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Date of Report: 01/09/2003
Author: Susa Coffey, MD, Associate Medical Editor, AETC NRC
Source: National Resource Center
Description: News brief
The Food and Drug Administration has approved an extended-release formulation of the nucleoside analog stavudine (D4T), called Zerit XR. This new formulation has been shown to maintain therapeutic plasma concentrations of stavudine over a 24-hour dosing interval. Zerit XR is intended for once-daily administration. Its recommended dose is 100 mg once daily for patients who weigh 60 kg or greater, 75 mg once daily for patients who weight less than 60 kg. It is intended for use in combination with other antiretroviral medications.
Several clinical studies have compared extended-release stavudine to the intermediate-release formulation. A large randomized controlled trial of extended-release versus intermediate-release stavudine, used in combination with lamivudine and efavirenz in treatment-naive patients, has shown equivalent rates of viral suppression and CD4 increase at 48 weeks, as well as comparable tolerability and safety. 1
The full label will soon be posted on the FDA website at http://www.fda.gov/cder/approval/index.htm.
1. RB Pollard, JG Baril, F Raffi, M Whelden, et al. Stavudine extended/prolonged release (XR/PRC) vs stavudine immediate release (IR) in combination with lamivudine and efavirenz: 48 week efficacy and safety. Abstract LbPeB9014. 14th International AIDS Conference . July 7-12, 2002; Barcelona.
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