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Hepsera and Renal Toxicity
Apr 10, 2005

Hepsera in high doses has been associated with renal toxicity. Under the current label, Gilead does not provide any guidance as to the frequency of renal monitoring. How often do patients must be monitored for renal function (in patients with no history of kidney problems).

Response from Dr. McGovern

The doses which were associated with significant renal toxicity when Adefovir (Hepsera) was used for the treatment of HIV were 60 to 120 mg daily. At the doses of Hepsera recommended for hepatitis B (10 mg), renal (kidney)toxicity does not appear to be an issue. However, I still monitor creatinine,(one measure of kidney function) particularly in patients who may have other occult underlying renal problems, ie diabetics, patients with underlying HIV, etc. I also get a baseline urinalysis to be certain that there is no occult proteinuria which may give me a clue to an underlying kidney problem even if the creatinine is normal. The frequency of monitoring is unknown. I tend to get monthly laboratories anyway so I usually check a serum creatinine in anyone with risk factors for kidney disease. I think quarterly monitoring is acceptable and more cost-effective, particularly in those without risk factors. I also want to emphasize that this is only just my personal opinion.

Dr. McGovern



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