Evidence map›Paper›PMID 26821154›Full record

Observational studyDigestive diseases and sciences2016

Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B: A 3-Year, Prospective, Real-World Study in France.

Patrick Marcellin, Fabien Zoulim, Christophe Hézode, Xavier Causse, Bruno Roche, Régine Truchi, Arnaud Pauwels, Denis Ouzan, Jérôme Dumortier, Georges-Philippe Pageaux and 10 more

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study 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 41 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 2 pooled it
9.1field-weighted citation impact, top 2% 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

41 citing papers in PubMed, 2 syntheses or guidelines pooled it, 72 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 15 institutions in 1 country.

Patrick MarcellinService d'Hépatologie, Hôpital Beaujon, 100 Bv du Gal Leclerc, Pavillion Abrami, 92110, Clichy, France. patrick.marcellin@bjn.aphp.fr.
Fabien ZoulimHôpital de la Croix Rousse, Lyon, France.
Christophe HézodeHôpital Henri Mondor, AP-HP, INSERM U955, Universite Paris-Est, Créteil, France.
Xavier CausseCentre Hospitalier Régional, Orléans, France.
Bruno RocheHôpital Paul Brousse, Villejuif, France.
Régine TruchiHôpital de l'Archet, Nice, France.
Arnaud PauwelsCentre Hospitalier, Gonesse, France.
Denis OuzanInstitut Arnault Tzanck, Saint Laurent Du Var, France.
Jérôme DumortierHôpital Edouard Hériot, Lyon, France.
Georges-Philippe PageauxHôpital Saint Eloi, Montpellier, France.
Marc BourlièreHôpital Saint Joseph, Marseille, France.
Ghassan RiachiHôpital Charles Nicolle, Rouen, France.
Jean-Pierre ZarskiHôpital de la Tronche, Grenoble, France.
Jean-François CadranelCentre Hospitalier Laennec, Creil, France.
Valérie TillietGilead Sciences, Boulogne-Billancourt, France.
Christiane SternGilead Sciences, Boulogne-Billancourt, France.
Pascal PétourGilead Sciences, Boulogne-Billancourt, France.
Olivier LibertGilead Sciences, Boulogne-Billancourt, France.
Silla M ConsoliHôpital Européen Georges Pompidou, Paris, France.
Dominique LarreyHôpital Saint Eloi, Montpellier, France.
Gilead Sciences (France) · FRHôpital Saint Eloi · FRCentre Hospitalier de Gonesse · FRCentre Hospitalier Laennec · FRCentre hospitalier régional d'Orléans · FRHôpital Beaujon · FRHôpital Charles-Nicolle · FRHôpital de la Croix-Rousse · FRHôpital Edouard Herriot · FRHôpital Européen · FRHôpital l'Archet · FRHôpital Paul-Brousse · FRHôpital Saint Joseph · FRInserm · FRInstitut Arnault Tzanck · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsTenofovir disoproxil fumarate (TDF) demonstrated potent and sustainable antiviral efficacy and a good safety profile in patients with chronic hepatitis B (CHB) in controlled clinical trials. Real-world data are important to confirm effectiveness and safety data in patient populations encountered in routine clinical practice.

methodsThis non-interventional, prospective, 36-month study included treatment-naïve and treatment-experienced patients with CHB initiating their first TDF regimen (monotherapy or combination therapy) in routine clinical practice in France. Clinical, virologic, biochemical, compliance, and safety data were collected.

resultsData from 440 consecutive patients from 58 centers were analyzed. The majority of the cohort was male (71 %), hepatitis B "e" antigen-negative (HBeAg-) (74 %), and treatment-experienced (56 %); 11 % were aged ≥65 years; and comorbidities were reported in 39 %. After 12 months, 92 % of the overall cohort achieved virologic response (HBV DNA <69 IU/mL) which was maintained to 36 months (96 %); virologic response was achieved by >90 % of patients irrespective of HBeAg status, age, or prior treatment history. At 36 months, 77 % of patients had normal alanine aminotransferase levels. Fourteen patients lost hepatis B surface (HBs) antigen, and seven seroconverted to anti-HBs. TDF was well tolerated over the 36-month study, including in 14 women who became pregnant during the study. Median estimated glomerular filtration rate did not change markedly from baseline irrespective of prior treatment history.

conclusionsTDF demonstrated potent virologic and biochemical responses across a broad range of patients reflective of routine clinical practice. The safety profile was consistent with results from pivotal trials.

Indexed as

Abdominal PainAdultAgedAntiviral AgentsAstheniaDiarrheaDNA, ViralFemaleFranceHeadacheHepatitis B, ChronicHepatitis B e AntigensHepatitis B Surface AntigensHumansHypophosphatemiaKidney DiseasesAntiviral AgentsDNA, ViralHepatitis B e AntigensHepatitis B Surface AntigensTenofovirHBVReal-worldRoutine practiceTenofovir

Identifiers

PMID26821154
PMCPMC5020114
OpenAlexW2261427425

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.