| HIGHLIGHTS FROM ICAAC
�97 Combination
CYMEVENE� Oral Ganciclovir and VITRASERTTM Ocular Implant (GAN2304 Study)
New data show that combining CYMEVENE� oral ganciclovir
capsules with Vitrasert, a ganciclovir-containing ocular implant, delays the onset of
cytomegalovirus (CMV) retinitis in the eye and reduces the incidence of CMV disease in
other organs in the body. Study participants receiving the CYMEVENE + Vitrasert
combination took longer to progress to CMV retinitis in the implanted eye compared to
subjects treated with the Vitrasert implant alone.
Combination Reduces Incidence of Another
Opportunistic Infection
In addition to slowing the onset of CMV retinitis and CMV
disease, an analysis of study participants also suggested that subjects receiving the
CYMEVENE + Vitrasert combination had a lower incidence of Kaposi�s sarcoma (KS). Only
2.7 percent of participants in the combination CYMEVENE + Vitrasert arm developed KS, as
opposed to 11 percent of participants in the Vitrasert-only arm. Subjects receiving
CYMEVENE + Vitrasert also required fewer hospitalizations and spent fewer days in the
hospital.
Background on the GAN2304 Study
The GAN2304 is a randomized, controlled study of 377
participants with CMV retinitis diagnosed in one eye only. When enrolled in the study,
each subject was either newly diagnosed or stable following treatment with IV CYMEVENE .
Participants were randomly assigned to one of three trial arms: Vitrasert and oral
CYMEVENE capsules (1500 mg tid); Vitrasert and oral placebo; or CYMEVENE-IV standard
induction (5 mg/kg every 12 hours for 14 to 21 days), then maintenance regimen (5 mg/kg
once daily, 7 days/week).
Over one year, participants were given regular eye
examinations, physical exams, and standardized fundus photographs of the retina were
taken. The primary outcome measures for study 2304 were the occurrence of new CMV disease
(retinitis in the unaffected eye or CMV disease in another organ) and survival. Secondary
measures included progression of retinitis, the safety and tolerability of each regimen,
the occurrence of other AIDS-associated conditions and quality of life.
The median survival times in the combination, IV, and
implant-only arms were 568 days, 426 days, and 388 days, respectively. Data indicate that
progression of CMV retinitis in the infected eye was significantly delayed in the CYMEVENE
+ Vitrasert combination group compared to the Vitrasert-only arm. After six months of
treatment, 22.4 percent of participants in the combination group experienced a recurrence
of CMV disease, compared to 37.8 percent of subjects receiving therapy with the implant
alone and 17.9 percent in the IV ganciclovir group. Adverse events were similar among all
treatment arms except for neutropenia, which occurred more often in both ganciclovir
groups, and sepsis which was more common in the IV group.
A subset analysis of participants who received therapy with
protease inhibitors for the first time during the trial found a lower incidence of new CMV
disease compared to participants who had not received protease inhibitor therapy.
Table of Contents
|
