Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Immunology | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved December 1996
Treatment Area: CMV
Oral Cytovene has been approved for the prevention of
cytomegalovirus (CMV), a potentially life-threatening infection, in
recipients of solid organ transplants.
The FDA approval is based on data, which demonstrate that oral
Cytovene given as prophylaxis reduced the overall incidence of CMV
disease in liver transplant recipients by 78%.
Oral Cytovene received marketing clearance based on the results
of GAN 040, a multinational, randomized, double-blind study
compromising 304 orthotopic liver transplant (OLT) recipients
randomized (1:1) to receive oral ganciclovir (1000 mg three times
daily) or matching placebo, for up to 14 weeks following
The six-month incidence of CMV disease was 18.9% in the placebo
group compared to 4.8% in the oral Cytovene group. Of the oral
Cytovene patients who developed CMV disease, only one (0.7%)
developed invasive tissue disease, the most severe type of CMV
disease, versus 8.4% 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 CMV sero-positive organ. The six-month incidence of CMV disease
in this group was 44% in placebo patients versus 14.8% in oral
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% in the placebo group versus 4.6% in the
The six-month incidence of herpes simplex was reduced from 23.5%
in the placebo arm to 3.5% in those receiving oral ganciclovir
The most common adverse events in this study were infection,
fever, and headache. These events occurred with similar frequency
in the ganciclovir-treated and placebo groups.
More than 20,000 people received solid organ transplants (heart,
lung, pancreas, kidney, liver, etc.) in the United States in 1995.
CMV disease occurs in approximately 15-30% of all solid organ
transplant recipients, primarily in the first three months
post-transplantation when immunosuppression is most intense--and is
a frequent cause of morbidity.
CMV, a member of the herpes family of viruses, infects
approximately 50% 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 in transplant recipients can cause a debilitating CMV
syndrome (fever, malaise), and life-threatening invasive tissue
disease (including hepatitis and pneumonia), and increased
immunosuppression with resulting secondary infections.