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| |  Oral Cytovene May Prevent Deadly Infection In Kidney Transplant Recipients CHICAGO, May 13, 1997 -- Data presented this weekend at the annual meeting of the American Society of Transplant Physicians confirm that oral ganciclovir (Cytovene(R) capsules) may prevent potentially life-threatening cytomegalovirus (CMV) infection and disease in renal transplant recipients. The study showed that the overall incidence of CMV disease in patients, during 12 weeks of prophylaxis with Cytovene capsules, was reduced by 100 percent versus the deferred treatment group. In addition, the benefits persist after discontinuation of prophylaxis. Cytomegalovirus disease, which occurs in 20-60 percent of renal transplant recipients, affects people with compromised immune systems and can be deadly. It most frequently develops during the first three months after transplantation when immunosuppression is greatest and contributes significantly to post-transplant morbidity and mortality. "It concerns me to see kidney transplant recipients needlessly developing CMV when I know it can be prevented," said Daniel Brennan, MD, director of Transplant Nephrology at Washington University School of Medicine, study presenter and principal investigator. "Transplant physicians now have data that demonstrates oral ganciclovir is a good option for preventing CMV disease in kidney as well as liver transplant recipients." 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. "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. Not only can we can catch the disease, but we can prevent the infection from activating with oral ganciclovir prophylaxis," said Brennan. CMV in transplant recipients can cause CMV syndrome (fever, malaise), invasive tissue disease (including hepatitis and pneumonia), and increased immunosuppression. Study Methodology and Results This study comprised 42 kidney transplant recipients who were either CMV seropositive themselves and/or received a kidney from a CMV seropositive donor. The purpose of the study was to compare the incidence of CMV in patients on prophylaxis versus deferred treatment. (This study is not a comparison study between oral ganciclovir and acyclovir.) The patients were randomized to receive oral ganciclovir (1000 mg tid x 12 weeks) or deferred therapy with intensive monitoring (including acyclovir 200 mg bid x 12 weeks for prophylaxis of herpes infection). All patients were followed for six months. CMV viremia was measured using PCR at weeks 1 through 15, and at months 5 and 6. Patients who developed symptomatic CMV viremia were switched to I.V. ganciclovir (5mg/kg every 12 hours) for three weeks. Sixty one percent of patients who developed CMV disease in the deferred treatment groups (14/23) did so during the first twelve weeks post-transplantation. All patients in the oral ganciclovir arm who developed CMV disease (4/19) did so after prophylaxis was completed. At six months, the incidence of CMV disease was 21 percent in the oral Cytovene group compared to 61 percent in the deferred treatment group. For those patients that developed CMV, the time to development of disease was delayed with oral ganciclovir prophylaxis -- 133 days (+/-17) compared with 31 days (+/-7) with deferred treatment. About Cytovene Cytovene inhibits the ability of CMV to replicate, thereby slowing the progression of the disease. Cytovene, capsules and I.V., are indicated for the prevention of CMV disease in solid organ 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(R) capsules includes granulocytopenia, anemia and thrombocytopenia. In animal studies, ganciclovir was carcinogenic, teratogenic and caused spermatogenesis. About Hoffmann-La Roche
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