Evidence map›Paper›PMID 12680884›Full record

Trial reportBritish journal of clinical pharmacology2003

Pharmacokinetics of ribavirin in combined interferon-alpha 2b and ribavirin therapy for chronic hepatitis C virus infection.

Akihito Tsubota, Yuichi Hirose, Namiki Izumi, Hiromitsu Kumada

Registry-linked trialOpen access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in British journal of clinical pharmacology, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01289496 (Ribavirin Dose Optimization for the Treatment of Hepatitis C), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.8field-weighted citation impact, top 10% 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.

NCT01289496 phase2completednot on this mapstarted 2011, after this paper: background citation

Ribavirin Dose Optimization for the Treatment of Hepatitis C: A Pilot Study

TypeinterventionalSponsorCentre hospitalier de l'Université de Montréal (CHUM)Ran2011 to 2013Enrolled13ConditionsChronic Hepatitis CArmsPeg-interferon alpha-2a, Ribavirin
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 70 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. Metabolomics in viral hepatitis: advances and review.Frontiers in cellular and infection microbiology · 2023
    Review
  6. Article
  7. Review
  8. Article
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  11. Review
  12. Article
  13. 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

4 authors at 3 institutions in 2 countries.

Akihito TsubotaDepartment of Gastroenterology, Toranomon Hospital and Okinaka Memorial Institute for Medical Research, 2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan. zua05135@nifty.com
Yuichi Hirose
Namiki Izumi
Hiromitsu Kumada
Institute for Medical Research · ARMusashino Red Cross Hospital · JPYamanashi Prefectural Central Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe aim of this study was to clarify the pharmacokinetics of ribavirin and interferon-alpha (IFN-alpha) 2b when administered in combination for 24 weeks and effects of pharmacokinetics of both on treatment outcome in chronic hepatitis C with genotype 1b and high viral load.

methodsIn this multicentre open study, 27 patients received 2-week daily induction therapy followed by 22-week, three-times-a-week maintenance therapy of intramuscular IFN-alpha 2b at a dose of 6 million units and oral ribavirin at 400 mg twice daily for 24 weeks, and followed up for 24 weeks post-treatment. Single- and multiple-dose pharmacokinetic studies were assessed by serial measurements of serum concentrations of both compounds at weeks 1 and 24.

resultsFive patients attained sustained virological response. Serum ribavirin concentrations asymptoted after 4-8 weeks of treatment in all patients. The steady-state concentration correlated significantly with serum ribavirin clearance after multiple dosing (r = -0.875; 95% CI -0.932, -0.721; P < 0.001). Serum concentrations at weeks 4 and 8, Cmax and AUC(0,12 h) after multiple dosing and AUC(0,28 weeks) of ribavirin were significantly higher in sustained virological responders than in virological responders or nonresponders (P < 0.05, each). Increased Cmax and accumulation index of AUC(0,12 h) (median 10.5; 95% CI 6.4, 12.4), and prolonged washout half-life after multiple dosing reflected accumulation and slow clearance of ribavirin from the tissue compartments.

conclusionsContinuous exposure and accumulation of ribavirin may be necessary for sustained virological response to combination therapy in chronic hepatitis C with genotype 1b and high viral load.

Indexed as

AdultAntiviral AgentsDose-Response Relationship, DrugDrug Therapy, CombinationFemaleHepatitis C, ChronicHumansInterferon-alphaInterferon alpha-2MaleMiddle AgedRecombinant ProteinsRibavirinTreatment OutcomeViral LoadAntiviral AgentsInterferon-alphaInterferon alpha-2Recombinant ProteinsRibavirin

Identifiers

PMID12680884
PMCPMC1884236
OpenAlexW1572917101

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.