Evidence map›Paper›PMID 30489547›Full record

ArticleTherapeutic drug monitoring2019

Darunavir Population Pharmacokinetic Model Based on HIV Outpatient Data.

Alper Daskapan, Quynh T D Tran, Dario Cattaneo, Cristina Gervasoni, Chiara Resnati, Ymkje Stienstra, Wouter F W Bierman, Jos G W Kosterink, Tjip S van der Werf, Johannes H Proost and 2 more

Abstract read
In one paragraph

Article in Therapeutic drug monitoring, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  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

12 authors.

Alper DaskapanDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
Quynh T D TranDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
Dario CattaneoUnit of Clinical Pharmacology, ASST Fatebenefratelli Sacco University Hospital, Milano.
Cristina GervasoniDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco University Hospital, Milano, Italy.
Chiara ResnatiDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco University Hospital, Milano, Italy.
Ymkje StienstraDepartment of Internal Medicine-Infectious Diseases, University Medical Center Groningen, University of Groningen, Groningen.
Wouter F W BiermanDepartment of Internal Medicine-Infectious Diseases, University Medical Center Groningen, University of Groningen, Groningen.
Jos G W KosterinkDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
Tjip S van der WerfDepartment of Internal Medicine-Infectious Diseases, University Medical Center Groningen, University of Groningen, Groningen.
Johannes H ProostUnit Pharmacokinetics, Toxicology and Targeting, Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands.
Jan-Willem C AlffenaarDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
Daniel J TouwDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDarunavir is a second-generation protease inhibitor and is registered for the treatment of HIV-1 infection. The aim of this study was to develop and validate a darunavir population pharmacokinetic model based on data from daily practice.

methodsData sets were obtained from 2 hospitals: ASST Fatebenefratelli Sacco University Hospital, Italy (hospital A), and University Medical Center Groningen, the Netherlands (hospital B). A pharmacokinetic model was developed using data from the largest data set using the iterative two-stage Bayesian procedure within the MWPharm software package. External validation was conducted using data from the smaller data set with Passing-Bablok regression and Bland-Altman analyses.

resultsIn total, data from 198 patients from hospital A and 170 patients from hospital B were eligible for inclusion. A 1-compartment model with first-order absorption and elimination resulted in the best model. The Passing-Bablok analysis demonstrated a linear correlation between measured concentration and predicted concentration with r = 0.97 (P < 0.05). The predicted values correlated well with the measured values as determined by a Bland-Altman analysis and were overestimated by a mean value of 0.12 mg/L (range 0.23-0.94 mg/L). A total of 98.2% of the predicted values were within the limits of agreement.

conclusionsA robust population pharmacokinetic model was developed, which can support therapeutic drug monitoring of darunavir in daily outpatient settings.

Indexed as

AdultAgedBayes TheoremDarunavirFemaleHIV-1HIV InfectionsHIV Protease InhibitorsHumansItalyMaleMiddle AgedNetherlandsOutpatientsYoung AdultDarunavirHIV Protease Inhibitors

Identifiers

PMID30489547
PMCPMC6358182

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Registered trials

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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.