Evidence map›Paper›PMID 26576555›Full record

ArticleDigestive diseases and sciences2016

Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B: A 3-Year Prospective Field Practice Study in Germany.

Jörg Petersen, Renate Heyne, Stefan Mauss, Jörg Schlaak, Willibald Schiffelholz, Christoph Eisenbach, Heinz Hartmann, Manfred Wiese, Klaus Boeker, Hanns-Friedrich Loehr and 9 more

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In one paragraph

Article in Digestive diseases and sciences, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
4.8field-weighted citation impact, top 4% 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

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 54 citations in OpenAlex.

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  12. Repositioned Drugs for COVID-19-the Impact on Multiple Organs.SN comprehensive clinical medicine · 2021
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 9 institutions in 1 country.

Jörg PetersenIFI Institut für Interdisziplinäre Medizin an der Asklepios Klinik St. Georg Haus L, University of Hamburg, Lohmühlenstr 5, 20099, Hamburg, Germany. petersen@ifi-medizin.de.
Renate HeyneLeberzentrum Checkpoint, Berlin, Germany.
Stefan MaussZentrum für HIV und Hepatogastroenterologie, Düsseldorf, Germany.
Jörg SchlaakUniversitätsklinikum, Essen, Germany.
Willibald SchiffelholzGastroenterologische Schwerpunktpraxis, Augsburg, Germany.
Christoph EisenbachUniversitätsklinikum, Heidelberg, Germany.
Heinz HartmannGastroenterologische Gemeinschaftspraxis, Herne, Germany.
Manfred WieseGastroenterologische Gemeinschaftspraxis, Leipzig, Germany.
Klaus BoekerLeberpraxis, Hannover, Germany.
Hanns-Friedrich LoehrFacharztpraxis für Innere Medizin, Wiesbaden, Germany.
Christine JohnFacharztpraxis für Innere Medizin, Berlin, Germany.
Maria LeuschnerHepatologische Schwerpunktpraxis, Offenbach, Germany.
Christian TrautweinUniversitätsklinikum, Aachen, Germany.
Gisela FeltenGastroenterologische Gemeinschaftspraxis, Herne, Germany.
Andreas TreinGemeinschaftspraxis, Stuttgart, Germany.
Wolfgang KrausePraxis Dr. Krause, Bayreuth, Germany.
Susanne RuppertGilead Sciences, Martinsried, Germany.
Tobias WargerGilead Sciences, Martinsried, Germany.
Dietrich HueppeGastroenterologische Gemeinschaftspraxis, Herne, Germany.
Praxis für Humangenetik · DEGilead Sciences (Germany) · DEAsklepios Klinik St. Georg · DECenter for HIV and Hepatogastroenterology · DEEssen University Hospital · DEOrthopädische Praxis · DEPraxis für Hämatologie und Onkologie · DEUniversitätsklinikum Aachen · DEUniversity Hospital Heidelberg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsMultiple clinical trials have demonstrated the efficacy and safety of tenofovir disoproxil fumarate (TDF) in chronic hepatitis B (CHB). However, long-term efficacy and safety data for TDF in real-life clinical practice are limited.

methodsProspective German field practice study in CHB-mono-infected patients. Patients were TDF-naïve but could have been treated previously with other HBV antivirals.

resultsEfficacy analysis included 400 patients; 301 (75 %) completed 36 months of TDF treatment. Both treatment-naïve and treatment-experienced patients showed a rapid decline in HBV DNA within 3 months of TDF initiation. After 36 months, HBV DNA < 69 IU/mL was achieved by 91 % of treatment-naïve patients (90 and 92 % in hepatitis B "e" antigen [HBeAg]-positive and [HBeAg]-negative, respectively) and 96 % of treatment-experienced patients (93 and 97 %, respectively). Three patients experienced virologic breakthrough, all with reported non-compliance. Overall, 5.7 % HBeAg-positive and 2.2 % HBeAg-negative patients lost hepatitis B surface antigen. Safety data were consistent with the known TDF safety profile; the most commonly reported adverse events possibly related to TDF were fatigue (2.0 %) and headache (2.0 %). Few patients (1.3 %) experienced renal-related adverse reactions. Creatinine clearance remained relatively stable over time; patients responded favorably where TDF was dose adjusted per label for decreased creatinine clearance.

conclusionsTDF showed a favorable tolerability profile and induced rapid and sustained suppression of HBV DNA in patients with CHB treated for up to 3 years in routine clinical practice, irrespective of treatment history. Efficacy and safety in this heterogeneous patient population were consistent with data from clinical trials.

Indexed as

AdultAntiviral AgentsCreatinineDNA, ViralElasticity Imaging TechniquesFatigueFemaleGermanyHeadacheHepatitis B, ChronicHepatitis B e AntigensHepatitis B Surface AntigensHumansKidney DiseasesLiverLiver CirrhosisAntiviral AgentsCreatinineDNA, ViralHepatitis B e AntigensHepatitis B Surface AntigensTenofovirChronic hepatitis BClinical practiceReal worldTenofovir disoproxil fumarate

Identifiers

PMID26576555
OpenAlexW2240377523

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.