Plasma Drug Level Validates Self-Reported Adherence but Predicts Limited Specificity for Nonadherence to Antiretroviral Therapy

Abstract EN

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.