Evidence map›Paper›PMID 34059991›Full record

Observational studyDigestive diseases and sciences2022

Safety and Effectiveness of Tenofovir Alafenamide in Usual Clinical Practice Confirms Results of Clinical Trials: TARGET-HBV.

David E Bernstein, Huy N Trinh, Eugene R Schiff, Coleman I Smith, Andrea R Mospan, Richard C Zink, Michael W Fried, Anna S Lok

Registry-linked trialAbstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Digestive diseases and sciences, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03692897 (An Observational Study of Patients With Chronic Hepatitis B), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 26% 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.

NCT03692897 terminatednot on this map

An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection

TypeobservationalSponsorTarget PharmaSolutions, Inc.Ran2018 to 2025Enrolled1,708ConditionsHepatitis B, Hepatitis, Liver DiseasesArmsAll approved therapies for the treatment of Chronic Hepatitis B (CHB)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Review
  3. 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

8 authors at 5 institutions in 1 country.

David E BernsteinSandra Atlas Bass Center for Liver Diseases, Zucker School of Medicine at Hofstra/Northwell, 400 Community Drive, Manhasset, NY, 11030, USA.
Huy N TrinhSan Jose Gastroenterology, 2331 Montpelier Dr., Suite B, San Jose, CA, 95116, USA.
Eugene R SchiffUniversity of Miami School of Medicine, 1500 N.W. 12 Ave., E-1101, Miami, FL, 33136, USA.
Coleman I SmithGeorgetown University Hospital, 3800 Reservoir Rd NW, 2PHC, Washington, DC, 20007, USA.
Andrea R MospanTarget RWE, 2520 Meridian Pkwy, Suite 105, Durham, NC, 27713, USA.
Richard C ZinkTarget RWE, 2520 Meridian Pkwy, Suite 105, Durham, NC, 27713, USA.
Michael W FriedTarget RWE, 2520 Meridian Pkwy, Suite 105, Durham, NC, 27713, USA.
Anna S LokDivision of Gastroenterology and Hepatology, University of Michigan, 1500 East Medical Center Drive, 3912 Taubman Center, SPC 5362, Ann Arbor, MI, 48109, USA. aslok@med.umich.edu.
Target (United States) · USA. Alfred Taubman Health Care Center · USGeorgetown University · USHofstra University · USUniversity of Miami · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNucleos(t)ide analogues, with a proven record of safety and efficacy, have been the therapy of choice for over a decade for the treatment of chronic hepatitis B. The approval of tenofovir alafenamide (TAF) in 2016 provided an additional treatment option.

aimsThe aim of this study was to evaluate the characteristics and clinical outcomes of patients treated with TAF in usual clinical practice.

methodsRetrospective data from electronic health records was obtained from those enrolled in TARGET-HBV, a longitudinal observational cohort study of patients with chronic hepatitis B managed according to local practice standards at community and academic medical centers throughout the U.S.

resultsOf 500 patients enrolled, most were male (66%) and of Asian race (66%) with median age of 55 years. Cirrhosis was evident in 15%. Most patients (82%) had switched to TAF after treatment with other antivirals. The perceived safety profile of TAF was cited as the primary reason for changing therapy (32%). TAF was well tolerated and only 4 patients discontinued therapy due to adverse event during a median duration of TAF dosing of 74 weeks. Among those with paired laboratory data 12-18 months after switching to TAF, biochemical response and HBV DNA suppression was maintained. Most patients had normal renal function which was essentially unchanged throughout follow-up.

conclusionsTAF is frequently utilized in routine clinical practice due to the perception of its improved safety profile. The current study supports the growing body of evidence regarding the safety and effectiveness of TAF. Trial Registration ClinicalTrials.gov identifier: NCT03692897, https://clinicaltrials.gov/ct2/show/NCT03692897 .

Indexed as

Hepatitis B, ChronicAdenineAlanineAntiviral AgentsFemaleHepatitis B virusHumansMaleMiddle AgedRetrospective StudiesTenofovirTreatment OutcomeAdenineAlanineAntiviral AgentsTenofovirtenofovir alafenamideAntiviral therapyHBV DNAHepatitis BTenofovir disoproxil fumarate (TDF)

Identifiers

PMID34059991
OpenAlexW3165770763

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.