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Nevirapine clearance from plasma in African adults stopping therapy: a pharmacokinetic substudy.
- Source :
-
AIDS (London, England) [AIDS] 2007 Mar 30; Vol. 21 (6), pp. 733-7. - Publication Year :
- 2007
-
Abstract
- Objective: To measure nevirapine elimination in African adults undertaking a structured treatment interruption (STI) in the DART trial.<br />Design: Cohort (16 women, 5 men; median weight 61 kg) within a randomized trial of management strategies.<br />Methods: Plasma nevirapine was measured by validated high performance liquid chromatography at 0,1,2,3 and 4 weeks after stopping the drug in a subset of patients undertaking an STI. All patients continued lamivudine plus zidovudine/stavudine for a further 7 days.<br />Results: Two patients with no or low plasma nevirapine concentration at baseline were excluded. Geometric mean plasma concentration when nevirapine was stopped in the remaining 19 patients was 6421 ng/ml (range, 3724-9473). Nevirapine was detected in 15/18 (83%) patients at 1 week, and 5/19 (26%) patients at 2 weeks but was not found any samples collected after 2 weeks. Only one patient had > 100 ng/ml (limit of quantification) at 2 weeks (415 ng/ml, female). The median times to reach thresholds of 200, 100 and 20 ng/ml (limit of detection) were estimated to be 7.6 [interquartile range (IQR), 7.0-10.1], 9.3 (IQR, 8.7-13.0) and 13.2 (IQR, 12.3-18.4) days, respectively, with 3/19 (16%) and 14/19 (74%) estimated to have reached < 20 ng/ml by 7 and 14 days, respectively.<br />Conclusion: Although elimination of nevirapine was faster than previously published after a single dose, the data suggest that an additional staggered period of 7-10 days with dual nucleotide reverse transcriptase inhibitor cover is necessary for African patients discontinuing nevirapine.
- Subjects :
- Adult
Cohort Studies
Drug Therapy, Combination
Female
HIV Infections drug therapy
HIV Infections epidemiology
Humans
Lamivudine therapeutic use
Male
Middle Aged
Nevirapine blood
Nevirapine therapeutic use
Reverse Transcriptase Inhibitors blood
Reverse Transcriptase Inhibitors therapeutic use
Stavudine therapeutic use
Uganda epidemiology
Zidovudine therapeutic use
Zimbabwe epidemiology
HIV Infections blood
Nevirapine pharmacokinetics
Reverse Transcriptase Inhibitors pharmacokinetics
Subjects
Details
- Language :
- English
- ISSN :
- 0269-9370
- Volume :
- 21
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- AIDS (London, England)
- Publication Type :
- Academic Journal
- Accession number :
- 17413694
- Full Text :
- https://doi.org/10.1097/QAD.0b013e3280121801