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| |  DG DISPATCH - CROI: Oral Valganciclovir As Effective As IV Ganciclovir For CMV Retinitis By Edward Susman Special to DG News
SAN FRANCISCO, CA -- February 8, 2000 -- Researchers say they have shown for the first time that an oral drug can control cytomegalovirus retinitis in patients with HIV infection.
The new drug, valganciclovir, the oral prodrug of intravenous ganciclovir, is as effective as the intravenous drug in controlling the sight-threatening opportunistic infection, said Dr. Daniel Martin, associate professor of vitreo-retinal surgery and diseases at the Robert Woodruff Health Science Center, Emory University, Atlanta. At the 7th Conference on Retroviruses and Opportunistic Infections, in San Francisco, Dr. Martin said, "Valganciclovir provides and effective and convenient alternative to intravenous ganciclovir for the treatment of CMV retinitis." Dr. Martin said that 77 percent of patients treated with the intravenous compound achieved a satisfactory response, clearing the CMV infection in their eyes, compared with 72 percent of patients taking the oral compound. He said those percentages were no statistically significantly different. "Since no orally administered compound had ever been shown to render CMV retinitis inactive," Dr. Martin said, "the logical first step and, really, the highest hurdle for this compound was to determine if valganciclovir could be used for induction therapy." He said that the drug failed to prevent progression of CMV retinitis in 10 percent of patients-virtually the same as for patients taking the intravenous ganciclovir. He said that the median time for progression of retinitis for patients originally assigned to intravenous ganciclovir was 126 days versus 180 days for patients assigned to valganciclovir. Dr. Martin noted, "Patients were on randomly assigned treatment for four weeks and then, after four weeks, all patients were on open-label oral valganciclovir. One would assume that if induction had been less successful in the valganciclovir group that this would manifest as a shorter time to progression of retinitis." He said the results are almost superimposable, "if anything, there is a trend in the favor of valganciclovir." Dr. Martin's presentation was well-received. "I guess we are all believers that this is going to work," said Dr. Judith Aberg, professor of medicine at the Washington University School of Medicine, in St. Louis, and moderator of the session at the conference. "A 900-mg dose of valganciclovir-that is two 450 mg tablets-appears to provide a ganciclovir exposure similar to 5 mg of intravenous ganciclovir," Dr. Martin said. The study, an international collaboration with 41 centers participating, scattered across the United Kingdom, Germany, Spain, France, Italy, New Zealand, Australia, Mexico, the United States and Canada, enrolled 160 patients with newly diagnosed CMV retinitis. Although 80 patients were originally assigned to each treatment group, eight patients from each group were eventually eliminated for various reasons-the main one being a lack of retinal photographic evidence that there was CMV retinitis at entry. During the randomized portion of the trial there was no difference in adverse events, Martin said.
Related Link: ganciclovir.
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