Evidence map›Paper›PMID 18467305›Full record

Trial reportThe Journal of antimicrobial chemotherapy2008

Pharmacokinetic analysis to assess forgiveness of boosted saquinavir regimens for missed or late dosing.

Laura Dickinson, Marta Boffito, Saye H Khoo, Malte Schutz, Leon J Aarons, Anton L Pozniak, David J Back

Open access · bronzeAbstract readClinical TrialComparative Study
In one paragraph

Trial report in The Journal of antimicrobial chemotherapy, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.0field-weighted citation impact, top 25% 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

7 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Quantification of the Forgiveness of Drugs to Imperfect Adherence.CPT: pharmacometrics & systems pharmacology · 2015
    Article
  7. 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

7 authors at 4 institutions in 3 countries.

Laura DickinsonDepartment of Pharmacology, University of Liverpool, Liverpool, UK. laurad@liv.ac.uk
Marta Boffito
Saye H Khoo
Malte Schutz
Leon J Aarons
Anton L Pozniak
David J Back
University of Liverpool · GBChelsea and Westminster Hospital NHS Foundation Trust · GBRoche (Switzerland) · CHUniversity of Manchester · GB

Funding

Wellcome Trust 083851
6 · The paper itself

Abstract

objectivesOne potential concern of once-daily protease inhibitor administration is low trough concentrations and ultimately the 'forgiveness' or robustness in comparison with the originally licensed twice-daily dose. To give an estimation of 'forgiveness', we determined the length of time plasma drug concentrations were below target in HIV-infected patients receiving saquinavir/ritonavir regimens.

methodsSeventy-seven pharmacokinetic profiles (saquinavir/ritonavir 1000/100 mg twice daily, n = 34; 1600/100 mg once daily, n = 26; 2000/100 mg once daily, n = 17) from five studies were combined, presented as twice- and once-daily percentiles (P10-P90) and compared. At percentiles where trough concentrations fell below the alleged minimum effective concentration (MEC; 100 ng/mL), the length of time below MEC was determined.

resultsSaquinavir concentrations were below MEC at P10 for 0.7 h for twice-daily saquinavir/ritonavir when compared with 8.6 and 6.6 h for 1600/100 and 2000/100 mg once daily, respectively. At P25, 1600/100 mg once daily produced suboptimal concentrations for 5.5 h in contrast to 0.5 h for 2000/100 mg once daily.

conclusionsHere, we provide substantive data that indicate once-daily saquinavir, in particular 1600/100 mg, is not as robust as the twice-daily regimen based on a population of UK patients; this raises concern over late or missed doses. However, pharmacokinetic data can only ever be a guide to the impact on long-term efficacy.

Indexed as

Acquired Immunodeficiency SyndromeAdultFemaleHumansMaleMiddle AgedPlasmaRitonavirSaquinavirTime FactorsUnited KingdomRitonavirSaquinavir

Identifiers

PMID18467305
PMCPMC3672987
OpenAlexW2139319499

What OpenQuestion holds

Textmetadata
LicenceTDM
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.