(1) to determine the evolution of renal function
in highly treatment-experienced patients with normal renal function at baseline
receiving tenofovir as part of a combination antiretroviral regimen; and
(2)
to identify prognostic factors for changes in renal function, including tenofovir
concentrations.
The investigators conducted a prospective 48-week open-label
trial that evaluated the safety of tenofovir used with ritonavir-boosted
atazanavir (Reyataz) and optimized nucleoside
reverse transcriptase inhibitors (NRTIs) in patients with documented prior
treatment failure.
The study included 53 participants with a median CD4
cell count of 206 cells/mm3 and a median HIV RNA level of 5 log10 copies/mL. At
baseline, all patients had normal serum creatinine levels and creatinine clearance
(markers of renal dysfunction), which were stable within the 2 months preceding
study inclusion.
Two patients discontinued tenofovir due to severe renal
impairment and 2 never started tenofovir, leaving 49 subjects without clinical
nephrotoxicity to be analyzed. Statistical analysis was performed on an intent-to-treat
basis.
Results The median creatinine level increased significantly
from baseline to week 48 (+0.04 mg/dL; P = 0.008).
The median creatinine clearance decreased significantly
(-7.8 mL/min; P = 0.005).
Trough tenofovir concentration was not associated with
changes in creatinine clearance (P = 0.79).
No risk factors, including tenofovir plasma trough levels,
were significantly associated with changes in creatinine clearance at week 24.
Conclusion
According to the study authors, "This study
confirms that tenofovir-related severe nephrotoxicity is an uncommon event."
"In
patients without clinical nephrotoxicity, the use of tenofovir during a 1-year
period was associated with a slight but significant alteration of renal function,
which was not associated with increased trough concentration," they added.
INSERM SC10, Villejuif, France.
12/07/07
Reference L
Gérard L, C Chazallon, AM Taburet, and others. Renal function in antiretroviral-experienced
patients treated with tenofovir disoproxil fumarate associated with atazanavir/ritonavir.
Antiviral Therapy 12(1): 31-39. 2007. 
|
| |