Evidence map›Paper›PMID 27418632›Full record

Observational studyGut2017

Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: results of the real-world, clinical practice HCV-TARGET study.

Tania M Welzel, David R Nelson, Giuseppe Morelli, Adrian Di Bisceglie, Rajender K Reddy, Alexander Kuo, Joseph K Lim, Jama Darling, Paul Pockros, Joseph S Galati and 8 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Gut, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01474811 (HCV-TARGET), which is not on this map. Cited by 41 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 3 pooled it
10.3field-weighted citation impact, top 1% 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.

NCT01474811 completednot on this map

HCV-TARGET: Hepatitis C Therapeutic Registry and Research Network - A Longitudinal, Observational Study.

TypeobservationalSponsorUniversity of North Carolina, Chapel HillRan2011 to 2022Enrolled13,559ConditionsHepatitis C
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 3 syntheses or guidelines pooled it, 90 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Efficacy and Safety of Direct-Acting Antivirals in Elderly Patients with Chronic Hepatitis C: A Nationwide Real-Life, Observational, Multicenter Study from Turkey.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2022
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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

18 authors at 9 institutions in 2 countries.

Tania M WelzelJW Goethe University Hospital, Frankfurt am Main, Germany.
David R NelsonUniversity of Florida, Gainesville, Florida, USA.
Giuseppe MorelliUniversity of Florida, Gainesville, Florida, USA.
Adrian Di BisceglieSaint Louis University School of Medicine, St. Louis, Missouri, USA.
Rajender K ReddyUniversity of Pennsylvania, Philadelphia, Pennsylvania, USA.
Alexander KuoUniversity of California, San Diego, San Diego, California, USA.
Joseph K LimYale University of School of Medicine, New Haven, Connecticut, USA.
Jama DarlingUniversity of North Carolina, Chapel Hill, North Carolina, USA.
Paul PockrosScripps Clinic, La Jolla, California, USA.
Joseph S GalatiResearch Specialists of Texas, Houston, Texas, USA.
Lynn M FrazierLiver Wellness Clinic, Little Rock, Arkansas, USA.
Saleh AlqahtaniJohns Hopkins University, Baltimore, Maryland, USA.
Mark S SulkowskiJohns Hopkins University, Baltimore, Maryland, USA.
Monika VainoriusUniversity of North Carolina, Chapel Hill, North Carolina, USA.
Lucy AkushevichUniversity of North Carolina, Chapel Hill, North Carolina, USA.
Michael W FriedUniversity of North Carolina, Chapel Hill, North Carolina, USA.
Stefan ZeuzemJW Goethe University Hospital, Frankfurt am Main, Germany.
HCV-TARGET Study Group
University of North Carolina at Chapel Hill · USGoethe University Frankfurt · DEJohns Hopkins University · USUniversity of Florida · USSaint Louis University · USScripps Clinic · USUniversity of California, San Diego · USUniversity of Pennsylvania · USYale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Using social networks to map and evaluate team science across CTSA hubsUL1TR001427 · NCATS · UNIVERSITY OF FLORIDA · PI MITCHELL, DUANE A. · 2015 to 2024
$37.2M
Yale Liver CenterP30DK034989 · NIDDK · YALE UNIVERSITY · PI YASUKO IWAKIRI · 1986 to 2026
$31.1M
University of Florida Older Americans Independence Center (OAIC)P30AG028740 · NIA · UNIVERSITY OF FLORIDA · PI CHRISTIAAN LEEUWENBURGH · 2007 to 2026
$22.8M
UF Clinical and Translational Science AwardUL1TR000064 · NCATS · UNIVERSITY OF FLORIDA · PI NELSON, DAVID R · 2012 to 2014
$12.2M
Mentoring Junior Faculty: Viral hepatitis Clinical ResearchK24DK066144 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI FRIED, MICHAEL W · 2004 to 2014
$1.5M
Mentorship in Liver DiseaseK24DK070528 · NIDDK · UNIVERSITY OF CINCINNATI · PI SHERMAN, KENNETH E · 2005 to 2014
$1.4M
Patient Oriented Research in Hepatitis C-infected Injection Drug UsersK24DA034621 · NIDA · JOHNS HOPKINS UNIVERSITY · PI SULKOWSKI, MARK SEBASTIAN · 2012 to 2022
$1.2M
NCATS NIH HHS UL1 TR000064NCATS NIH HHS UL1 TR001427NCATS NIH HHS UL1 TR001863NIA NIH HHS P30 AG028740NIDA NIH HHS K24 DA034621NIDDK NIH HHS K24 DK066144NIDDK NIH HHS K24 DK070528NIDDK NIH HHS P30 DK034989
6 · The paper itself

Abstract

objectiveDue to a high efficacy in clinical trials, sofosbuvir (SOF) and ribavirin (RBV) for 12 or 16 weeks is recommended for treatment of patients with HCV genotype (GT) 2 infection. We investigated safety and effectiveness of these regimens for GT2 in HCV-TARGET participants.

designHCV-TARGET, an international, prospective observational study evaluates clinical practice data on novel antiviral therapies at 44 academic and 17 community medical centres in North America and Europe. Clinical data were centrally abstracted from medical records. Selection of treatment regimen and duration was the investigator's choice. The primary efficacy outcome was sustained virological response 12 weeks after therapy (SVR12).

resultsBetween December 2013 and April 2015, 321 patients completed 12 weeks (n=283) or 16 weeks (n=38) of treatment with SOF and RBV. Prior treatment experience and cirrhosis was more frequent among patients in the 16-week regimen compared with 12 weeks (52.6% vs 27.6% and 63.2% vs 21.9%, respectively). Overall, SVR12 was 88.2%. The SVR12 in patients without cirrhosis was 91.0% and 92.9% for 12 or 16 weeks of therapy, respectively. In patients with cirrhosis treated for 12 or 16 weeks, SVR12 was 79.0% and 83%. In the multivariate analysis, liver cirrhosis, lower serum albumin and RBV dose at baseline were significantly associated with SVR12. Common adverse events (AEs) included fatigue, anaemia, nausea, headache, insomnia, rash and flu-like symptoms. Discontinuation due to AEs occurred in 2.8%.

conclusionsIn this clinical practice setting, SOF and RBV was safe and effective for treatment of patients with HCV GT2 infection. TRIAL REGISTRATION NUMBER: NCT01474811.

Indexed as

AdolescentAdultAgedAntiviral AgentsDrug Therapy, CombinationFemaleGenotypeHepacivirusHepatitis C, ChronicHumansLiver CirrhosisMaleMiddle AgedProspective StudiesRibavirinSerum AlbuminAntiviral AgentsRibavirinSerum AlbuminSofosbuvirCLINICAL TRIALSGENOTYPEHEPATITIS C

Identifiers

PMID27418632
PMCPMC5595101
OpenAlexW2473720327

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.