Evidence map›Paper›PMID 28685397›Full record

Trial reportThe AAPS journal2017

Application of Exposure-Response Analyses to Establish the Pharmacodynamic Similarity of a Once-Daily Regimen to an Approved Twice-Daily Dosing Regimen for the Treatment of HCV Infection.

Akshanth R Polepally, Haoyu Wang, Patrick J Marroum, Mukul Minocha, Balakrishna Hosmane, Amit Khatri, Sven Mensing, Thomas J Podsadecki, Daniel E Cohen, Walid M Awni and 1 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The AAPS journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Akshanth R PolepallyClinical Pharmacokinetics and Pharmacodynamics, AbbVie Inc, North Chicago, Illinois, USA.
Haoyu WangBiometrics, AbbVie Inc, North Chicago, Illinois, USA.
Patrick J MarroumClinical Pharmacokinetics and Pharmacodynamics, AbbVie Inc, North Chicago, Illinois, USA.
Mukul MinochaClinical Pharmacokinetics and Pharmacodynamics, AbbVie Inc, North Chicago, Illinois, USA.
Balakrishna HosmaneBiometrics, AbbVie Inc, North Chicago, Illinois, USA.
Amit KhatriClinical Pharmacokinetics and Pharmacodynamics, AbbVie Inc, North Chicago, Illinois, USA.
Sven MensingClinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co, Ludwigshafen am Rhein, Germany.
Thomas J PodsadeckiInfectious Disease Development, AbbVie Inc, North Chicago, Illinois, USA.
Daniel E CohenInfectious Disease Development, AbbVie Inc, North Chicago, Illinois, USA.
Walid M AwniClinical Pharmacokinetics and Pharmacodynamics, AbbVie Inc, North Chicago, Illinois, USA.
Rajeev M MenonClinical Pharmacokinetics and Pharmacodynamics, AbbVie Inc, North Chicago, Illinois, USA. rajeev.menon@abbvie.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The triple direct-acting antiviral (3-DAA) regimen (two co-formulated tablets of ombitasvir/paritaprevir/ritonavir once daily and one tablet of dasabuvir twice daily) for patients with hepatitis C virus (HCV) genotype 1 infection has been reformulated for once-daily administration containing all three active DAAs (3QD regimen). Two bioequivalence studies compared the 3-DAA and 3QD regimens. In study 1, fed, single-, and multiple-dose crossover comparisons revealed exposures for drug components that were slightly outside the bioequivalence criteria, i.e., 21 to 29% lower dasabuvir C

Indexed as

AdultAntiviral AgentsCross-Over StudiesDrug Administration ScheduleDrug Therapy, CombinationFemaleHepatitis CHumansLogistic ModelsMaleMiddle AgedTherapeutic EquivalencyAntiviral Agents3-DAA regimen3QD regimenHCVsustained virologic response at week 12 post-treatment (SVR12)

Identifiers

What OpenQuestion holds

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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.