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FDA Approves Zerit Once Daily, Extended Release Formulation

January 10, 2003

On December 31, 2002 the Food and Drug Administration approved a new, extended release formulation of Zerit (stavudine, d4T) called Zerit XR. This extended-release formulation has been shown to maintain viral suppression for 24 hours after once-daily dosing. The recommended dose of Zerit XR is 100 mg once daily for individuals weighing at least 60 kg and 75 mg once daily for individuals weighing less than 60 kg. As with all antiretrovirals, it must be used in combination with at least two other anti-HIV drugs.

The following information was noted by the FDA in its approval announcement: In a clinical study conducted in 783 treatment-naive, HIV-infected individuals Zerit XR was comparable to the previously approved twice daily formulation of Zerit. In this randomized, controlled study, participants were randomized to either the extended release or standard formulation, in combination with Epivir and Sustiva. The proportion of people with HIV-RNA (viral load levels) below 400 copies at 48 weeks was 79 percent and 76 percent for the extended release and immediate release-containing regimens, respectively. For viral load under 50, the response rates were 55 percent and 57 percent for the new and old formulations, respectively. The tolerability and safety profile of the new once daily, extended release formulation is comparable to that of the previously approved twice-daily formulation.

This adds one more drug to the list of once-a-day FDA-approved antiretrovirals. The other drugs include Videx, Videx EC, Sustiva, Epivir, and Viread. It is expected that the new once-a-day protease, Atazanavir, will be approved sometime in the next few months. For more information on once-a-day HIV treatments, see the article in the Fall 2002 STEP Perspective, "Once-Daily Antiretroviral Options."


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