ORCID 0000-0002-1544-577X
Henry Lik Yuen ChanFaculty of Medicine, The Chinese University of Hong Kong, HMA Office, Tai Wai, Shatin, Hong Kong.
Kosh AgarwalInstitute of Liver Studies, King's College Hospital NHS Foundation Trust, London, UK.
Patrick MarcellinHepatology Department, Hôpital Beaujon, APHP, INSERM, University of Paris, Clichy, France.
Maurizia R BrunettoDepartment of Clinical and Experimental Medicine, University of Pisa and Hepatology Unit, Pisa University Hospital, Pisa, Italy.
Wan-Long ChuangKaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung City, Taiwan.
Harry L A JanssenErasmus Medical Center, Rotterdam, Netherlands and Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
Scott K FungDepartment of Medicine, University of Toronto, Toronto, Ontario, Canada.
Namiki IzumiDepartment of Gastroenterology and Hepatology, Japanese Red Cross Musashino Hospital, Tokyo, Japan.
Maciej S JablkowskiMedical University of Łódź, Łódź, Poland.
Dzhamal AbdurakhmanovSechenov University, Moscow, Russia.
Frida AbramovGilead Sciences, Inc., Foster City, California, USA.
Hongyuan WangGilead Sciences, Inc., Foster City, California, USA.
Irina BotrosGilead Sciences, Inc., Foster City, California, USA.
Leland J YeeGilead Sciences, Inc., Foster City, California, USA.ORCID 0000-0002-0369-5878
Roberto MateoGilead Sciences, Inc., Foster City, California, USA.
John F FlahertyGilead Sciences, Inc., Foster City, California, USA.
Anu OsinusiGilead Sciences, Inc., Foster City, California, USA.
Calvin Q PanNYU Langone Health, New York University Grossman School of Medicine, New York, New York, USA.
X ShalimarAll India Institute of Medical Sciences, New Delhi, India.
Wai-Kay SetoDepartment of Medicine and School of Clinical Medicine, The University of Hong Kong, Hong Kong.ORCID 0000-0002-9012-313X
Edward J GaneUniversity of Auckland, Auckland, New Zealand.

Funding

Gilead Sciences
6 · The paper itself

Abstract

backgroundIn two phase 3 studies, tenofovir alafenamide (TAF) showed non-inferior efficacy versus tenofovir disoproxil fumarate (TDF), with more favourable renal and bone safety in patients with chronic hepatitis B (CHB).

aimsHere, we report the studies' final 8-year results.

methodsCHB patients (hepatitis B e antigen [HBeAg]-negative and HBeAg-positive) were randomised (2:1) to double-blind TAF 25 mg/day or TDF 300 mg/day for up to 3 years, followed by open-label (OL) TAF through year 8. Virological, biochemical, serological and fibrosis responses, and safety, including bone and renal parameters, were evaluated. Resistance to TAF was assessed annually by deep sequencing of polymerase/reverse transcriptase and by phenotyping.

resultsAmong 1298 patients randomised to double-blind TAF (n = 866) or double-blind TDF (n = 432), 775 in the TAF group and 382 in the TDF group received OL TAF, including 180 and 202 who switched from TDF to TAF at year 2 (TDF2y → TAF6y) or year 3 (TDF3y → TAF5y), respectively. At year 8, among patients in the TAF8y, TDF2y → TAF6y and TDF3y → TAF5y groups, 69%, 66% and 73% (missing-equals-failure analysis) and 95%, 94% and 97% (missing-equals-excluded) of patients, respectively, achieved HBV DNA <29 IU/mL. Estimated glomerular filtration rate (Cockcroft-Gault method; eGFR

conclusionLong-term TAF treatment exhibited favourable safety and tolerability with high rates of viral suppression and no development of resistance. CLINICALTRIALS: gov numbers NCT01940341 and NCT01940471.

Indexed as

AdenineAlanineAntiviral AgentsHepatitis B, ChronicTenofovirAdultDouble-Blind MethodDrug Resistance, ViralFemaleHepatitis B e AntigensHepatitis B virusHumansMaleMiddle AgedTreatment OutcomeAdenineAlanineAntiviral AgentsHepatitis B e AntigensTenofovirtenofovir alafenamide

Identifiers

PMID39327857
PMCPMC11599788

What OpenQuestion holds

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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 OpenQuestion graph.