Evidence map›Paper›PMID 17922559›Full record

Trial reportClinical pharmacokinetics2007

Effect of highly active antiretroviral therapy on tacrolimus pharmacokinetics in hepatitis C virus and HIV co-infected liver transplant recipients in the ANRS HC-08 study.

Elina Teicher, Isabelle Vincent, Laurence Bonhomme-Faivre, Chadi Abbara, Aurélie Barrail, Alain Boissonnas, Jean-Charles Duclos-Vallée, Anne-Marie Taburet, Didier Samuel, Daniel Vittecoq

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04319172 (Multicentric Study of Coronavirus Disease 2019), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 9% 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.

NCT04319172 completednot on this mapstarted 2020, after this paper: background citation

Multicentric Study of Coronavirus Disease 2019 (COVID-2019) in Solid Organ Transplant Recipients

TypeobservationalSponsorFundación Pública Andaluza para la gestión de la Investigación en SevillaRan2020 to 2023Enrolled488ConditionsTransplant Recipient, Infections, Coronavirus
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 61 citations in OpenAlex.

  1. Guideline
  2. Article
  3. Drug Interactions between Antimicrobial and Immunosuppressive Agents in Solid Organ Transplant Recipients.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2021
    Review
  4. Article
  5. Review
  6. Observational
  7. Article
  8. Review
  9. Liver transplantation in HCV/HIV positive patients.World journal of gastrointestinal surgery · 2011
    Article
  10. Article
  11. Review
  12. Solid organ transplantation and HIV: A changing paradigm.The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2008
    Article
  13. Review
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 2 institutions in 1 country.

Elina TeicherInternal Medicine and Infectious Diseases Department, Hôpital Paul Brousse, Assistance Publique Hôpitaux de Paris (AP-HP), Paris, France.
Isabelle Vincent
Laurence Bonhomme-Faivre
Chadi Abbara
Aurélie Barrail
Alain Boissonnas
Jean-Charles Duclos-Vallée
Anne-Marie Taburet
Didier Samuel
Daniel Vittecoq
Assistance Publique – Hôpitaux de Paris · FRHôpital Paul-Brousse · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo characterise the interactions between tacrolimus and antiretroviral drug combinations in hepatitis C virus-HIV co-infected patients who had received a liver transplant.

designAn observational, open-label, multiple-dose, two-period, one-sequence design clinical trial in which patients received tacrolimus as an immunosuppressive therapy during the postoperative period and then had an antiretroviral drug regimen added. Tacrolimus pharmacokinetics were evaluated at steady state during these two periods.

methodsFourteen patients participated in the study and seven participated in the intensified pharmacokinetic protocol. Patients were included if they had undergone liver transplantation for end-stage chronic hepatitis C, absence of opportunistic infection, a CD4 cell count of >150 cells/microL and an undetectable HIV plasma viral load (<50 copies/mL) under highly active antiretroviral therapy. During the posttransplantation period, the tacrolimus dose was adjusted according to blood concentrations. When liver function and the tacrolimus dose were stable, antiretroviral therapy was reintroduced.

resultsWhen lopinavir/ritonavir were added to the tacrolimus regimen (seven patients), the tacrolimus dose was reduced by 99% to maintain the tacrolimus concentration within the therapeutic range. Only two patients were treated with nelfinavir, which led to a wide variation in inhibition of tacrolimus metabolism. When efavirenz (four patients) or a nucleoside analogue combination (one patient) was added, very little change in tacrolimus dosing was required.

conclusionThe lopinavir/ritonavir combination markedly inhibited tacrolimus metabolism, whereas the effect of efavirenz was small. Tacrolimus dosing must be optimised according to therapeutic drug monitoring and the antiretroviral drug combination.

Indexed as

Antiretroviral Therapy, Highly ActiveLiver TransplantationAdultAgedAlkynesArea Under CurveBenzoxazinesCD4 Lymphocyte CountCyclopropanesDose-Response Relationship, DrugFemaleGraft RejectionHalf-LifeHepatitis CHIVHIV InfectionsAlkynesBenzoxazinesCyclopropanesefavirenzLopinavirNelfinavirPyrimidinonesRitonavirTacrolimus

Identifiers

PMID17922559
OpenAlexW2131294731

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

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 Socratic graph.