Long-term efficacy and safety of atazanavir/ritonavir treatment in a real-life cohort of treatment-experienced HIV patients
verfasst von:
K Jansen, A Sönnerborg, P Pugliese, S Biguenet, JL Eychenne, NH Brockmeyer, C Michalik, S Dupke, H Jaeger, A Plettenberg, D Butcher, MJ Jiménez-Expósito, HIV KompNet
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.
Methods
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.
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Summary of results
Data for 1294 ARV-experienced patients (prior ARV exposure: mean, 5.70 years) were analyzed. Patients were predominantly male (74%); median age 43 years (min, max: 18, 85); 75% had prior exposure to PIs (mean: 3.5 years). At baseline (BL), 56% of patients had HIV-1 RNA < 500 c/mL and 37% had < 50 c/mL. The estimated proportion of patients remaining on ATV during the follow-up period was 52% (median duration of treatment: 3.7 years); 54% for patients with BL HIV-1 RNA < 500 c/mL and 50% for those with BL HIV-1 RNA > 500 c/mL. The estimated probability of discontinuation was 21% during the first year and decreased at each subsequent 1-year treatment interval. Time to virologic failure is presented in Figure 1.
Fig 1
Time to virologic failure (two consecutive HIV-1 RNA ≥ 50 c/mL or one HIV-1 RNA ≥ 50 c/mL followed by discontinuation)
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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)•
Conclusions
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.
This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Long-term efficacy and safety of atazanavir/ritonavir treatment in a real-life cohort of treatment-experienced HIV patients
verfasst von
K Jansen A Sönnerborg P Pugliese S Biguenet JL Eychenne NH Brockmeyer C Michalik S Dupke H Jaeger A Plettenberg D Butcher MJ Jiménez-Expósito HIV KompNet
