Evidence map›Paper›PMID 25239466›Full record

ArticleThe Journal of antimicrobial chemotherapy2015

Nevirapine or efavirenz for tuberculosis and HIV coinfected patients: exposure and virological failure relationship.

Nilesh B Bhatt, Elisabeth Baudin, Bindiya Meggi, Carlota da Silva, Aurélie Barrail-Tran, Valérie Furlan, Beatriz Grinsztejn, Maryline Bonnet, Anne-Marie Taburet, ANRS 12146/12214-CARINEMO Study Group

Open access · bronzeAbstract read
In one paragraph

Article in The Journal of antimicrobial chemotherapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
1.4field-weighted citation impact, top 18% 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

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Review
  8. Article
  9. Frontiers in pharmacology · 2020
    Article
  10. Article
  11. Tuberculosis Associated with HIV Infection.Microbiology spectrum · 2017
    Review
  12. Article
  13. The pregnane X receptor in tuberculosis therapeutics.Expert opinion on drug metabolism & toxicology · 2016
    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 6 institutions in 3 countries.

Nilesh B BhattInstituto Nacional de Saúde, Ministry of Health, Maputo, Mozambique Instituto de Pesquisa Clínica Evandro Chagas, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil nbhatt.mz@gmail.com.
Elisabeth BaudinEpicentre, Paris, France.
Bindiya MeggiInstituto Nacional de Saúde, Ministry of Health, Maputo, Mozambique.
Carlota da SilvaEpicentre, Paris, France.
Aurélie Barrail-TranAssistance Publique Hôpitaux de Paris, Bicêtre Hospital, Hôpitaux Universitaires Paris Sud, Clinical Pharmacy, Paris, France EA4123, Faculty of Pharmacy, University Paris Sud, Paris, France.
Valérie FurlanAssistance Publique Hôpitaux de Paris, Bicêtre Hospital, Hôpitaux Universitaires Paris Sud, Clinical Pharmacy, Paris, France.
Beatriz GrinsztejnInstituto de Pesquisa Clínica Evandro Chagas, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
Maryline BonnetEpicentre, Paris, France.
Anne-Marie TaburetAssistance Publique Hôpitaux de Paris, Bicêtre Hospital, Hôpitaux Universitaires Paris Sud, Clinical Pharmacy, Paris, France.
ANRS 12146/12214-CARINEMO Study Group
Assistance Publique – Hôpitaux de Paris · FRBicêtre Hospital · FRFundação Oswaldo Cruz · BRInstituto Evandro Chagas · BRMinistry of Health · MZUniversité Paris-Sud · FR

Funding

The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials)UM1AI069476 · NIAID · FUNDACAO OSWALDO CRUZ · PI BEATRIZ GRINSZTEJN · 2012 to 2026
$26.3M
The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials)U01AI069476 · NIAID · FUNDACAO OSWALDO CRUZ · PI GRINSZTEJN, BEATRIZ · 2008 to 2011
$14.0M
NIAID NIH HHS UM1 AI069476
6 · The paper itself

Abstract

objectivesWe describe nevirapine and efavirenz exposure on and off tuberculosis treatment and consequences for virological efficacy and tolerance in patients included in the ANRS 12146/12214-CARINEMO trial.

methodsParticipants were randomly selected to receive either nevirapine at 200 mg twice daily (n = 256) or efavirenz at 600 mg daily (n = 270), both combined with two nucleoside analogues. Blood samples were drawn 12 h after nevirapine or efavirenz administration, while on tuberculosis treatment and after tuberculosis treatment discontinuation. In 62 participants, samples taken 12 h after drug administration were drawn weekly for the first month of ART. Sixteen participants participated in an extensive pharmacokinetic study of nevirapine. Concentrations were compared with the therapeutic ranges of 3000-8000 ng/mL for nevirapine and 1000-4000 ng/mL for efavirenz.

resultsNevirapine concentrations at the end of the first week of treatment (on antituberculosis drugs) did not differ from concentrations off tuberculosis treatment, but declined thereafter. Concentrations at steady-state were 4111 ng/mL at week 12 versus 6095 ng/mL at week 48 (P < 0.0001). Nevirapine concentrations <3000 ng/mL were found to be a risk factor for virological failure. Efavirenz concentrations were higher on than off tuberculosis treatment (2700 versus 2450 ng/mL, P < 0.0001).

conclusionsThe omission of the 2 week lead-in dose of nevirapine prevented low concentrations at treatment initiation but did not prevent the risk of virological failure. Results support the WHO recommendation to use efavirenz at 600 mg daily in patients on rifampicin-based antituberculosis therapy.

Indexed as

AdultAlkynesAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveAntitubercular AgentsBenzoxazinesCyclopropanesDrug ToleranceFemaleHIV InfectionsHumansMaleMiddle AgedNevirapineTreatment OutcomeTuberculosisAlkynesAnti-HIV AgentsAntitubercular AgentsBenzoxazinesCyclopropanesefavirenzNevirapinedrug–drug interactionsefavirenznevirapineTB/HIV coinfection

Identifiers

PMID25239466
PMCPMC4267502
OpenAlexW2159571963

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.