Evidence map›Paper›PMID 19960257›Full record

Trial reportDigestive diseases and sciences2010

A randomized controlled trial of double versus triple therapy with amantadine for genotype 1 chronic hepatitis C in Latino patients.

Jorge Méndez-Navarro, Ruby A Chirino, Kathleen E Corey, Emmanuel C Gorospe, Hui Zheng, Segundo Morán, Jesus A Juarez, Raymond T Chung, Margarita Dehesa-Violante

Erratum issuedAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Digestive diseases and sciences, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.6field-weighted citation impact, top 30% 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

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 6 citations in OpenAlex.

  1. Aminoadamantanes for chronic hepatitis C.The Cochrane database of systematic reviews · 2014
    Pooled it
  2. Pooled it
  3. Review
  4. Article
4 · The record

Corrections and comments

  • Erratum issued
    Juarez, Jesus A [added]
5 · Who and what money

Authors and funding

9 authors at 5 institutions in 2 countries.

Jorge Méndez-NavarroDepartamento de Gastroenterología, Hospital de Especialidades, Centro Médico Nacional Siglo XXI, IMSS, Av. Cuauhtemoc 330, Col. Doctores, 06725, Mexico, DF, Mexico. jmndoc@yahoo.com
Ruby A Chirino
Kathleen E Corey
Emmanuel C Gorospe
Hui Zheng
Segundo Morán
Jesus A Juarez
Raymond T Chung
Margarita Dehesa-Violante
Centro Medico Nacional Siglo XXI · MXHarvard University · USHospital de Especialidades · MXJohns Hopkins Medicine · USMassachusetts General Hospital · US

Funding

Patient-Oriented Research on Hepatitis in Special PopulationsK24DK078772 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI CHUNG, RAYMOND T · 2007 to 2016
$1.6M
NIDDK NIH HHS K24 DK078772
6 · The paper itself

Abstract

backgroundWith only a third of Latinos achieving sustained virologic response (SVR), there is a need for enhanced HCV treatment. Amantadine has been proposed to improve response rates in addition to standard therapy with peginterferon alpha and ribavirin. Our objective is to evaluate whether triple therapy with amantadine improves SVR rates in this special population.

methodTreatment-naïve Latino subjects with HCV genotype 1 infection were randomized to receive peginterferon alpha-2a plus weight-based ribavirin for 48 weeks (double therapy) or the same regimen plus amantadine 200 mg daily (triple therapy). The primary endpoint was SVR. Predictors of liver fibrosis using APRI and Forns indices were also evaluated.

resultsWe enrolled 124 patients with chronic hepatitis C genotype 1. Sixty-three received conventional therapy and 61 patients had triple therapy with amantadine. SVR at week 72 was achieved in 25 patients (39.7%) vs. 26 patients (42.6%) in the double and triple regimen, respectively (p=0.561). After multivariate analysis, advanced fibrosis, obesity, and low pretreatment ALT levels were associated with non-response in both groups (p=0.0234, p=0.0012, p=0.0249, respectively). APRI values delimited an area under the ROC curve (AUROC) of 0.724 and Forns index with AUROC of 0.733. There was no difference between both indices in predicting significant fibrosis (Knodell index: F3-F4).

conclusionOur study demonstrates that the addition of amantadine to standard treatment of chronic HCV does not improve SVR rates in Latino patients with genotype 1. Further research to improve response rates in this special population is needed.

Indexed as

AdultAmantadineAntiviral AgentsBiopsyChi-Square DistributionDrug Therapy, CombinationFemaleGenotypeHepacivirusHepatitis C AntibodiesHepatitis C, ChronicHumansInterferon-alphaInterferon alpha-2LiverLiver CirrhosisAmantadineAntiviral AgentsHepatitis C AntibodiesInterferon-alphaInterferon alpha-2peginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsRibavirinRNA, Viral

Identifiers

PMID19960257
PMCPMC3747563
OpenAlexW2149946579

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.