Evidence map›Paper›PMID 26510638›Full record

Observational studyAlimentary pharmacology & therapeutics2016

Entecavir safety and effectiveness in a national cohort of treatment-naïve chronic hepatitis B patients in the US - the ENUMERATE study.

J Ahn, H M Lee, J K Lim, C Q Pan, M H Nguyen, W Ray Kim, A Mannalithara, H Trinh, D Chu, T Tran and 5 more

Abstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Alimentary pharmacology & therapeutics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
5.9field-weighted citation impact, top 3% 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

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 70 citations in OpenAlex.

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  18. A case of entecavir-associated bullous fixed drug eruption and a review of literature.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2019
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 12 institutions in 1 country.

J AhnDivision of Gastroenterology & Hepatology, Oregon Health & Science University, Portland, OR, USA.
H M LeeGastroenterology/Hepatology Division, Tufts Medical Center, Boston, MA, USA.
J K LimDigestive Diseases, Yale University, New Haven, CT, USA.
C Q PanDepartment of Medicine, NYU Langone, New York, NY, USA.
M H NguyenDivision of Gastroenterology & Hepatology, Stanford University, Stanford, CA, USA.
W Ray KimDivision of Gastroenterology & Hepatology, Stanford University, Stanford, CA, USA.
A MannalitharaDivision of Gastroenterology & Hepatology, Stanford University, Stanford, CA, USA.
H TrinhSan Jose Gastroenterology, San Jose, CA, USA.
D ChuAlbert Einstein College of Medicine, New York, NY, USA.
T TranDepartment of Medicine, Cedars Sinai Medical Center, Los Angeles, CA, USA.
A MinDivision of Gastroenterology, Mount Sinai Beth Israel, New York, NY, USA.
S DoDigestive Health Associates of Texas, Plano, TX, USA.
H TeDigestive Disease Center, University of Chicago, Chicago, IL, USA.
K R ReddyDivision of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA, USA.
A S LokDivision of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, USA.
Stanford University · USAlbert Einstein College of Medicine · USCedars-Sinai Medical Center · USDigestive Health Associates of Texas · USMount Sinai Beth Israel · USNYU Langone Health · USOregon Health & Science University · USTufts Medical Center · USUniversity of Chicago · USUniversity of Michigan–Ann Arbor · USUniversity of Pennsylvania · USYale University · US

Funding

Hepatitis B Clinical Research Network Clinical Center: Michigan - Hawaii ConsortiumU01DK082863 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI LOK, ANNA S.F. · 2008 to 2020
$3.7M
Patient-oriented and effectiveness research in chronic liver diseaseK24DK092336 · NIDDK · STANFORD UNIVERSITY · PI KIM, W. RAY · 2012 to 2016
$627k
NIDDK NIH HHS K24 DK092336NIDDK NIH HHS U01 DK082863
6 · The paper itself

Abstract

backgroundEntecavir (ETV) has been shown to be safe and efficacious in randomised controlled trials in highly selected patients with hepatitis B virus (HBV) infection.

aimTo determine the safety and effectiveness of ETV in 'real-world' HBV patients in the United States (US).

methodsTreatment-naïve HBV patients ≥18 years old who received ETV for ≥12 months between 2005 and 2013 were included in a retrospective, cohort study. Rates of ALT normalisation, undetectable HBV DNA, HBeAg and HBsAg loss/seroconversion, adverse events (AE) and clinical outcomes were evaluated.

resultsOf 841 patients, 658 [65% male, 83% Asian; median age 47 years] met the inclusion criteria. 36% were HBeAg+ and 9.3% cirrhotic. 89% had abnormal ALT. Baseline median HBV DNA was 5.8 log 10 IU/mL. Median duration of ETV treatment was 4 years. Rates of ALT normalisation at 1, 3 and 5 years were 37.2%, 48.7% and 56.2% in HBeAg+ and 39.6%, 46.8% and 55.6% in HBeAg- patients. HBV DNA was undetectable at 1, 3 and 5 years in 34.6%, 64.7% and 84.6% in HBeAg+ patients, and 81.9%, 90.3% and 96.2% in HBeAg patients. Five-year cumulative probability of HBeAg loss and seroconversion was 46% and 33.7% and HBsAg loss was 4.6%. ETV was discontinued due to adverse events in 1.2% of patients. Hepatic decompensation occurred in 0.8%, liver cancer in 2.7% and death in 0.6%.

conclusionEntecavir treatment was safe in a large cohort of US patients, but ALT normalisation and hepatitis B virus DNA suppression rates were lower than previously reported in clinical trials.

Indexed as

AdolescentAdultAgedAged, 80 and overAntiviral AgentsFemaleGuanineHepatitis B, ChronicHepatitis B e AntigensHepatitis B Surface AntigensHepatitis B virusHumansMaleMiddle AgedRetrospective StudiesYoung AdultAntiviral AgentsentecavirGuanineHepatitis B e AntigensHepatitis B Surface Antigens

Identifiers

PMID26510638
PMCPMC4926997
OpenAlexW1934610604

What OpenQuestion holds

Textmetadata
LicenceTDM
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.