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Renal function in antiretroviral-experienced patients treated with tenofovir disoproxil fumarate associated with atazanavir/ritonavir.
- Source :
-
Antiviral therapy [Antivir Ther] 2007; Vol. 12 (1), pp. 31-9. - Publication Year :
- 2007
-
Abstract
- Objective: To determine the evolution of renal function in highly treatment-experienced patients with normal renal function at baseline receiving tenofovir disoproxil fumarate (TDF) as part of a fixed combined antiretroviral regimen and to identify prognostic factors of change in renal function, including tenofovir concentrations.<br />Methods: A prospective 48-week open-label trial was carried out, evaluating the safety of TDF, associated with atazanavir/ritonavir, and optimized nucleoside reverse transcriptase inhibitors, in patients with documented failure in previous treatments. Statistical analysis was performed on an intent-to-treat basis.<br />Results: Fifty-three patients were included, with a median CD4+ T-cell count of 206 x 10(6)/l and a median HIV RNA level of 5 log10 copies/ml. All patients had normal serum creatinine levels and creatinine clearances (CL(Cr)) at baseline, which were stable within the 2 months preceding inclusion. Two patients discontinued TDF as a result of severe renal impairment. Two patients never started TDF. A total of 49 patients without clinical nephrotoxicity were analysed. The median creatinine level increased significantly from baseline to week 48 (+0.04 mg/dl [+5.8%]; P = 0.008), and the median CL(Cr) decreased significantly (-7.8 ml/min [-7.6%]; P = 0.005). Trough tenofovir concentration was not associated with change in CL(Cr), (P = 0.79). No risk factors, including tenofovir plasma trough levels, were significantly associated with change in CL(Cr) at week 24.<br />Conclusions: This study confirms that TDF-related severe nephrotoxicity is an uncommon event. In patients without clinical nephrotoxicity, the use of TDF during a 1-year period was associated with a slight but significant alteration of renal function, which was not associated with increased trough concentration.
- Subjects :
- Adenine adverse effects
Adenine pharmacokinetics
Adult
Antiretroviral Therapy, Highly Active
Atazanavir Sulfate
CD4 Lymphocyte Count
Creatinine blood
Female
France
HIV Infections immunology
Humans
Kidney Diseases blood
Kidney Diseases physiopathology
Male
Middle Aged
Models, Biological
Organophosphonates pharmacokinetics
Prognosis
Prospective Studies
Reverse Transcriptase Inhibitors pharmacokinetics
Tenofovir
Treatment Outcome
Adenine analogs & derivatives
HIV Infections drug therapy
HIV Protease Inhibitors therapeutic use
Kidney Diseases chemically induced
Oligopeptides therapeutic use
Organophosphonates adverse effects
Pyridines therapeutic use
Reverse Transcriptase Inhibitors adverse effects
Ritonavir therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1359-6535
- Volume :
- 12
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Antiviral therapy
- Publication Type :
- Academic Journal
- Accession number :
- 17503745