PMID- 16956905
OWN - NLM
STAT- MEDLINE
DCOM- 20070308
LR  - 20201209
IS  - 0305-7453 (Print)
IS  - 0305-7453 (Linking)
VI  - 58
IP  - 5
DP  - 2006 Nov
TI  - Efavirenz trough levels are not associated with virological failure throughout 
      therapy with 800 mg daily and a rifampicin-containing antituberculosis regimen.
PG  - 1017-23
AB  - OBJECTIVES: To assess the safety and efficacy of efavirenz 800 mg daily in 
      HIV-infected patients with tuberculosis receiving a rifampicin-containing regimen 
      and to analyse whether a relationship exists between efavirenz Cmin and its 
      virological efficacy. METHODS: Prospective, open-labelled study including 
      HIV-infected patients on rifampicin and efavirenz 800 mg daily. Treatment 
      adherence, adverse events (AEs), HIV-RNA levels, CD4 cell counts and efavirenz 
      Cmin during and after finishing rifampicin treatment were evaluated. RESULTS: 
      Eighty patients met the inclusion criteria. A permanent drug withdrawal due to 
      AEs occurred in 10 patients, 5 attributable to efavirenz, and 10 patients were 
      lost to follow-up before the third month. Efavirenz Cmin levels with 800 mg plus 
      rifampicin were similar to those with 600 mg after withdrawing rifampicin. Sixty 
      patients were included in the efficacy analysis, eight experiencing virological 
      failure. No relation was observed between the rate of virological failure and 
      efavirenz Cmin, previous antiretroviral treatment or not, baseline CD4 counts or 
      RNA-HIV. The only variable related to virological failure was irregular adherence 
      [odds ratio, 81 (95% CI: 5-1280); P=0.002]. CONCLUSIONS: Given the lack of a 
      demonstrated relationship between efavirenz Cmin and its efficacy in our study, a 
      firm recommendation cannot be made to always increase the dose to 800 mg/day when 
      concomitantly given with rifampicin, but it seems a cautious approach to maintain 
      the same efavirenz plasma levels as with 600 mg daily without rifampicin. 
      Patients weighing<55 kg and also black, Asian and Hispanic subjects in whom 
      genetic-based increased efavirenz plasma levels and rates of AEs have been 
      observed may benefit from a dose of 600 mg.
FAU - Lopez-Cortes, Luis F
AU  - Lopez-Cortes LF
AD  - Infectious Diseases Service, Hospitales Universitarios, Virgen del Rocio, 
      Seville, Spain. lflopez@telefonica.net
FAU - Ruiz-Valderas, Rosa
AU  - Ruiz-Valderas R
FAU - Ruiz-Morales, Josefa
AU  - Ruiz-Morales J
FAU - Leon, Eva
AU  - Leon E
FAU - de Campos, Antonio Vergara
AU  - de Campos AV
FAU - Marin-Niebla, Ana
AU  - Marin-Niebla A
FAU - Marquez-Solero, Manuel
AU  - Marquez-Solero M
FAU - Lozano, Fernando
AU  - Lozano F
FAU - Valiente, Rebeca
AU  - Valiente R
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20060906
PL  - England
TA  - J Antimicrob Chemother
JT  - The Journal of antimicrobial chemotherapy
JID - 7513617
RN  - 0 (Alkynes)
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Antibiotics, Antitubercular)
RN  - 0 (Benzoxazines)
RN  - 0 (Cyclopropanes)
RN  - 0 (Oxazines)
RN  - 0 (Reverse Transcriptase Inhibitors)
RN  - JE6H2O27P8 (efavirenz)
RN  - VJT6J7R4TR (Rifampin)
SB  - IM
MH  - Adult
MH  - Alkynes
MH  - Anti-HIV Agents/administration & dosage/adverse effects/pharmacokinetics
MH  - Antibiotics, Antitubercular/*administration & dosage/adverse effects
MH  - Benzoxazines
MH  - Cyclopropanes
MH  - Drug Administration Schedule
MH  - Drug Interactions
MH  - Female
MH  - HIV/*isolation & purification
MH  - HIV Infections/*drug therapy/metabolism/microbiology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Mycobacterium tuberculosis/*isolation & purification
MH  - Oxazines/*administration & dosage/adverse effects/pharmacokinetics
MH  - Prospective Studies
MH  - Reverse Transcriptase Inhibitors/classification
MH  - Rifampin/*administration & dosage/adverse effects
MH  - Tuberculosis/*drug therapy/metabolism/virology
EDAT- 2006/09/08 09:00
MHDA- 2007/03/09 09:00
CRDT- 2006/09/08 09:00
PHST- 2006/09/08 09:00 [pubmed]
PHST- 2007/03/09 09:00 [medline]
PHST- 2006/09/08 09:00 [entrez]
AID - dkl357 [pii]
AID - 10.1093/jac/dkl357 [doi]
PST - ppublish
SO  - J Antimicrob Chemother. 2006 Nov;58(5):1017-23. doi: 10.1093/jac/dkl357. Epub 
      2006 Sep 6.