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Bernard A. Schwetz, DVM,PhD

JAMA. 2001;285:2705.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA has approved valganciclovir (Valcyte, Syntex LLC, Roche Global Development, Palo Alto, Calif) for induction and maintenance therapy of cytomegalovirus (CMV) retinitis in patients with AIDS. Valganciclovir is an orally administered prodrug of ganciclovir that provides improved bioavailability.

The efficacy of induction therapy was shown in the results of an open-label, controlled multicenter study of intravenously administered ganciclovir in 160 patients with AIDS who had newly diagnosed CMV retinitis. After 4 weeks, approximately 10% of the patients had evidence of CMV retinitis progression, determined by a treatment-masked review of retinal photographs. This new efficacy end point demonstrated that valganciclovir is clinically equivalent to intravenous ganciclovir.

Recommendations for use of valganciclovir as maintenance therapy for CMV retinitis were based on the pharmacokinetic profile of ganciclovir after valganciclovir administration, supported by additional safety data. The adverse event profile of valganciclovir was comparable to that of the approved . . . [Full Text of this Article]

Acting Principal Deputy Commissioner
Food and Drug Administration

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