Evidence map›Paper›PMID 32808306›Full record

ArticleBritish journal of clinical pharmacology2021

Pharmacologic effects of oseltamivir in immunocompromised adult patients as assessed by population PK/PD analysis and drug-disease modelling for dosing regimen optimization.

Stefan Sturm, Annabelle Lemenuel-Diot, Kashyap Patel, Leonid Gibiansky, Rajinder Bhardwaj, Patrick F Smith, Steve Dang, Elke Zwanziger, Clare Nasmyth-Miller, Patanjali Ravva

Open access · hybridAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 34% 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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Review
  3. 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 4 institutions in 3 countries.

Stefan SturmRoche Innovation Center Basel, Roche Pharmaceutical Research and Early Development, Basel, Switzerland.ORCID 0000-0003-4866-823X
Annabelle Lemenuel-DiotRoche Innovation Center Basel, Roche Pharmaceutical Research and Early Development, Basel, Switzerland.
Kashyap PatelCertara, Princeton, NJ, USA.
Leonid GibianskyQuantPharm LLC, North Potomac, MD, USA.
Rajinder BhardwajCertara, Princeton, NJ, USA.
Patrick F SmithCertara, Princeton, NJ, USA.ORCID 0000-0002-6003-0805
Steve DangRoche Innovation Center New York, Roche Pharmaceutical Research and Early Development, New York, NY, USA.
Elke ZwanzigerRoche Innovation Center Basel, Roche Pharmaceutical Research and Early Development, Basel, Switzerland.
Clare Nasmyth-MillerRoche Products Ltd, Welwyn Garden City, Hertfordshire, UK.
Patanjali RavvaRoche Innovation Center New York, Roche Pharmaceutical Research and Early Development, New York, NY, USA.
Roche (Switzerland) · CHCertara (United States) · USRoche (United Kingdom) · GBUniversity of the Potomac · US

Funding

F. Hoffmann-La Roche Ltd.Hoffmann-La Roche Ltd
6 · The paper itself

Abstract

aimPharmacologic effects were analysed to determine a dose recommendation for oseltamivir in immunocompromised (IC) adults with influenza.

methodsQuantitative clinical pharmacology methods were applied to data from 160 adult IC patients (aged 18-78 years) from two studies (NV20234, 150 patients; NV25118, 10 patients) who received oseltamivir 75-200 mg twice daily for up to 10 days. An established population-pharmacokinetic (PK) model with additional effects on oseltamivir and oseltamivir carboxylate (OC) clearance described the PK characteristics of oseltamivir in IC patients versus otherwise healthy (OwH) patients from previous clinical trials. Estimated PK parameters were used to evaluate exposure-response relationships for virologic endpoints (time to cessation of viral shedding, viral load measures and treatment-emergent resistance). A drug-disease model characterized the viral kinetics of influenza accounting for the effect of OC on viral production.

resultsOseltamivir clearance was 32.5% lower (95% confidence interval [CI], 26.1-38.8) and OC clearance was 33.7% lower (95% CI, 23.2-44.1) in IC versus OwH patients. No notable exposure-response relationships were identified for exposures higher than those achieved after conventional dose oseltamivir 75 mg, which appeared to be close to the maximum effect of oseltamivir. Simulations of the drug-disease model predicted that initiating treatment within 48 hours of symptom onset had maximum impact, and a treatment duration of 10 days was favourable over 3-5 days to limit viral rebound.

conclusionsOur findings support the use of conventional-dose oseltamivir 75 mg twice daily for 10 days in the treatment of IC adult patients with influenza.

Indexed as

Influenza, HumanPharmaceutical PreparationsAdultAntiviral AgentsHumansOseltamivirVirus SheddingAntiviral AgentsOseltamivirPharmaceutical Preparationsclinical trialsimmunosuppressionmodelling and simulationpharmacokinetic-pharmacodynamicpopulation analysis

Identifiers

PMID32808306
PMCPMC8246794
OpenAlexW3070761910

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.