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FDA recommends AIDS-related CMV treatment
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GAITHERSBURG, Md. — The Food and Drug Administration’s Anti-Viral Drugs Advisory Committee (AVAC) in February unanimously recommended the use of valganciclovir HCl (Roche) for maintenance therapy and issued a 12-1 recommendation for induction therapy for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS.
AVAC’s vote to recommend approval was made after the company presented data comparing treatment of CMV retinitis with valganciclovir, which is taken orally, to treatment with Cytovene IV (ganciclovir).
Valganciclovir is the pro-drug of Cytovene, an anti-CMV medication, also made by Roche. As a pro-drug of ganciclovir, valganciclovir is rapidly converted to ganciclovir in the body.
Roche scientists presented the AVAC with data from a randomized, controlled study in patients with AIDS and newly diagnosed CMV retinitis that compared the efficacy of valganciclovir and Cytovene IV in CMV induction therapy.
Analysis of the primary CMV progression endpoint revealed that after 4 weeks of therapy, the proportion of patients with progression as measured by retinal photography was the same in both treatment groups.
Safety data was presented for 370 patients who received valganciclovir for an average of 320 days. In general, valganciclovir’s adverse event profile was similar to ganciclovir and included low blood cell counts (granulocytopenia, anemia, thrombocytopenia), diarrhea, nausea, vomiting, fever and fatigue.