BACKGROUND: Most studies of adherence to highly active antiretroviral therapy in children have been retrospective or cross-sectional. Factors relating to the caregiver, the child and the medication are all considered to be important for good adherence. METHODS: Adherence with taking prescribed medication was assessed by questionnaires completed at 4, 12, 24 and 48 weeks by caregivers of previously untreated HIV-infected children participating in the PENTA 5 trial, which was designed to evaluate different dual nucleoside reverse transcriptase inhibitor therapy combinations with and without the protease inhibitor nelfinavir. The effects of several factors on adherence and the effect of adherence on virologic suppression were assessed by multivariate logistic regression. RESULTS: Caregivers returned 266 questionnaires including at least 1 for 108 (84%) children in the trial. Nelfinavir was reported to be the most difficult drug to take (38% of questionnaires), but the difficulty decreased over time, P = 0.02. Comments on difficulties in taking and remembering drugs related to fear of disclosure and to unpleasant characteristics of the drugs. Full adherence was reported in 74% of questionnaires, did not change over time and was reported more frequently in children older than 10 years and those with symptomatic HIV disease. More children reporting full adherence achieved HIV RNA <400 copies/ml (e.g. at 48 weeks 79% vs. 50% reporting some nonadherence; overall P = 0.01). CONCLUSION: Good adherence with taking prescribed medication was associated with virologic response. Social factors were important in explaining nonadherence.
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