Evidence map›Paper›PMID 26459906›Full record

ArticleAntimicrobial agents and chemotherapy2016

Drug Interactions with the Direct-Acting Antiviral Combination of Ombitasvir and Paritaprevir-Ritonavir.

Prajakta S Badri, Sandeep Dutta, Haoyu Wang, Thomas J Podsadecki, Akshanth R Polepally, Amit Khatri, Jiuhong Zha, Yi-Lin Chiu, Walid M Awni, Rajeev M Menon

Open access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
4.6field-weighted citation impact, top 4% 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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Observational
  5. Article
  6. Article
  7. Clinical Pharmacokinetics of Dasabuvir.Clinical pharmacokinetics · 2017
    Review
  8. Clinical Pharmacokinetics of Ombitasvir.Clinical pharmacokinetics · 2017
    Review
  9. Clinical Pharmacokinetics of Paritaprevir.Clinical pharmacokinetics · 2017
    Review
  10. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. Review
  17. Pharmacologic Considerations in the Treatment of Hepatitis C Virus in Persons With HIV.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016
    Review
  18. 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

10 authors at 1 institution in 1 country.

Prajakta S BadriDepartment of Clinical Pharmacology and Pharmacometrics, AbbVie, Inc., North Chicago, Illinois, USA prajakta.badri@abbvie.com.
Sandeep DuttaDepartment of Clinical Pharmacology and Pharmacometrics, AbbVie, Inc., North Chicago, Illinois, USA.
Haoyu WangDepartment of Clinical Pharmacology and Pharmacometrics-Biometrics, AbbVie, Inc., North Chicago, Illinois, USA.
Thomas J PodsadeckiInfectious Disease Development, AbbVie, Inc., North Chicago, Illinois, USA.
Akshanth R PolepallyDepartment of Clinical Pharmacology and Pharmacometrics, AbbVie, Inc., North Chicago, Illinois, USA.
Amit KhatriDepartment of Clinical Pharmacology and Pharmacometrics, AbbVie, Inc., North Chicago, Illinois, USA.
Jiuhong ZhaDepartment of Clinical Pharmacology and Pharmacometrics, AbbVie, Inc., North Chicago, Illinois, USA.
Yi-Lin ChiuDepartment of Clinical Pharmacology and Pharmacometrics-Biometrics, AbbVie, Inc., North Chicago, Illinois, USA.
Walid M AwniDepartment of Clinical Pharmacology and Pharmacometrics, AbbVie, Inc., North Chicago, Illinois, USA.
Rajeev M MenonDepartment of Clinical Pharmacology and Pharmacometrics, AbbVie, Inc., North Chicago, Illinois, USA.
AbbVie (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The two direct-acting antiviral (2D) regimen of ombitasvir and paritaprevir (administered with low-dose ritonavir) is being developed for treatment of genotype subtype 1b and genotypes 2 and 4 chronic hepatitis C virus (HCV) infection. Drug-drug interactions were evaluated in healthy volunteers to develop dosing recommendations for HCV-infected subjects. Mechanism-based interactions were evaluated for ketoconazole, pravastatin, rosuvastatin, digoxin, warfarin, and omeprazole. Interactions were also evaluated for duloxetine, escitalopram, methadone, and buprenorphine-naloxone. Ratios of geometric means with 90% confidence intervals for the maximum plasma concentration and the area under the plasma concentration-time curve were estimated to assess the magnitude of the interactions. For most medications, coadministration with the 2D regimen resulted in a <50% change in exposures. Ketoconazole, digoxin, pravastatin, and rosuvastatin exposures increased by up to 105%, 58%, 76%, and 161%, respectively, and omeprazole exposures decreased by approximately 50%. Clinically meaningful changes in ombitasvir, paritaprevir, or ritonavir exposures were not observed. In summary, all 11 medications evaluated can be coadministered with the 2D regimen, with most medications requiring no dose adjustment. Ketoconazole, digoxin, pravastatin, and rosuvastatin require lower doses, and omeprazole may require a higher dose. No dose adjustment is required for the 2D regimen.

Indexed as

AdultAnilidesAntacidsAnti-Arrhythmia AgentsAnticoagulantsAntidepressive AgentsAntifungal AgentsAntiviral AgentsArea Under CurveCarbamatesCyclopropanesDrug InteractionsDrug Therapy, CombinationFemaleHealthy VolunteersHumansAnilidesAntacidsAnti-Arrhythmia AgentsAnticoagulantsAntidepressive AgentsAntifungal AgentsAntiviral AgentsCarbamatesCyclopropanesHydroxymethylglutaryl-CoA Reductase InhibitorsLactams, MacrocyclicMacrocyclic CompoundsNarcotic AntagonistsombitasvirparitaprevirProlineRitonavirSulfonamidesValine

Identifiers

PMID26459906
PMCPMC4704150
OpenAlexW2202569540

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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.