title: Plasma drug level validates self-reported adherence but predicts limited specificity for nonadherence to antiretroviral therapy.
abstract: Introduction. Adherence to antiretroviral therapy (ART) in low-income countries is mainly assessed by self-reported adherence (S-RA) without drug level determination. Nonadherence is an important factor in the emergence of resistance to ART, presenting a need for drug level determination. Objective. We set out to establish the relationship between plasma stavudine levels and S-RA and validate S-RA against the actual plasma drug concentrations. Methods. A cross-sectional investigation involving 234 patients in Uganda. Stavudine plasma levels were determined using high-performance liquid chromatography. We compared categories of plasma levels of stavudine with S-RA using multivariable logistic regression models. Results. Overall, 194/234 patients had S-RA ≥ 95% (good adherence) and 166/234 had stavudine plasma concentrations ≥ 36 nmol/L (therapeuticconcentration). Patients with good S-RA were eight times more likely to have stavudine levels within therapeutic concentration (Adjusted Odds Ratio: 7.7, 95% Confidence Interval: 3.5-7.0). However, of the 194 patients with good S-RA, 21.7% had below therapeutic concentrations. S-RA had high sensitivity for adherence (91.6%), but limited specificity for intrinsic poor adherence (38.2%). Conclusions. S-RA is a good tool for assessing adherence, but has low specificity in detecting nonadherence, which has implications for emergence of resistance.
authors.affiliation: Department of Pharmacology and Therapeutics, School of Biomedical Sciences, College of Health Sciences, Makerere University, P.O. Box 7072, Kampala, Uganda.
authors.forename: Robert
authors.initials: R
authors.lastname: Balikuddembe
authors.forename: Joshua
authors.initials: J
authors.lastname: Kayiwa
authors.forename: David
authors.initials: D
authors.lastname: Musoke
authors.forename: Muhammad
authors.initials: M
authors.lastname: Ntale
authors.forename: Steven
authors.initials: S
authors.lastname: Baveewo
authors.forename: Paul
authors.initials: P
authors.lastname: Waako
authors.forename: Celestino
authors.initials: C
authors.lastname: Obua