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      Long-term efficacy and safety of atazanavir/ritonavir treatment in a real-life cohort of treatment-experienced HIV patients

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          Abstract

          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. 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. 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) 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.

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          Author and article information

          Conference
          J Int AIDS Soc
          Journal of the International AIDS Society
          BioMed Central
          1758-2652
          2010
          8 November 2010
          : 13
          : Suppl 4
          : P31
          Affiliations
          [1 ]Competence Network for HIV/AIDS, Bochum, Germany
          [2 ]Karolinska Institutet, Karolinska University Hospital, Department of Infectious Diseases, Stockholm, Sweden
          [3 ]Nice University Hospital, Infectious Diseases Department, Nice, France
          [4 ]Bristol-Myers Squibb Company, Wallingford, CT, USA
          [5 ]Hays Pharma, Paris, Franc
          [6 ]Clinic for Dermatology, Venerology, and Allergolog, Competence Network for HIV/AIDS, Bochum, Germany
          [7 ]Clinical Trial Centre, Cologne, Germany
          [8 ]Clinical Centre Driesener Straße, Berlin, Germany
          [9 ]MVZ Karlsplatz, Munich, Germany
          [10 ]Ifi-Institut, Hamburg, Germany;
          [11 ]Bristol-Myers Squibb Company, Paris, France
          Article
          1758-2652-13-S4-P31
          10.1186/1758-2652-13-S4-P31
          3113033
          4e06bd0e-f2a8-495e-babe-3d723fc94300
          Copyright ©2010 Jansen et al; licensee 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.

          Tenth International Congress on Drug Therapy in HIV Infection
          Glasgow, UK
          7-11 November 2010
          History
          Categories
          Poster Presentation

          Infectious disease & Microbiology
          Infectious disease & Microbiology

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