Objectives: To identify variables predictive of nonadherence to highly active antiretroviral therapy (HAART) and to assess whether self-reported symptoms or medication side effects are related to adherence.
Design: Cross-sectional multicenter study Adherence Italian Cohort Naive Antiretrovirals [AdICONA] within the Italian Cohort Naive Antiretrovirals (ICONA).
Methods: Participants receiving HAART completed a 16-item self-administered questionnaire to assess nonadherence in the last 3 days as well as the type and intensity of 24 common HIV- and HAART-related symptoms experienced during the last 4 weeks.
Results: From May 1999 to March 2000, 358 persons were enrolled: 22% reported nonadherence and were less likely to have HIV RNA <500 copies/ml (odds ratio = 0.51; 95% confidence interval: 0.31-0.85). Frequency of moderate/severe symptoms or medication side effects in nonadherent participants ranged from 3.6% to 30%. On univariate analysis, nausea, anxiety, confusion, vision problems, anorexia, insomnia, taste perversion, and abnormal fat distribution were significantly associated with nonadherence. Nonadherent persons had a higher mean overall symptom score (12.3 +/- 9.2 versus 8.1 +/- 6.6; p <.001) and mean medication side effect score (2.9 +/- 2.7 versus 1.9 +/- 1.9; p <.001) when compared with adherent participants. In the multivariate analysis, nausea ( p =.003); anxiety ( p =.006); younger age ( p =.007); unemployment ( p <.001); not recalling name, color, and timing of drugs ( p =.009); running out of pills between visits ( p =.002); and being too busy ( p =.03) were independently associated with nonadherence in the last 3 days.
Conclusions: In addition to patient characteristics, medication-related variables, and reasons for nonadherence, patient-reported symptoms and medication side effects were significantly associated with adherence to HAART.