Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
PR Newswire - 01 Feb 1996
"Put together, the data presented this week provide further evidence for the safety and efficacy of Cytovene as prophylaxis for CMV-disease," said W. Lawrence Drew, M.D., University of California, San Francisco, and one of the principal investigators of 1654. "These data should help HIV-infected individuals and their healthcare providers make decisions about CMV prophylactic treatment."
Previously-presented efficacy data from study 1654, a randomized, placebo-controlled study of the efficacy and safety of oral ganciclovir for prevention of CMV disease, demonstrate that CMV prophylaxis with Cytovene is associated with a 49 percent risk reduction in the development of CMV disease compared to placebo.
CMV disease is one of the most common opportunistic infections in the late stages of AIDS. The most frequent manifestation of CMV disease, CMV retinitis, affects up to 40 percent of people with AIDS, and is the most common ophthalmological complication of AIDS. CMV can also cause gastrointestinal and neurological disorders.
Low Viral Resistance
The 1654 resistance data presented by Drew today demonstrate that the prevalence of ganciclovir resistance is low -- estimated at less than one percent after prophylaxis for a mean duration of 8.3 months (251 days). This estimate is based on in-vitro testing of 40 CMV-culture isolates from urine, and confirms preliminary data presented at ICAAC in September.
"These results should greatly reduce one of the major concerns regarding oral ganciclovir prophylaxis for CMV disease," said Drew.
Further Support for Efficacy of Prophylaxis
Also at the Retroviruses Conference, Richard Wolitz, M.D., Kaiser Permanente, San Francisco, reported that among those subjects who developed CMV retinitis (59 of 486 with ganciclovir prophylaxis, 52 of 239 with placebo), there was a greater frequency of sight-threatening (known as "Zone 1") retinitis in placebo patients (20/52, 38 percent) at the time of diagnosis versus ganciclovir-treated patients (9/57, 16 percent). The frequency of retinitis occurring in both eyes at the time of diagnosis was similar in both groups (17 percent in ganciclovir group, versus 25 percent in placebo group).
"Loss of vision is, understandably, a major concern for people with AIDS," said Wolitz. "This finding is important because it suggests that, even for those patients who developed CMV retinitis, prophylaxis with Cytovene was associated with a lower incidence of initially sight- threatening disease."
About Study 1654 and Cytovene
Syntex, now a member of the Roche Group, conducted study 1654 in 725 persons infected with HIV (CD4 cells less than or equal to 100) -- 486 subjects were randomized to oral Cytovene and 239 to a placebo control. In October 1995, the U.S. Food and Drug Administration cleared oral Cytovene for the prevention of CMV disease in individuals with advanced HIV infection at risk for developing CMV disease based on the final efficacy results from study 1654.
Cytovene works by inhibiting the ability of CMV to replicate, thereby slowing the progression of the disease. Cytovene capsules are also indicated as an alternative to Cytovene-I.V.(R) for maintenance treatment of CMV retinitis in immunocompromised patients, including people with AIDS. The clinical toxicity of Cytovene and Cytovene-I.V. includes granulocytopenia, anemia and thrombocytopenia. Before capsules are prescribed, retinitis must be stabilized with I.V. induction therapy and the benefits associated with avoiding daily I.V. infusions must outweigh the risk of more rapid disease progression.
About Roche
Hoffmann-La Roche Inc. is a research-based Health Care Company and a member of The Roche Group, with headquarters in Basel, Switzerland. Roche is a leading health care company dedicated to the research, development and delivery of diagnostic tests, treatment and services for people with life-threatening diseases.
NOTE TO EDITORS: For full prescribing information, please contact Joy Schmitt at 201-562-2202.
CONTACT: Joy Schmitt of Hoffmann-La Roche Inc., 201-562-2202/ 09:04 EST
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