Effectiveness and tolerability of a once-daily amprenavir/ritonavir-containing highly active antiretroviral therapy regimen in antiretroviral-naïve patients at risk for nonadherence: 48-week results after...
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Date
2004-09-16
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Abstract
OBJECTIVES To determine the safety and effectiveness of a once daily highly active antiretroviral therapy HAART regimen in patients at risk for poor adherence using directly observed therapy DOT for 24 weeks followed by weekly phone contact for another 24 weeks METHODS A prospective open label pilot study was carried out Antiretroviral na ve patients with advanced HIV disease were treated with once daily amprenavir 1200 mg ritonavir 200 mg didanosine 400 mg and lamivudine 300 mg After 24 weeks DOT was substituted by weekly phone contact Measurements of viral load and CD4 cell count and safety laboratory measurements were taken regularly for 48 weeks RESULTS Twenty two patients were enrolled in the study of whom 19 completed at least 4 weeks of treatment Seventeen patients completed 24 weeks and 13 completed 48 weeks None discontinued treatment as a result of adverse events The median baseline HIV viral load was 5 29 log 10 HIV 1 RNA copies mL and the median CD4 cell count was 20 cells microL At weeks 24 and 48 74 of the patients had viral loads Under400 copies mL At 48 weeks the median decrease in viral load from baseline was 3 06 log 10 copies mL and the median increase in CD4 cell count was 118 cells microL The median trough plasma amprenavir concentrations at weeks 1 and 24 were 1 87 and 1 42 microg mL respectively CONCLUSIONS This study suggests that DOT followed by weekly patient contact results in good treatment outcome in this challenging population The median trough plasma amprenavir concentrations were above the effective concentration of drug that resulted in 90 inhibition of viral load in vivo EC 90 for wild type HIV