Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Immunology | Ophthalmology | 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 June 1996
Treatment Area: CMV retinitis
Vistide was approved for the treatment for CMV retinitis in
subjects with AIDS.
Vistide is known to have a much longer duration of activity than
other antiviral treatments and therefore requires less frequent
dosing. Vistide was administered in clinical studies only once
every other week after a two-dose induction and does not require a
chronic catheter for administration.
This approval was based upon data from two pivotal studies
demonstrating that Vistide delays the time to progression of CMV
retinitis. These studies were conducted in subjects with CMV
retinitis and AIDS. One study enrolled newly diagnosed subjects who
had not received prior CMV treatment and the other study enrolled
subjects with relapsing disease that had progressed despite
extensive treatments with other intravenous therapies for CMV
A third clinical study of Vistide is being conducted by an
independent NIH-sponsored research group, the Studies of Ocular
Complications of AIDS (SOCA). In March 1996, enrollment of new
subjects in this study was stopped based upon an interim analysis
of safety and efficacy data suggesting Vistide delayed the time to
progression of CMV retinitis.
The major toxicity of Vistide is renal impairment. The potential
for nephrotoxicity can be minimized with the administration of
probenecid tablets and hydration on the day of each Vistide
infusion. In addition, laboratory measurements of a subject's
urine protein and serum creatinine, a blood marker of kidney
function, are monitored before each dose of Vistide. Proper use of
these tests can guide physicians to adjust the Vistide dosage and
minimize the potential for toxicity.
CMV retinitis is caused by a viral infection that, if untreated
progresses rapidly, affects a subject's vision over time, and
may ultimately lead to blindness. It is estimated that up to 40% of
subjects with AIDS may develop retinitis and that 95% of subjects
with AIDS are infected with CMV. As people with AIDS live longer,
the incidence of CMV retinitis has been increasing.
When CMV invades the retina, lesions form on the light-sensitive
layer of cells at the back of the eye that transmit images to the
brain. As these CMV lesions progress, the subject’s vision
deteriorates over time.