Evidence map›Paper›PMID 22392423›Full record

ArticlePharmacotherapy2012

Acceptable plasma concentrations of raltegravir and etravirine when administered by gastrostomy tube in a patient with advanced multidrug-resistant human immunodeficiency virus infection.

Uriel Sandkovsky, Susan Swindells, Ryan Moore, Edward P Acosta, Courtney V Fletcher

Open access · greenAbstract readCase Reports
In one paragraph

Article in Pharmacotherapy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 26% 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, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Quantification of nine antiretroviral drugs in cerebrospinal fluid: An approach to overcome sample collection tube adsorption.Journal of chromatography. B, Analytical technologies in the biomedical and life sciences · 2023
    Article
  4. Review
  5. Article
  6. 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

5 authors at 3 institutions in 1 country.

Uriel SandkovskyDivision of Infectious Diseases, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska 68198-8106, USA. usandkovsky@unmc.edu
Susan Swindells
Ryan Moore
Edward P Acosta
Courtney V Fletcher
University of Nebraska Medical Center · USNebraska Medical Center · USUniversity of Alabama at Birmingham · US

Funding

AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
Pharmacokinetics and Drug-Drug InteractionsP01DA028555 · NIDA · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI ALNOUTI, YAZEN · 2010 to 2019
$16.8M
Virological Measurements of Cryptic ReplicationP01AI074340 · NIAID · UNIVERSITY OF MINNESOTA · PI SCHACKER, TIMOTHY W · 2008 to 2012
$12.1M
NIAID NIH HHS P01 AI074340NIAID NIH HHS P01AI074340NIAID NIH HHS U01 AI068632NIAID NIH HHS U01 AI068636NIAID NIH HHS UO1 AI68632NIAID NIH HHS UO1 AI68636NIDA NIH HHS P01 DA028555NIDA NIH HHS P01DA028555
6 · The paper itself

Abstract

STUDY

objectiveTo determine whether the absorption of four antiretroviral agents-raltegravir, etravirine, emtricitabine, and tenofovir-is compromised when administered by gastrostomy tube.

designPharmacokinetic analysis.

settingUniversity medical center. PATIENT: A 52-year-old African-American man coinfected with advanced multidrug-resistant human immunodeficiency virus (HIV) and chronic hepatitis B, who was receiving treatment with raltegravir, etravirine, emtricitabine, and tenofovir, and developed ulcerative esophagitis with perforation, requiring a gastrostomy tube. MEASUREMENTS AND MAIN

resultsDue to the patient's esophageal perforations, all nutrition and drug therapy had to be provided by gastrostomy tube. As his antiretroviral regimen of raltegravir, etravirine, and emtricitabine-tenofovir was not available in liquid or powder formulations, the oral tablets were crushed or dispersed and mixed with water, then administered by gastrostomy tube. To ensure that the absorption of the drugs was sufficient for antiretroviral response, plasma samples were collected at 2 hours and 12 hours after dosing, and drug concentrations were quantitated by using validated assays. The 2- and 12-hour postdose plasma concentrations were 1220 and 446 ng/ml for raltegravir, 212 and 274 ng/ml for etravirine, 1148 and 164 ng/ml for emtricitabine, and 320 and 94 ng/ml for tenofovir, respectively. The patient's plasma concentrations were then compared with those in published pharmacokinetic studies of oral regimens administered to HIV-infected persons and healthy volunteers. Overall, the plasma concentrations of the antiretrovirals administered by gastrostomy tube were similar to published values. No drug toxicities were observed in this patient.

conclusionThese pharmacokinetic data suggest that absorption of raltegravir, etravirine, emtricitabine, and tenofovir was not compromised when the drugs were administered by gastrostomy tube. These findings provide a basis for further investigation of the pharmacokinetics, safety, tolerance, and antiretroviral response to raltegravir, etravirine, and emtricitabine-tenofovir when the oral route of administration is not possible.

Indexed as

GastrostomyDrug InteractionsDrug Resistance, MultipleDrug Therapy, CombinationHIV InfectionsHumansMaleMiddle AgedNitrilesPyridazinesPyrimidinesPyrrolidinonesRaltegravir PotassiumetravirineNitrilesPyridazinesPyrimidinesPyrrolidinonesRaltegravir Potassium

Identifiers

PMID22392423
PMCPMC3711779
OpenAlexW2077535491

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.