Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Wednesday October 1 4:57 PM EDT
"This study is significant because it demonstrates the best way to treat patients with CMV retinitis is to combine intense local therapy (Vitrasert) with systemic treatment (CYTOVENE capsules)," said Dr. Daniel Martin, principal investigator, Emory University School of Medicine.
Additional benefit from systemic therapy
Researchers observed that there was an overall lower incidence of Kaposis' sarcoma (KS) (p=0.008) in patients in the ganciclovir groups*. Approximately 11 percent of patients randomized to the implant arm developed KS, while the incidence was 2.7 percent in the combination arm and 1.5 percent in the I.V. arm.
Patients on CYTOVENE capsules in addition to the implant also required fewer hospitalizations (p=0.019), spent fewer days in the hospital (p=0.043) and had a reduced incidence of new AIDS-associated conditions (p=0.018).
"Patients who develop opportunistic infections are at significant risk for developing other complications," Martin added. "It is interesting to note the added benefit that ganciclovir provided these patients."
*CYTOVENE is not approved for the treatment or prevention of Kaposis' sarcoma.
About GAN2304
GAN2304 is a randomized, controlled study comprising 377 trial participants with unilateral (one eye only) CMV retinitis that, upon study entry, was either newly diagnosed or stable following treatment with I.V. CYTOVENE. Participants were randomly assigned to one of three trial arms: Vitrasert (ganciclovir implant) and CYTOVENE capsules (1500 mg tid**): Vitrasert and oral placebo; or CYTOVENE-I.V. at standard induction (5 mg/kg every 12 hours for 14 to 21 days), then maintenance regimens (5 mg/kg once daily, seven days/week).
Trial participants were followed regularly, for one year, with eye examinations, physical exams and standardized fundus photographs. The primary outcome measure for study 2304 was the occurrence of new CMV disease (retinitis in the unaffected eye or 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, I.V. and implant arms were, 568,426 and 388, respectively (p=NS). Both implant groups had a longer time to progression than those treated with I.V., CYTOVENE(R) alone. Data indicate that progression of retinitis in the implanted eye was significantly delayed in the combination group compared to the implant alone (p=0.03). After six months of treatment, 22.4 percent of patients in the combination group experienced new CMV disease, compared to 37.8 percent of patients receiving therapy with the implant alone (p=0.02) and 17.9 in the I.V. CYTOVENE group (p=O.001). 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 I.V. group.
In a subset analysis of patients who received therapy with protease inhibitors during the trial, there was a low incidence of new CMV disease.
About CMV
CMV disease is one of the most common opportunistic infections to strike people with AIDS and can affect organs throughout the body ("systemic" disease) causing life-threatening infections. CMV retinitis is the most frequent manifestation of CMV disease, affecting an estimated 15 to 40 percent of patients with AIDS. It usually begins as a white infiltrate within the retina, and can progress rapidly to cause destruction of retinal tissue. Retinal damage can lead to detachment of the retina and permanent loss of vision.
** The recommended dose of CYTOVENE capsules for maintenance therapy is 1000 mg/tid
About CYTOVENE and Vitrasert
CYTOVENE inhibits CMV replication, thereby slowing the progression of CMV disease. CYTOVENE-I.V. is indicated for the treatment of CMV retinitis in immunocompromised patients, including PWAs, and for the prevention of CMV disease in transplant recipients at risk for CMV disease. CYTOVENE capsules are indicated only for the prevention of CMV disease in solid organ transplant recipients and in individuals with advanced HIV infection at risk for developing CMV disease. CYTOVENE capsules are also available as an alternative to the intravenous formulation for maintenance treatment of CMV retinitis in immunocompromised patients, including PWAs, in whom retinitis is stable following appropriate induction therapy and for whom the risk of more rapid progression is balanced by the benefit associated with avoiding daily I.V. infusions. The clinical toxicity of CYTOVENE-I.V. and capsules includes granulocytopenia, amenia and thrombocytopenia. In animal studies, ganciclovir was carcinogenic, teratogenic and caused spermatogenesis.
The Vitrasert Implant was cleared for marketing by the U.S. Food and Drug Administration (FDA) in 1996 for treatment of CMV retinitis in PWAs. Potential complications of the Vitrasert implant procedure are those affiliated with ocular surgery. The Vitrasert Implant is the result of a collaboration between Chiron Vision and Hoffmann-La Roche. The implant utilizes technology developed by Paul Ashton, Ph.D. and Thomas Smith, M.D. in association with the University of Kentucky, and was licensed from Control Delivery Systems, Inc.
About Roche Laboratories Inc.
Roche Laboratories Inc. is the marketing and sales subsidiary of Hoffmann-La Roche Inc., a leading research-intense pharmaceutical company. Roche Laboratories markets more than 35 medications in major therapeutic areas including AIDS, oncology, transplantation, infectious diseases, cardiovascular diseases and dermatology.
SOURCE Hoffman-La Roche Inc.
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