Evidence map›Paper›PMID 29377566›Full record

Trial reportLiver international : official journal of the International Association for the Study of the Liver2018

Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin.

Jordan J Feld, David E Bernstein, Ziad Younes, Hans Van Vlierberghe, Lois Larsen, Fernando Tatsch, Peter Ferenci

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Liver international : official journal of the International Association for the Study of the Liver, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 38% 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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin.Liver international : official journal of the International Association for the Study of the Liver · 2018
    Trial
  2. Article
  3. COVID-19 Drug Treatment in China.Current pharmacology reports · 2020
    Review
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

7 authors at 6 institutions in 4 countries.

Jordan J FeldToronto Centre for Liver Disease, Toronto General Hospital, Toronto, ON, Canada.ORCID 0000-0003-2640-2211
David E BernsteinNorth Shore University Hospital, Manhasset, NY, USA.
Ziad YounesGastroOne, Germantown, TN, USA.
Hans Van VlierbergheGhent University Hospital, Gent, Belgium.
Lois LarsenAbbVie Inc., North Chicago, IL, USA.
Fernando TatschAbbVie Inc., North Chicago, IL, USA.
Peter FerenciMedical University of Vienna, Vienna, Austria.
AbbVie (United States) · USAmerican College of Veterinary Surgeons · USGhent University Hospital · BEMedical University of Vienna · ATNorth Shore University Hospital · USToronto General Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND &

aimsSome individuals with hepatitis C virus infection treated with direct-acting antivirals require ribavirin to maximize sustained virological response rates. We describe the clinical management of ribavirin dosing in hepatitis C virus-infected patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin.

methodsWe performed a post hoc analysis of patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin for 12 or 24 weeks in six phase 3 trials. Multivariate stepwise logistic regression models assessed predictors associated with ribavirin dose adjustments and with developing anaemia.

resultsOf 1548 patients, 100 (6.5%) modified ribavirin dose due to haemoglobin declines, of which 99% achieved sustained virological response at 12 weeks post-treatment. Median time to first ribavirin dose reduction was 37 days. Low baseline haemoglobin was significantly associated with an increased risk of requiring ribavirin dose modification (odds ratio: 0.618 [0.518, 0.738]; P < .001) and developing anaemia (odds ratio: 0.379 [0.243, 0.593]; P < .001).

conclusionsRibavirin dose reductions were infrequent, occurred early in treatment, and did not impact sustained virological response at 12 weeks post-treatment. Patients with low baseline haemoglobin should be monitored for on-treatment anaemia.

Indexed as

2-NaphthylamineAdultAnilidesAntiviral AgentsCarbamatesCyclopropanesDrug Therapy, CombinationFemaleHepacivirusHepatitis CHumansInternationalityLactams, MacrocyclicLogistic ModelsMacrocyclic CompoundsMale2-NaphthylamineAnilidesAntiviral AgentsCarbamatesCyclopropanesdasabuvirLactams, MacrocyclicMacrocyclic CompoundsombitasvirparitaprevirProlineRibavirinRitonavirSulfonamidesUracilValineanaemiadasabuvirombitasvirparitaprevirribavirin

Identifiers

PMID29377566
PMCPMC6175401
OpenAlexW2794036127

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.