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dc.contributor.authorByakika-Kibwika, Pauline
dc.contributor.authorLamorde, Mohammed
dc.contributor.authorKalemeera, Francis
dc.contributor.authorMauro, Sciandra
dc.contributor.authorDi Perr, Giovanni
dc.contributor.authorRyan, Mairin
dc.contributor.authorMayanja-Kizza, Harriet
dc.contributor.authorKhoo, Saye
dc.contributor.authorBack, David
dc.contributor.authorBoffito, Marta
dc.contributor.authorMerry, Concepta
dc.date.accessioned2013-02-14T14:38:17Z
dc.date.available2013-02-14T14:38:17Z
dc.date.issued2008-07-19
dc.identifier.citationByakika-Kibwika, P., Lamorde, M., Kalemeera, F., Mauro, S., Di Perr, G., Ryan, M., Mayanja-Kizza, H., Khoo, S., Back, D., Boffito, M., Merry, C. (2008). Steady-state pharmacokinetic comparison of generic and branded formulations of stavudine, lamivudine and nevirapine in HIV-infected Ugandan adults. Journal of Antimicrobial Chemotherapy, 62.en_US
dc.identifier.issn0305-7453
dc.identifier.urihttp://hdl.handle.net/10570/1062
dc.descriptionJournal of Antimicrobial Chemotherapyen_US
dc.description.abstractBackground: We aimed to compare the steady-state pharmacokinetic parameters and tolerability of Triomune 40w (stavudine 40 mg, lamivudine 150 mg and nevirapine 200 mg) and branded formulations of these drugs in HIV-infected Ugandans. Methods: This includes a randomized, open-label, cross-over study of HIV-infected patients stable on therapy for 1 month. Patients were randomized to generic or branded formulation. Plasma pharmacokinetics were assessed after 1 month. The following day, alternate formulation was administered, and 1 month later, drug pharmacokinetics were re-assessed. Plasma pharmacokinetics were determined using HPLC–UV detection. Similarity between steady-state pharmacokinetic parameters was assessed using the US Food and Drug Administration standards for bioequivalency testing. Tolerability was assessed using questionnaires. Results: Sixteen (10 females) patients completed the study. Median (IQR) age, weight and CD4 count were 37 (33.7–40) years, 65 (63.4–66) kg and 292 (220.7–344.5) cells/mm3, respectively. All patients received co-trimoxazole. The geometric mean ratio (90% CI) for stavudine, lamivudine and nevirapine was 0.92 (0.78–1.08), 1.11 (0.95–1.30) and 0.84 (0.64–1.11), respectively, for Cmax, and 0.83 (0.70–0.97), 1.06 (0.94–1.20) and 0.88 (0.71–1.10), respectively, for AUC. Stavudine plasma concentrations were significantly lower for the generic formulation. Pharmacokinetic parameter inter individual variability ranged from 29% to 99%. There were no differences in tolerability for the two formulations. Conclusions: Pharmacokinetic profiles of generic and branded drugs were similar. Differences particularly with regard to stavudine were demonstrated. Surveillance of the quality of generic antiretroviral drugs in the target populations is needed. Capacity building for pharmacokinetic research in resourcelimited settings is a priority.en_US
dc.description.sponsorshipDepartment of Foreign Affairs, Ireland and the Infectious Diseases Network for Treatment and Research in Africa (INTERACT).en_US
dc.language.isoenen_US
dc.publisherOxford University Pressen_US
dc.subjectAntiretroviral therapyen_US
dc.subjectPKen_US
dc.subjectUgandaen_US
dc.subjectStavudineen_US
dc.subjectUgandaen_US
dc.subjectLamivudineen_US
dc.subjectAntiretroviral Drugsen_US
dc.titleSteady-state pharmacokinetic comparison of generic and branded formulations of stavudine, lamivudine and nevirapine in HIV-infected Ugandan adultsen_US
dc.typeJournal article, peer revieweden_US


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