Single Dose Pharmacokinetics of Efavirenzin Healthy Indian Subjects

Ramachandran, Geetha and Hemanth Kumar, A K and Sukumar, B and Kumaraswami, V and Swaminathan, Soumya (2007) Single Dose Pharmacokinetics of Efavirenzin Healthy Indian Subjects. SAARC Journal of Tuberculosis, Lung Disease and HIV/AIDS , IV (1). pp. 38-43. ISSN Print: 818-9741; Online: 2091-0959

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Abstract

Background & Objective: Access to antiretroviral therapy in India is improving. Efavirenz (EFV) is a commonly used non-nucleoside reverse transcriptase inhibitor used to treat HIV infection. No information is available on the pharmacokinetics of EFV in Indian subjects. The aim of this study was to obtain information on single dose pharmacokinetics of efavirenz (EFV) in healthy Indian subjects. Methods: Sixteen adult healthy volunteers (8 males and 8 females) were administered a single oral tablet of 600 mg EFV after an overnight fast. Blood samples were collected at 1, 2, 3, 4, 5, 6, 10, 24 and 48 hours post dosing. Plasma EFV concentrations were estimated by HPLC, and certain pharmacokinetic variables were calculated. Results: Plasma EFV concentrations were higher in females than males at all the time points, the differences being significant at 1 (p<0.001) and 2 (p=0.05) hours. Females had significantly higher peak concentration (Cmax) of EFV than males (p=0.05) (3.11 & 1.90 μg/ml). The inter-individual variability in Cmax and AUC0-48 were 42 and 45% respectively. Conclusions: This study provides basic information on the pharmacokinetics of EFV in Indian subjects. Females had higher peak levels of EFV than males. Inter-subject variability was high. Further studies are necessary to describe the pharmacokinetic profile of EFV under steady state conditions in Indian patients on antiretroviral treatment.

Item Type:	Article
Uncontrolled Keywords:	Efavirenz, HIV infection, pharmacokinetics, Indian subjects
Subjects:	Tuberculosis > Laboratory Research > Biochemical
Divisions:	Basic Science Research > Biochemistry
Depositing User:	Dr. Rathinasabapati R
Date Deposited:	06 Jan 2014 10:08
Last Modified:	09 Mar 2016 04:48
URI:	http://eprints.nirt.res.in/id/eprint/799

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