Evidence map›Paper›PMID 20974502›Full record

Trial reportJournal of hepatology2011

Insulin resistance predicts re-treatment failure in an efficacy study of peginterferon-α-2a and ribavirin in HIV/HCV co-infected patients.

Marie-Louise C Vachon, Stephanie H Factor, Andrea D Branch, Maria-Isabel Fiel, Maribel Rodriguez-Torres, Norbert Bräu, Richard K Sterling, Jihad Slim, Andrew H Talal, Douglas T Dieterich and 1 more

Abstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of hepatology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. [Not Available].The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2014
    Article
  4. Article
  5. 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

11 authors.

Marie-Louise C VachonDivision of Liver Diseases, Mount Sinai School of Medicine, NY, USA. marie-louise.vachon@mountsinai.org
Stephanie H Factor
Andrea D Branch
Maria-Isabel Fiel
Maribel Rodriguez-Torres
Norbert Bräu
Richard K Sterling
Jihad Slim
Andrew H Talal
Douglas T Dieterich
Mark S Sulkowski

Funding

ZINC AND CA EDTA THERAPY OF PLUMBISMM01RR000052 · NCRR · JOHNS HOPKINS UNIVERSITY · PI FLEXNER, CHARLES W. · 1985 to 2007
$37.3M
The Impact of HCV Treatment in HIV/HCV coinfected and HCV monoinfected Incarcerated Persons on HCV EliminationR01DA013806 · NIDA · JOHNS HOPKINS UNIVERSITY · PI IRVIN, RISHA, THOMAS, DAVID L · 2000 to 2024
$8.7M
Management/Hepatitis C/HIV-infected and Uninfected IDU'sR01DA016065 · NIDA · JOHNS HOPKINS UNIVERSITY · PI SULKOWSKI, MARK SEBASTIAN · 2003 to 2018
$8.0M
HIV HCV Coinfection Antiviral Therapy and FibrosisR37DA013806 · NIDA · JOHNS HOPKINS UNIVERSITY · PI THOMAS, DAVID L · 2010 to 2019
$7.0M
Optimizing Vitamin D Treatment in HIV/AIDS: An RCTR01DA031095 · NIDA · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI BRANCH, ANDREA D., DIETERICH, DOUGLAS THOMAS · 2010 to 2014
$3.3M
Modulation of HCV Gene ExpressionR01DK066939 · NIDDK · MOUNT SINAI SCHOOL OF MEDICINE OF NYU · PI BRANCH, ANDREA D. · 2004 to 2010
$2.0M
Clinical Outcomes and the HCV Core GeneR01DK090317 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI BRANCH, ANDREA D. · 2010 to 2014
$2.0M
HCV Alternate Reading Frame Protein in HIV/HCV Co-infectR01DA016156 · NIDA · MOUNT SINAI SCHOOL OF MEDICINE OF NYU · PI BRANCH, ANDREA D. · 2003 to 2007
$1.9M
Patient Oriented Research in Hepatitis C-infected Injection Drug UsersK24DA034621 · NIDA · JOHNS HOPKINS UNIVERSITY · PI SULKOWSKI, MARK SEBASTIAN · 2012 to 2022
$1.2M
CIHRNCRR NIH HHS M01 RR000052NIDA NIH HHS DA016156NIDA NIH HHS DA13806NIDA NIH HHS DA16065NIDA NIH HHS K24 DA034621NIDA NIH HHS R01 DA013806NIDA NIH HHS R01 DA016065NIDA NIH HHS R01 DA016156NIDA NIH HHS R01 DA031095NIDA NIH HHS R37 DA013806NIDDK NIH HHS DK066939NIDDK NIH HHS R01 DK066939NIDDK NIH HHS R01 DK090317
6 · The paper itself

Abstract

BACKGROUND &

aimsFew studies evaluated the efficacy of HCV re-treatment and the predictors of response in HIV/HCV co-infected patients. The role of insulin resistance as a predictor of response in this population is unknown. The aim of this study is to evaluate the safety and efficacy of pegylated interferon-α-2a and ribavirin in re-treatment of HIV/HCV co-infected patients, predictors of sustained virological response, including insulin resistance, and the relationship between insulin resistance and liver histology.

methodsThis prospective, multi-centered study included HIV/HCV co-infected patients with prior interferon-based treatment failure. Patients received pegylated interferon-α-2a and ribavirin for 48 weeks. Serum HCV RNA was measured 24 weeks post treatment to assess sustained virological response. Insulin resistance was defined as HOMA-IR >2. Correlations between baseline insulin resistance and steatosis, and/or cirrhosis were determined.

resultsSustained virological response was achieved in 14/96 (15%) patients. 35% of patients with HOMA-IR < 2 (6/17) achieved sustained virological response vs 14% (5/36) of those with HOMA-IR between 2-4, and 7% (3/41) of those with HOMA-IR > 4 (p = 0.01). In multivariable analysis, insulin resistance and log₁₀ HCV RNA were negatively associated with sustained virological response [AOR 0.17; 95% CI 0.05-0.64, p = 0.009, and AOR 0.36; 95% CI 0.14-0.93, p = 0.04, respectively]. Steatosis and cirrhosis correlated with insulin resistance (p = 0.02 and 0.03, respectively) but neither independently predicted sustained virological response. Discontinuations due to severe adverse events occurred in 8% of cases, and 2 patients died of unrelated causes.

conclusionsIn HIV/HCV co-infected patients undergoing re-treatment, sustained virological response rate is low; those patients without insulin resistance are significantly more likely to achieve sustained virological response.

Indexed as

AdultAntiviral AgentsCase-Control StudiesFemaleHepatitis C, ChronicHIV InfectionsHumansInsulin ResistanceInterferon-alphaInterferon alpha-2LiverMaleMiddle AgedPolyethylene GlycolsProspective StudiesRecombinant ProteinsAntiviral AgentsInterferon-alphaInterferon alpha-2peginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsRibavirinRNA, Viral

Identifiers

PMID20974502
PMCPMC2994950

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Registered trials

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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.