Evidence map›Paper›PMID 15685543›Full record

Trial reportGastroenterology2005

Viral kinetics in hepatitis C or hepatitis C/human immunodeficiency virus-infected patients.

Kenneth E Sherman, Norah J Shire, Susan D Rouster, Marion G Peters, Margaret James Koziel, Raymond T Chung, Paul S Horn

Registry-linked trialAbstract readClinical TrialMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Gastroenterology, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00008463 (A Prospective, Multicenter, Phase II/III, Open-Label, Controlled, Randomized Trial Evaluating the Efficacy, Safety, and Tolerability of Interferon-alfa-2a Plus Ribavirin Versus PEG-interferon-alfa-2a Plus Ribavirin for Chronic Hepatitis C Virus), which is not on this map. Cited by 26 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 3 pooled it
–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.

NCT00008463 phase2completednot on this map

A Prospective, Multicenter, Phase II/III, Open-Label, Controlled, Randomized Trial Evaluating the Efficacy, Safety, and Tolerability of Interferon-alfa-2a Plus Ribavirin Versus PEG-interferon-alfa-2a Plus Ribavirin for Chronic Hepatitis C Virus (HCV) Infection in Individuals Co-Infected With Human Immunodeficiency Virus-1 (HIV-1)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2000 to 2006Enrolled132ConditionsHIV Infections, Hepatitis CArmsRibavirin, Interferon alfa-2a, Peginterferon alfa-2a
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. HCV Council--critical appraisal of data: recommendations for clinical practice in a rapidly evolving therapeutic landscape.Liver international : official journal of the International Association for the Study of the Liver · 2016
    Guideline
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Patterns and characteristics of hepatitis C transmission clusters among HIV-positive and HIV-negative individuals in the Australian trial in acute hepatitis C.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2011
    Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. HIV coinfection with hepatitis C virus: evolving epidemiology and treatment paradigms.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2012
    Review
  18. Review
  19. Article
  20. 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

7 authors.

Kenneth E ShermanDepartment of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH 45267, USA. Kenneth.sherman@uc.edu
Norah J Shire
Susan D Rouster
Marion G Peters
Margaret James Koziel
Raymond T Chung
Paul S Horn

Funding

WOMEN'S HEALTH AGENDAU01AI025897 · NIAID · UNIVERSITY OF CINCINNATI · PI FEINBERG, JUDITH E · 1987 to 2006
$12.5M
HCV Genomic Variability in HIV Infected HemophiliacsR01AI049508 · NIAID · UNIVERSITY OF CINCINNATI · PI SHERMAN, KENNETH E · 2001 to 2004
$2.9M
NIAID NIH HHS AI25897NIAID NIH HHS AI49508NIAID NIH HHS R01 AI049508NIAID NIH HHS U01 AI025897
6 · The paper itself

Abstract

BACKGROUND AND

aimsKinetic modeling of hepatitis C virus (HCV) response to interferon (IFN)-based therapy provides insights into factors associated with treatment outcomes. HCV/human immunodeficiency virus (HIV)-co-infected patients show lower response rates vs. HCV-monoinfected patients. Reasons for this remain unclear. This study evaluated kinetic parameters and treatment responses in co-infected vs monoinfected patients.

methodsCo-infected patients were randomized within a US multicenter trial (ACTG 5071) to receive pegylated-interferon (PEG-IFN) alfa-2a + ribavirin vs. IFN alfa-2a + ribavirin. Monoinfected controls were matched prospectively for treatment, genotype, age, sex, race, and histology. Quantitative HCV-RNA testing was performed at hours 0, 6, 12, 24, 48, and 72; days 7, 10, 14, 28, and 56; and weeks 12, 24, 48, and 72.

resultsTwelve HCV/HIV-co-infected and 15 HCV-monoinfected patients underwent viral kinetic sampling. Among HIV-positive patients the mean CD4(+) count was 325 cells/mm(3). Seventy-five percent of patients were genotype 1. The HCV-RNA level was undetectable at 72 weeks in 25% and 40% of co-infected and monoinfected patients, respectively. Phase 1/2 declines, free virus clearance rate, and infected hepatocyte death rate were not affected by co-infection status but differed by treatment. Efficiency (epsilon) > or = 90% at 60 hours was associated with viral clearance ( P = .02). Modeling with pooled parameters suggests baseline viral load is a key factor in time to response in this cohort. Predicted clearance time increased by 28% in co-infected patients.

conclusionsCo-infection status did not affect key kinetic parameters. Among kinetic parameters, efficiency was associated significantly with viral clearance. Co-infected patients may require longer treatment duration than monoinfected patients given their generally higher baseline viral loads.

Indexed as

AdultAntiviral AgentsFemaleGenotypeHepacivirusHepatitis CHIV InfectionsHumansInterferon-alphaInterferon alpha-2KineticsMaleMiddle AgedPolyethylene GlycolsRecombinant ProteinsRibavirinAntiviral AgentsInterferon-alphaInterferon alpha-2peginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsRibavirinRNA, Viral

Identifiers

PMID15685543
PMCPMC4036101

What OpenQuestion holds

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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.