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| |  Oral Cytovene Can Prevent CMV Disease in Liver Transplant Recipients DALLAS, May 29, 1996 -- Data presented for the first time today suggest that oral ganciclovir (Cytovene(R) capsules) can help prevent potentially life-threatening cytomegalovirus (CMV) disease in liver transplant recipients. Data from study GAN 040, "Efficacy and Safety of Oral Ganciclovir in the Prevention of CMV Disease in Liver Transplant Recipients," presented at the annual meeting of the American Society of Transplant Surgeons, suggest that Cytovene capsules given as prophylaxis reduced the overall incidence of CMV disease by 79 percent versus placebo. More than 3,900 people received liver transplants in the U.S. in 1995. CMV disease occurs in approximately 29 percent of liver transplant recipients -- primarily in the first three months post-transplantation when immunosuppression is most intense -- and is a frequent cause of morbidity. Intravenous ganciclovir (Cytovene-I.V.) is presently the only medication generally indicated as preventive therapy for CMV disease in solid organ transplant recipients. Based on the results of GAN 040, Roche plans to submit a supplemental New Drug Application (NDA) for oral ganciclovir to the U.S. FDA. "The transplant community has been waiting a long time for this news," said Edward Gane, MD, Middlemore Hospital, New Zealand, formerly at Kings College Hospital, London, study presenter and principal investigator. "Although we have successfully been using daily I.V. infusions of Cytovene to manage CMV disease in transplant recipients, many physicians and patients would welcome an oral therapeutic as a convenient way to prevent disease." Study Methodology and Results GAN 040 is a multinational, randomized, double-blind study comprising 304 orthotopic liver transplant (OLT) recipients randomized (1:1) to receive oral ganciclovir (1000 mg three times daily) or matching placebo. The six-month incidence of CMV disease was 19.5 percent in the placebo group compared to 4.8 percent in the oral Cytovene group. Of the oral Cytovene patients who developed CMV disease, only one (0.7 percent) developed tissue invasive disease, the most severe type of CMV disease, versus 9.8 percent of placebo patients. Oral Cytovene helped prevent CMV disease even in those recipients at highest risk for CMV disease -- those who were sero-negative for CMV at the time of their transplant and received a sero-positive organ. The six-month incidence of CMV disease in this group was 44 percent in placebo patients versus 14.8 percent of oral ganciclovir patients. Patients who received the most intense immunosuppression also benefited from prophylaxis with oral Cytovene. Of those patients receiving anti-lymphocyte antibodies either for prevention of graft rejection or for treatment of refractory rejection, the incidence of CMV disease was 33 percent in the placebo group versus 4.6 percent in the ganciclovir group. The most common adverse events in this study were immune system disorder, infection, fever and headache. These events occurred with similar frequency in the ganciclovir-treated and placebo groups. At the time of analysis, there were 14 deaths in the placebo group and six deaths in the ganciclovir group. Transplant Recipients and CMV Cytomegalovirus, a member of the herpes family of viruses, infects approximately 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 organ transplant recipients and people with AIDS, the virus can cause life-threatening and/or sight-threatening illness. "Our experience in both transplant and AIDS patients has shown that it is much better to prevent CMV disease than to try and treat it," said Gane. "CMV can infect organs throughout the body, and because its symptoms often mimic those of other infections that strike when the immune system is suppressed, CMV disease can be very difficult to diagnose and control." CMV in transplant recipients can cause CMV syndrome (fever, malaise), invasive tissue disease (including hepatitis and pneumonia), and increased immunosuppression. About Cytovene Cytovene inhibits the ability of CMV to replicate, thereby slowing the progression of the disease. Cytovene-I.V. is indicated for the prevention of CMV disease in transplant recipients at risk for CMV disease. It is also indicated for the treatment of CMV retinitis in immunocompromised patients, including people with AIDS. Oral Cytovene is indicated for the prevention of CMV disease in HIV-infected individuals who are at risk of developing CMV disease, and as an alternative to the I.V. formulation for maintenance treatment of CMV retinitis in people with impaired immune systems whose CMV retinitis is stable following appropriate I.V. therapy and only in those for whom the risk of more rapid disease progression is balanced by the benefit associated with avoiding daily I.V. infusions. The clinical toxicity of Cytovene-I.V. and Cytovene capsules includes granulocytopenia, anemia and thrombocytopenia. In animal studies, ganciclovir was carcinogenic, teratogenic and caused spermatogenesis. About Hoffmann-La Roche Roche Laboratories Inc., of Nutley, N.J., is the pharmaceutical sales and marketing subsidiary of Hoffmann-La Roche Inc., a research- based health care company that is 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, treatments and services for people with life- threatening diseases.
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