Evidence map›Paper›PMID 21876446›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2011

Randomized trial comparing dose reduction and growth factor supplementation for management of hematological side effects in HIV/hepatitis C virus patients receiving pegylated-interferon and ribavirin.

Andrew H Talal, Ruei-Chi Liu, Marija Zeremski, Rositsa Dimova, Lorna Dove, Daniel Pearce, Tarek Hassanein, Leleka Doonquah, David Aboulafia, Jorge Rodriguez and 6 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2011. 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
1.0field-weighted citation impact, top 23% 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, 10 citations in OpenAlex.

  1. [Not Available].The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2014
    Article
  2. Article
  3. CIHR Canadian HIV Trials Network Coinfection and Concurrent Diseases Core: Canadian guidelines for management and treatment of HIV/hepatitis C coinfection in adults.The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2013
    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

16 authors at 7 institutions in 1 country.

Andrew H TalalCenter for the Study of Hepatitis C, Division of Gastroenterology and Hepatology, Department of Medicine, Weill Cornell Medical College, New York, NY 10065, USA. aht2002@med.cornell.edu
Ruei-Chi Liu
Marija Zeremski
Rositsa Dimova
Lorna Dove
Daniel Pearce
Tarek Hassanein
Leleka Doonquah
David Aboulafia
Jorge Rodriguez
Hector Bonilla
Jeffrey Galpin
Judy A Aberg
Barbara Johnston
Marshall J Glesby
Ira M Jacobson
Cornell University · USCancer Research And Biostatistics · USColumbia University · USNew York University · USSaint Vincent's Catholic Medical Center · USVirginia Mason Medical Center · USWestern University of Health Sciences · US

Funding

Complications of Chronic Viral InfectionsK24AI078884 · NIAID · WEILL MEDICAL COLL OF CORNELL UNIV · PI GLESBY, MARSHALL J · 2008 to 2012
$892k
VIRAL AND IMMUNE RESPONSE TO THERAPY FOR HIV IN THE GALTK08DK002573 · NIDDK · WEILL MEDICAL COLLEGE OF CORNELL UNIV · PI TALAL, ANDREW H · 1998 to 2003
$387k
NIAID NIH HHS K24 AI078884NIDDK NIH HHS K08 DK002573
6 · The paper itself

Abstract

backgroundPegylated-interferon (PEG-IFN) and ribavirin (RBV), current standard treatment for hepatitis C virus (HCV) infection, are frequently associated with neutropenia and anemia, leading to high treatment discontinuation rates in HIV/HCV-coinfected patients. Our objective was to compare the effectiveness of intervening with hematologic growth factors versus dose reductions of standard HCV therapy for the management of treatment-induced hematologic disorders.

methodsNinety-two HIV/HCV-coinfected, therapy-naive subjects received PEG-IFN alfa-2b 1.5 μg·kg⁻¹·wk⁻¹ and RBV 13 ± 2 mg·kg⁻¹·d⁻¹ for up to 48 weeks. Before treatment initiation, subjects were randomized to subsequently receive growth factors, recombinant human erythropoietin (rHuEPO) and/or granulocyte colony-stimulating factor, or dose reduction (RBV and/or PEG-IFN) for anemia and neutropenia management, respectively. We analyzed the ability of each management strategy to control anemia and neutropenia and the percentage of subjects who achieved a successful treatment outcome according to the different management strategies.

resultsDuring treatment, 43 subjects developed anemia (human erythropoietin, n = 24; dose reduction, n = 19), whereas 25 subjects developed neutropenia (granulocyte colony-stimulating factor, n = 10; dose reduction, n = 15). After the intervention, the increase in both hemoglobin and absolute neutrophil counts did not differ between the 2 side effect management strategies. Sustained response percentages were similar comparing anemic and neutropenic subjects regardless of management strategy (anemia: recombinant human erythropoietin, 29% versus dose reduction, 21%, P = 0.92; neutropenia: granulocyte colony-stimulating factor, 40% versus dose reduction, 20%, P = 0.46).

conclusionsGrowth factor supplementation and dose reduction do not seem to differ as management strategies for anemia and neutropenia in HIV/HCV-coinfected individuals treated with PEG-IFN/RBV.

Indexed as

AdultAgedAnemiaAntiviral AgentsErythropoietinFemaleGranulocyte Colony-Stimulating FactorHepatitis C, ChronicHIV InfectionsHumansIntercellular Signaling Peptides and ProteinsInterferon-alphaInterferon alpha-2MaleMiddle AgedMulticenter Studies as TopicAntiviral AgentsErythropoietinGranulocyte Colony-Stimulating FactorIntercellular Signaling Peptides and ProteinsInterferon-alphaInterferon alpha-2peginterferon alfa-2bPolyethylene GlycolsRecombinant ProteinsRibavirin

Identifiers

PMID21876446
PMCPMC3386143
OpenAlexW2047318662

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.