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News From the Food and Drug Administration
June 6, 2001

Oral Therapy for CMV Retinitis

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JAMA. 2001;285(21):2705. doi:10.1001/jama.285.21.2705-JFD10005-2-1

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.

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