Long-term efficacy and safety of atazanavir/ritonavir treatment in a real-life cohort of treatment-experienced HIV patients
© Jansen et al; licensee BioMed Central Ltd. 2010
Published: 8 November 2010
Purpose of the study
Atazanavir (ATV)-based regimens have demonstrated efficacy and safety in both ARV-naïve and -experienced patients. However, few reports have assessed effectiveness beyond 2 years. The aim of this study was to describe the long-term outcomes of ATV/r containing regimens in ARV-experienced patients in a clinical setting.
Non-comparative, retrospective, observational study which collected data from 3 European databases (France-DatAids, Germany-KompNet, Sweden-InfCare). Clinical data for ARV-experienced adult patients who started an ATV/r-based regimen between October, 2004 and March, 2007 were extracted every 6-months (maximum follow-up 5 years). Primary endpoint was the proportion of patients remaining on ATV treatment by baseline HIV-1 RNA (< 500 or ≥ 500 c/mL). Secondary endpoints included virologic response and reason for discontinuation. The duration of treatment and time to virologic failure were analyzed using the Kaplan-Meier method.
Summary of results
The most frequent reasons for discontinuation were "unknown" (32%), adverse events (25%), patient withdrew consent (13%) and lack of efficacy (11%). Hyperbilirubinemia was reported as reason for discontinuation in 12 patients. No unexpected changes in metabolic parameters were observed and renal AEs were reported rarely (1.9/100 patient-years)•
In real life setting, ATV/r-based regimen demonstrated sustained virological efficacy in an ARV-experienced population including patients with previous virological failure. After long-term treatment a high proportion of patients remained on an ATV regimen and no unexpected AEs were observed.
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