Evidence map›Paper›PMID 16189072›Full record

Trial reportAntimicrobial agents and chemotherapy2005

Effect of ribavirin on intracellular and plasma pharmacokinetics of nucleoside reverse transcriptase inhibitors in patients with human immunodeficiency virus-hepatitis C virus coinfection: results of a randomized clinical study.

M Rodriguez-Torres, F J Torriani, V Soriano, M J Borucki, E Lissen, M Sulkowski, D Dieterich, K Wang, J-M Gries, P G Hoggard and 1 more

Open access · greenAbstract readClinical TrialComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
4.2field-weighted citation impact, top 5% 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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Pharmacokinetics of ribavirin in patients with hepatitis C virus.British journal of clinical pharmacology · 2006
    Pooled it
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Specific targeted antiviral therapy for hepatitis C.Current gastroenterology reports · 2007
    Review
  9. Review
  10. Review
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 at 10 institutions in 5 countries.

M Rodriguez-TorresFundacion de Investigación de Diego, Santurce, Puerto Rico. fdciondeinvest@aol.com
F J Torriani
V Soriano
M J Borucki
E Lissen
M Sulkowski
D Dieterich
K Wang
J-M Gries
P G Hoggard
D Back
University of Liverpool · GBHospital Clínico San Carlos · ESHospital Universitario Virgen del Rocío · ESIcahn School of Medicine at Mount Sinai · USJohns Hopkins Medicine · USLa Roche College · USPuerto Rico Community Foundation · PRRoche (Switzerland) · CHThe University of Texas Health Science Center at Tyler · USUniversity of California, San Diego · US

Funding

Management/Hepatitis C/HIV-infected and Uninfected IDU'sR01DA016065 · NIDA · JOHNS HOPKINS UNIVERSITY · PI SULKOWSKI, MARK SEBASTIAN · 2003 to 2018
$8.0M
6 · The paper itself

Abstract

The intracellular triphosphorylation and plasma pharmacokinetics of lamivudine (3TC), stavudine (d4T), and zidovudine (ZDV) were assessed in a pharmacokinetic substudy, in 56 human immunodeficiency virus-hepatitis C virus (HIV-HCV) coinfected patients receiving peginterferon alfa-2a (40KD) 180 microg/week plus either placebo or ribavirin (RBV) 800 mg/day in the AIDS PEGASYS Ribavirin International Coinfection Trial. There were no significant differences between patients treated with RBV and placebo in plasma pharmacokinetics parameters for the nucleoside reverse transcriptase inhibitors (NRTIs) at steady state (weeks 8 to 12): ratios of least squares mean of area under the plasma concentration-time curve (AUC(0-12 h)) were 1.17 (95% confidence interval, 0.91 to 1.51) for 3TC, 1.44 (95% confidence interval, 0.58 to 3.60) for d4T and 0.85 (95% confidence interval, 0.50 to 1.45) for ZDV, and ratios of least squares mean plasma C(max) were 1.33 (95% confidence interval, 0.99 to 1.78), 1.06 (95% confidence interval, 0.68 to 1.65), and 0.84 (95% confidence interval, 0.46 to 1.53), respectively. Concentrations of NRTI triphosphate (TP) metabolites in relation to those of the triphosphates of endogenous deoxythymidine-triphosphate (dTTP) and deoxcytidine-triphosphate (dCTP) were similar in the RBV and placebo groups. Differences (RBV to placebo) in least squares mean ratios of AUC(0-12 h) at steady state were 0.274 (95% confidence interval, -0.37 to 0.91) for 3TC-TP:dCTP, 0.009 (95% confidence interval, -0.06 to 0.08) for d4T-TP:dTTP, and -0.081 (95% confidence interval, -0.40 to 0.24) for ZDV-TP:dTTP. RBV did not adversely affect HIV-1 replication. In summary, RBV 800 mg/day administered in combination with peginterferon alfa-2a (40KD) does not significantly affect the intracellular phosphorylation or plasma pharmacokinetics of 3TC, d4T, and ZDV in HIV-HCV-coinfected patients.

Indexed as

AdultArea Under CurveDrug Therapy, CombinationFemaleHepacivirusHepatitis CHIV-1HIV InfectionsHumansInterferon-alphaInterferon alpha-2LamivudineMaleMiddle AgedPolyethylene GlycolsRecombinant ProteinsInterferon-alphaInterferon alpha-2Lamivudinepeginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsReverse Transcriptase InhibitorsRibavirinStavudineZidovudine

Identifiers

PMID16189072
PMCPMC1251509
OpenAlexW2111790487

What OpenQuestion holds

Textmetadata
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.