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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Pharmacokinetics of rifampin and isoniazid in tuberculosis-hivcoinfected patients receiving nevirapine-or efavirenz-based antiretroviral treatment
Antimicrobial Agents and Chemotherapy, Volume 58, No. 6, Year 2014
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Description
This is a substudy of the Agence Nationale de Recherches sur le Sida et les Hépatites Virales (ANRS) Comparison of Nevirapine and Efavirenz for the Treatment of HIV-TB Co-infected Patients (ANRS 12146-CARINEMO) trial, which assessed the pharmacokinetics of rifampin or isoniazid with or without the coadministration of nonnucleoside reverse transcriptase inhibitor-based HIV antiretroviral therapy in HIV-tuberculosis-coinfected patients in Mozambique. Thirty-eight patients on antituberculosis therapy based on rifampin and isoniazid participated in the substudy (57.9% males; median age, 33 years; median weight, 51.9 kg; median CD4+ T cell count, 104 cells/μl; median HIV-1 RNA load, 5.5 log copies/ml). The daily doses of rifampin and isoniazid were 10 and 5 mg/kg of body weight, respectively. Twenty-one patients received 200 mg of nevirapine twice a day (b.i.d.), and 17 patients received 600 mg of efavirenz once a day (q.d.) in combination with lamivudine and stavudine from day 1 until the end of the study. Blood samples were collected at regular time-dosing intervals after morning administration of a fixed-dose combination of rifampin and isoniazid. When rifampin was administered alone, the median maximum concentration of drug in serum (Cmax) and the area under the concentration-time curve (AUC) at steady state were 6.59 mg/liter (range, 2.70 to 14.07 mg/ liter) and 27.69 mg.h/liter (range, 11.41 to 109.75 mg.h/liter), respectively. Concentrations remained unchanged when rifampin was coadministered with nevirapine or efavirenz. When isoniazid was administered alone, the median isoniazid Cmax and AUC at steady state were 5.08 mg/liter (range, 1.26 to 11.51 mg/liter) and 20.92 mg.h/liter (range, 7.73 to 56.95 mg.h/liter), respectively. Concentrations remained unchanged when isoniazid was coadministered with nevirapine; however, a 29% decrease in the isoniazid AUC was observed when isoniazid was combined with efavirenz. The pharmacokinetic parameters of rifampin and isoniazid when coadministered with nevirapine or efavirenz were not altered to a clinically significant extent in these severely immunosuppressed HIV-infected patients. Patients experienced favorable clinical outcomes. (This study has been registered at ClinicalTrials.gov under registration no. NCT00495326.) © 2014, American Society for Microbiology.
Authors & Co-Authors
Bhatt, Nilesh B.
Mozambique, Maputo
Instituto Nacional de Saude Maputo
Brazil, Rio de Janeiro
Instituto Nacional de Infectologia Evandro Chagas Ini
Barau, Caroline
France, Le Kremlin-bicetre
Hopital de Bicetre
Amin, A.
France, Le Kremlin-bicetre
Hopital de Bicetre
Baudin, Elisabeth
France, Paris
Epicentre
Meggi, Bindiya
Mozambique, Maputo
Instituto Nacional de Saude Maputo
Baptista da Silva, Carlota
France, Paris
Epicentre
Furlan, Valérie
France, Le Kremlin-bicetre
Hopital de Bicetre
Grinsztejn, Beatriz Gilda Jegerhorn
Brazil, Rio de Janeiro
Instituto Nacional de Infectologia Evandro Chagas Ini
Barrail-Tran, Aurélie
France, Le Kremlin-bicetre
Hopital de Bicetre
France, Saint-aubin
Barrières Physiologiques et Réponses Thérapeutiques
Bonnet, Maryline M.B.
France, Paris
Epicentre
Taburet, Anne Marie
France, Le Kremlin-bicetre
Hopital de Bicetre
Statistics
Citations: 11
Authors: 11
Affiliations: 5
Identifiers
Doi:
10.1128/AAC.02379-13
ISSN:
00664804
e-ISSN:
10986596
Research Areas
Infectious Diseases
Study Locations
Mozambique