Evidence map›Paper›PMID 25708713›Full record

ArticleAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2015

Pharmacokinetics and dose recommendations for cyclosporine and tacrolimus when coadministered with ABT-450, ombitasvir, and dasabuvir.

P Badri, S Dutta, E Coakley, D Cohen, B Ding, T Podsadecki, B Bernstein, W Awni, R Menon

Abstract readClinical Trial, Phase I
In one paragraph

Article in American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers.

0numbers the graph read from it
0cells of the map it votes in
43citing 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

43 citing papers in PubMed.

  1. Article
  2. Article
  3. Observational
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. "Saving lives with nirmatrelvir/ritonavir one transplant patient at a time".Transplant infectious disease : an official journal of the Transplantation Society · 2023
    Review
  11. Review
  12. Article
  13. Early clinical experience with nirmatrelvir/ritonavir for the treatment of COVID-19 in solid organ transplant recipients.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2022
    Article
  14. Article
  15. Observational
  16. Article
  17. Article
  18. Review
  19. Review
  20. Observational
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

9 authors.

P BadriAbbVie Inc., North Chicago, IL.
S Dutta
E Coakley
D Cohen
B Ding
T Podsadecki
B Bernstein
W Awni
R Menon

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

ABT-450, ombitasvir, and dasabuvir are direct-acting antiviral agents (DAAs) that have been developed for combination treatment of chronic hepatitis C virus (HCV) infection. Because these DAAs have metabolic and transporter profiles that overlap with cyclosporine and tacrolimus disposition, there is potential for drug interactions. Two Phase 1 studies assessed effects of ABT-450 (150 mg coadministered with ritonavir 100 mg once daily), ombitasvir (25 mg once daily), and dasabuvir (400 mg twice daily) on the pharmacokinetics, safety, and tolerability of a single dose of cyclosporine (30 mg) or tacrolimus (2 mg) in healthy volunteers (N = 12 per study). In the presence of steady-state concentrations of all 3 DAAs, dose-normalized cyclosporine concentration at 24 hours (C₂₄), and area under the concentration-time curve from time 0 to infinity (AUC(∞)) were 15.8-fold and 5.8-fold, respectively, and dose-normalized tacrolimus C₂₄ and AUC(∞) were 17-fold and 57-fold, respectively, of either agent alone. Cyclosporine and tacrolimus half-lives increased from 7 to 25 h and 32 to 232 h, respectively. There were no major safety or tolerability issues in these studies. The results suggest that cyclosporine and tacrolimus doses and dosing frequency should be reduced in HCV-infected posttransplant patients being treated with this 3-DAA regimen.

Indexed as

2-NaphthylamineAdolescentAdultAnilidesAntiviral AgentsArea Under CurveCarbamatesCyclopropanesCyclosporineDrug Administration ScheduleFemaleHealthy VolunteersHepacivirusHepatitis CHumansLactams, Macrocyclic2-NaphthylamineAnilidesAntiviral AgentsCarbamatesCyclopropanesCyclosporinedasabuvirLactams, MacrocyclicMacrocyclic CompoundsombitasvirparitaprevirProlineSulfonamidesTacrolimusUracilValinecalcineurin inhibitor: cyclosporine A (CsA)calcineurin inhibitor: tacrolimusclinical research/practiceimmunosuppressantinfection and infectious agentsinfectious diseaseliver transplantation/hepatologypharmacokinetics/pharmacodynamicspharmacologyviral: hepatitis C

Identifiers

PMID25708713
PMCPMC5024008

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.