Evidence map›Paper›PMID 27605539›Full record

ArticleGut2016

Daclatasvir plus sofosbuvir, with or without ribavirin, achieved high sustained virological response rates in patients with HCV infection and advanced liver disease in a real-world cohort.

Tania M Welzel, Jörg Petersen, Kerstin Herzer, Peter Ferenci, Michael Gschwantler, Heiner Wedemeyer, Thomas Berg, Ulrich Spengler, Ola Weiland, Marc van der Valk and 5 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Gut, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02097966 (A Multicenter Compassionate Use Program of Daclatasvir), which is not on this map. Cited by 76 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
76citing papers in PubMed, 3 pooled it
23.9field-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.

NCT02097966 no longer availablenot on this map

A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C

Typeexpanded_accessSponsorBristol-Myers SquibbConditionsChronic Hepatitis CArmsDaclatasvir, Sofosbuvir, Ribavirin
3 · Its place in the literature

Who cites it

76 citing papers in PubMed, 3 syntheses or guidelines pooled it, 196 citations in OpenAlex.

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16 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 11 institutions in 5 countries.

Tania M WelzelUniversitätsklinikum der Johann Wolfgang Goethe Universität, Frankfurt am Main, Germany.
Jörg PetersenIFI Institut für Interdisziplinäre Medizin, Hamburg, Germany.
Kerstin HerzerUniversitätsklinikum Essen (AöR), Essen, Germany.
Peter FerenciDepartment of Internal Medicine III, Medizinische Universität Wien, Vienna, Austria.
Michael GschwantlerWilhelminenspital, Vienna, Austria.
Heiner WedemeyerMedizinische Hochschule Hannover, Hannover, Germany.
Thomas BergUniversitätsklinikum Leipzig, Leipzig, Germany.
Ulrich SpenglerUniversitätsklinikum Bonn, Bonn, Germany.
Ola WeilandKarolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden.
Marc van der ValkAcademic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Jürgen RockstrohUniversitätsklinikum Bonn, Bonn, Germany.
Markus Peck-RadosavljevicDepartment of Internal Medicine III, Medizinische Universität Wien, Vienna, Austria.
Yue ZhaoBristol-Myers Squibb, Princeton, New Jersey, USA.
Maria Jesus Jimenez-ExpositoBristol-Myers Squibb, Princeton, New Jersey, USA.
Stefan ZeuzemUniversitätsklinikum der Johann Wolfgang Goethe Universität, Frankfurt am Main, Germany.
Bristol-Myers Squibb (United States) · USGoethe University Frankfurt · DEMedical University of Vienna · ATUniversity Hospital Bonn · DEEssen University Hospital · DEInstitute for Interdisciplinary Medicine · DEKarolinska University Hospital · SEMedizinische Hochschule Hannover · DEUniversity Hospital Leipzig · DEUniversity of Amsterdam · NLWilhelminen Hospital · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWe assessed the effectiveness and safety of daclatasvir (DCV) plus sofosbuvir (SOF), with or without ribavirin (RBV), in a large real-world cohort, including patients with advanced liver disease.

designAdults with chronic HCV infection at high risk of decompensation or death within 12 months and with no available treatment options were treated in a European compassionate use programme. The recommended regimen was DCV 60 mg plus SOF 400 mg for 24 weeks; RBV addition or shorter duration was allowed at physicians' discretion. The primary endpoint was sustained virological response at post-treatment week 12 (SVR12).

resultsOf the 485 evaluable patients, 359 received DCV+SOF and 126 DCV+SOF+RBV. Most patients were men (66%), white (93%) and treatment-experienced (70%). The most frequent HCV genotypes were 1b (36%), 1a (33%) and 3 (21%), and 80% of patients had cirrhosis (42% Child-Pugh B/C; 46% Model for End-Stage Liver Disease score >10). SVR12 (modified intention-to-treat) was achieved by 91% of patients (419/460); 1 patient had virological breakthrough and 13 patients relapsed. Virological failure was not associated with treatment group (adjusted risk difference DCV+SOF minus DCV+SOF+RBV: 1.06%; 95% CI -2.22% to 4.35%). High SVR12 was observed regardless of HCV genotype or cirrhosis, liver transplant or HIV/HCV coinfection status. Twenty eight patients discontinued treatment due to adverse events (n=18) or death (n=10) and 18 died during follow-up. Deaths and most safety events were associated with advanced liver disease and not considered treatment related.

conclusionsDCV+SOF with or without RBV achieved high SVR12 and was well tolerated in a diverse cohort of patients with severe liver disease. TRIAL REGISTRATION NUMBER: NCT02097966.

Indexed as

HepacivirusHepatitis C, ChronicImidazolesLiver FailureRibavirinSofosbuvirAdultAgedAntiviral AgentsCarbamatesCohort StudiesCompassionate Use TrialsDrug MonitoringDrug Therapy, CombinationEuropeFemaleAntiviral AgentsCarbamatesdaclatasvirImidazolesPyrrolidinesRibavirinSofosbuvirValineANTIVIRAL THERAPYCHRONIC VIRAL HEPATITISCIRRHOSISHEPATITIS C

Identifiers

PMID27605539
PMCPMC5099229
OpenAlexW2507707536

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.