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ICAAC In Brief: Roche's oral Cytovene

Executive Summary

Roche's oral Cytovene: Phase III trial data in 304 patients show that 14 weeks of oral Cytovene (ganciclovir) reduces incidence of cytomegalovirus disease in liver transplant patients from 19.5% in placebo to 4.8%, according to presentation at Interscience Conference on Antimicrobial Agents and Chemotherapy in New Orleans Sept. 16. Oral ganciclovir was also associated with a reduction in tissue invasive CMV disease, from 4.8% in placebo-treated patients to .7%. Roche filed a supplemental NDA June 14 based on six-month data from the one-year trial...
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