Evidence map›Paper›PMID 26869690›Full record

ArticleThe Journal of antimicrobial chemotherapy2016

Plasma and intracellular ribavirin concentrations are not significantly altered by abacavir in hepatitis C virus-infected patients.

Edward J Fuchs, Jennifer J Kiser, Craig W Hendrix, Mark Sulkowski, Christine Radebaugh, Lane Bushman, Michelle L Ray, Adriana Andrade

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in The Journal of antimicrobial chemotherapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01052701 (Pharmacokinetic Interactions of Ribavirin and Abacavir in Hepatitis-C Mono-infected Male Subjects Who Previously Failed Ribavirin-based Treatment), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 44% 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.

NCT01052701 phase1completednot on this map

Pharmacokinetic Interactions of Ribavirin and Abacavir in Hepatitis-C Mono-infected Male Subjects Who Previously Failed Ribavirin-based Treatment

TypeinterventionalSponsorJohns Hopkins UniversityRan2009 to 2012Enrolled26ConditionsHepatitis C, HIVArmsRibavirin, Ribavirin plus Abacavir (ABC)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. 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

8 authors at 2 institutions in 1 country.

Edward J FuchsDepartment of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Jennifer J KiserDepartment of Pharmaceutical Sciences, University of Colorado Denver, Aurora, CO, USA.
Craig W HendrixDepartment of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Mark SulkowskiDepartment of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Christine RadebaughDepartment of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Lane BushmanDepartment of Pharmaceutical Sciences, University of Colorado Denver, Aurora, CO, USA.
Michelle L RayDepartment of Pharmaceutical Sciences, University of Colorado Denver, Aurora, CO, USA.
Adriana AndradeDepartment of Medicine, Johns Hopkins University, Baltimore, MD, USA aandrade@jhmi.edu.
Johns Hopkins University · USUniversity of Colorado Denver · US

Funding

Patient Oriented Research in Hepatitis C-infected Injection Drug UsersK24DA034621 · NIDA · JOHNS HOPKINS UNIVERSITY · PI SULKOWSKI, MARK SEBASTIAN · 2012 to 2022
$1.2M
NIDA NIH HHS K24 DA034621NIDA NIH HHS K24DA034621
6 · The paper itself

Abstract

objectivesThe objective of this study was to evaluate the effects of abacavir on intracellular ribavirin triphosphate and plasma ribavirin trough concentrations.

methodsHepatitis C virus-infected subjects who had been cured or failed prior treatment were randomized to 8 weeks of ribavirin alone (N = 14; weight-based dosing) or weight-based ribavirin + abacavir (N = 14; 300 mg orally every 12 h). Ribavirin trough concentrations were measured on days 14, 28, 42 and 56; PBMCs for ribavirin triphosphate determination were sampled on days 28 and 56, pre-dose and at 6 and 12 h post-dose. ClinicalTrials.gov: NCT01052701.

resultsTwenty-six subjects completed the study (24 males, 17 Caucasians, median age 52 years); 2 were excluded for missed pharmacokinetic visits. Fourteen subjects received ribavirin + abacavir and 12 received ribavirin alone. Mean ± SD plasma ribavirin trough concentrations (μg/mL) on days 14, 28, 42 and 56, respectively, were not significantly different with coadministration of abacavir (1.54 ± 0.60, 1.93 ± 0.54, 2.14 ± 0.73 and 2.54 ± 1.05) compared with ribavirin alone (1.48 ± 0.32, 2.08 ± 0.41, 2.32 ± 0.47 and 2.60 ± 0.62) (P > 0.40). Mean ribavirin triphosphate intracellular concentrations (pmol/10(6) cells) on days 28 and 56, respectively, did not differ statistically between abacavir users (11.98 ± 9.86 and 15.87 ± 12.52) and non-users (15.91 ± 15.58 and 15.93 ± 12.69) (P > 0.4). Adverse events were mild or moderate, except for three grade 3 occurrences of transaminitis, cholecystitis and low absolute neutrophil count that resolved and were judged not attributable to study medications.

conclusionsAbacavir did not significantly alter ribavirin or ribavirin triphosphate concentrations.

Indexed as

AbacavirAdolescentAdultAntiviral AgentsCytosolDideoxynucleosidesFemaleHepatitis C, ChronicHumansMaleMiddle AgedPlasmaProspective StudiesRibavirinTime FactorsYoung AdultAbacavirAntiviral AgentsDideoxynucleosidesRibavirin

Identifiers

PMID26869690
PMCPMC4867100
OpenAlexW2273701262

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.