Therapeutic drug monitoring of nevirapine in saliva in Uganda using high performance liquid chromatography and a low cost thin-layer chromatography technique

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dc.contributor.authorLamorde, Mohammed
dc.contributor.authorFillekes, Quirine
dc.contributor.authorSigaloff, Kim
dc.contributor.authorKityo, Cissy
dc.contributor.authorBuzibye, Allan
dc.contributor.authorKayiwa, Joshua
dc.contributor.authorMerry, Concepta
dc.contributor.authorNakatudde-Katumba, Lillian
dc.contributor.authorBurger, David
dc.contributor.authorRinke de Wit, Tobias F.
dc.date.accessioned2023-03-03T18:11:30Z
dc.date.available2023-03-03T18:11:30Z
dc.date.issued2014
dc.description.abstractIn resource limited settings access to laboratory monitoring of HIV treatment is limited and therapeutic drug monitoring is generally unavailable. This study aimed to evaluate nevirapine concentrations in saliva using low-cost thin-layer chromatography (TLC) and nevirapine concentrations in plasma and saliva using high performance liquid chromatography (HPLC) methods; and to correlate nevirapine plasma concentrations to HIV treatment outcomes in Ugandan patients. Methods: Paired plasma and stimulated saliva samples were obtained from Ugandan, HIV-infected adults on nevirapine-based ART. Nevirapine concentrations were measured using a validated HPLC method and a novel TLC method. Plasma nevirapine concentrations <3.0 mg/L using HPLC were considered subtherapeutic. Negative/positive predictive values of different thresholds for subtherapeutic nevirapine concentrations in saliva were determined. Virologic testing and, if applicable, HIV drug resistance testing was performed. Results: Median (interquartile range, IQR) age of 297 patients was 39.1 (32.8-45.2) years. Three hundred saliva and 287 plasma samples were available for analysis. Attempts failed to determine nevirapine saliva concentrations by TLC. Using HPLC, median (IQR) nevirapine concentrations in saliva and plasma were 3.40 (2.59-4.47) mg/L and 6.17 (4.79-7.96) mg/L, respectively. The mean (coefficient of variation,%) nevirapine saliva/plasma ratio was 0.58 (62%). A cut-off value of 1.60 mg/L nevirapine in saliva was associated with a negative/positive predictive value of 0.99/ 0.72 and a sensitivity/specificity of 87%/98% for predicting subtherapeutic nevirapine plasma concentrations, respectively. Only 5% (15/287) of patients had subtherapeutic nevirapine plasma concentrations, of which 3 patients had viral load results > 400 copies/mL. Patients with nevirapine concentrations in plasma <3.0 mg/L had an Odds Ratio of 3.29 (95% CI: 1.00 – 10.74) for virological failure (viral load >400 copies/mL). Conclusions: The low-cost TLC technique for monitoring nevirapine in saliva was unsuccessful but monitoring nevirapine saliva and plasma concentrations using HPLC was shown to be feasible in the research/specialist context in Uganda. Further optimization and validation is required for the low-cost TLC technique.en_US
dc.identifier.citationLamorde, M., Fillekes, Q., Sigaloff, K., Kityo, C., Buzibye, A., Kayiwa, J., ... & de Wit, T. F. R. (2014). Therapeutic drug monitoring of nevirapine in saliva in Uganda using high performance liquid chromatography and a low cost thin-layer chromatography technique. BMC Infectious Diseases, 14(1), 1-6. doi:10.1186/1471-2334-14-473en_US
dc.identifier.other10.1186/1471-2334-14-473
dc.identifier.urihttps://nru.uncst.go.ug/handle/123456789/8073
dc.language.isoenen_US
dc.publisherBMC Infectious Diseasesen_US
dc.subjectTherapeutic drug monitoringen_US
dc.subjectNevirapineen_US
dc.subjectSalivaen_US
dc.subjectLiquid chromatographyen_US
dc.subjectThin-layer chromatography techniqueen_US
dc.titleTherapeutic drug monitoring of nevirapine in saliva in Uganda using high performance liquid chromatography and a low cost thin-layer chromatography techniqueen_US
dc.typeArticleen_US
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