PR Newswire - October 31, 1995

"The possibility of going blind is one of the most serious concerns of people with AIDS. Now there is something to help prevent this disabling infection," said Stephen Spector, professor and virologist at the University of California, San Diego. "The problem with CMV retinitis has been that many patients do not get diagnosed until the disease has already compromised their sight. Preventive treatment means that we can help patients avoid the debilitating symptoms of this disease."

Study Results

According to the Roche Bioscience (formerly Syntex) multicenter study 1654, CMV prophylaxis with oral Cytovene is associated with a 49 percent risk reduction in the development of CMV disease compared with placebo. The study was conducted 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.

A planned interim analysis completed in July 1994 demonstrated the significant efficacy of oral Cytovene over placebo, and an independent Data and Safety Monitoring Board recommended discontinuation of the placebo arm of the study.

In addition, viral isolates obtained to date from study participants during an average of 10 months of prevention treatment rarely showed resistance to oral Cytovene (estimated at one percent).

At the dosages used in the prevention study (3 grams daily), the incidence of anemia, neutropenia (reduced white blood count), and elevated serum creatinine were higher in the group receiving oral Cytovene compared to the group receiving placebo. Gastrointestinal disturbances were the most commonly reported adverse events, but occurred with similar frequency in both study groups.

Cytovene for Prevention and Treatment

Cytovene capsules are now indicated for the prevention of CMV disease in individuals with advanced HIV infection at risk for developing CMV disease. CMV disease includes retinitis as well as CMV-related gastrointestinal and neurological disorders. Cytovene capsules are also indicated as an alternative to Cytovene-I.V. for maintenance treatment of CMV retinitis in immunocompromised patients, including people with AIDS. Before capsules are considered, retinitis must be stabilized with I.V. induction therapy and the risk of more rapid disease progression must be balanced by the benefit associated with avoiding daily I.V. infusions.

About Cytomegalovirus and CMV Retinitis

Cytomegalovirus, a member of the herpes family of viruses, infects more than 50 percent of the U.S. adult population. In individuals with healthy immune systems, the virus remains in the body in a dormant state. However, among individuals with compromised immune systems, such as AIDS and organ transplant patients, the virus can become active and cause disease.

CMV retinitis, the most common ophthalmologic complication of AIDS, causes an inflammation of the retina which can be sight-threatening. CMV retinitis may not cause visual symptoms and therefore early diagnosis requires routine screening by an ophthalmologist. When symptoms of CMV retinitis do occur they include distorted vision, blind spots and "floaters" -- small dark spots in the eye.

CMV Retinitis Screening Program

Hoffmann-La Roche recently launched a CMV Retinitis Screening Program to help raise awareness of CMV retinitis among people with AIDS. The program consists of simple tools including a video, brochure and Amsler grid -- a diagnostic tool that people with AIDS can use to check for symptoms of retinitis in-between regular physician visits. The program is available to AIDS service organizations (ASOs) and to individual patients. Physician speakers are available to ASOs through June 1996 to speak to organizations about CMV retinitis and provide information about how to access the screening program. To request a physician-led seminar, ASO staff can contact 1-800-293-7428. Individual patients can request a package containing the screening video, brochure and Amsler grid by calling 1-800-624-CHECK.

Hoffmann-La Roche

Hoffmann-La Roche Inc., marketer of Cytovene-I.V. and Cytovene capsules, is a research-based health care company and member of the Roche Group, which is headquartered in Basel, Switzerland. Roche Bioscience (formerly Syntex), also a member of the Roche Group, developed both the I.V. and oral formulations of Cytovene. Roche is a leading international health care company dedicated to the research, development and delivery of diagnostic tests, treatments and services for people infected with life-threatening diseases.

NOTE TO EDITORS: Full prescribing information is available upon request./

CONTACT: Joy Schmitt for Hoffmann-La Roche, 201-562-2202/ 09:15 EST

Copyright (c) 1995/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
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