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Date: Janurary 15, 1996 For Immediate Release Contact: NEI (301) 496-5248 or JAS@B31.nei.nih.gov
A combination of two antiviral drugs is more effective than either drug alone for controlling recurrences of a blinding eye infection common in people with AIDS, according to new clinical trial results from a federally-sponsored study.
In January's Archives of Ophthalmology, researchers report that daily intravenous administration of both foscarnet and ganciclovir is a more effective way to treat repeat episodes of cytomegalovirus (CMV) retinitis than treatment with either drug alone.
"This finding advances the treatment of a chronic, destructive eye infection that causes blindness if it is not controlled," said Carl Kupfer, M.D., director of the National Eye
Institute (NEI). The NEI, part of the National Institutes of Health (NIH), sponsored the CMV Retinitis Retreatment Trial. Additional NIH support was provided by the National Center for Research Resources and the National Institute of Allergy and Infectious Diseases.
For patients who received both drugs, the CMV retinitis was controlled for about four months on average. Among those treated with either foscarnet or ganciclovir alone, the eye infection recurred in one to two months on average. The combination treatment was associated with the least reduction in the field of vision, but visual acuity was preserved equally well in all drug regimens tested.
However, researchers cautioned that the two-drug therapy takes longer, because each drug has to be administered separately. In addition, the side effects associated with two-drug therapy may be more difficult to tolerate than those with one drug alone. Also, because two drugs are required, the treatment is more expensive than it would be if only one drug was used.
CMV retinitis is an infection of the retina, the light-sensing tissue that lines the back of the eye. The virus that causes it can infect the eye, colon, lung, and other organs of people with AIDS or other diseases that result in weakened immune systems. According to some studies, up to 40 percent of people with AIDS develop CMV retinitis, the most common cause of vision loss from the disease.
Currently, CMV retinitis is typically treated with twice-daily intravenous infusion of either foscarnet or ganciclovir for two weeks, followed by daily infusions which are usually continued for the rest of the patient's life. There also is an oral form of ganciclovir that is available for long-term suppressive therapy. While the two drugs work equally well for a first episode of CMV retinitis, nearly all patients suffer a relapse of the retinitis at some point. With each relapse, more retinal cells are destroyed and more vision is lost.
"Combination therapy was much better than treatment with either foscarnet or ganciclovir alone in controlling the retinitis progression," said study chairman Douglas A. Jabs, M.D., of The Johns Hopkins University and Hospital. "However, combination therapy was more inconvenient, required two infusions, and will be more expensive. But for those patients who have suffered a relapse of their retinitis and can tolerate combination therapy, its improved control of the retinitis offers distinct advantages."
The CMV Retinitis Retreatment Trial involved 279 patients who had already had the eye infection and had been treated with either foscarnet or ganciclovir, but experienced a relapse and needed further treatment. They were randomly assigned to foscarnet alone, ganciclovir alone, or both drugs.
The trial was part of an ongoing clinical research project called Studies of the Ocular Complications of AIDS (SOCA).
(A list of participating clinical centers follows)
1-11-96
Participating Clinical Centers CMV Retinitis Retreatment Trial
California Gary Holland, M.D. Jules Stein Eye Institute University of California, Los Angeles School of Medicine 100 Stein Plaza Los Angeles, California 90095-7003 (310) 825-9508 William Freeman, M.D. Shiley Eye Center, 0946 University of California, San Diego 9415 Campus Drive La Jolla, California 92093-0946 (619) 534-3513 James O'Donnell, M.D. Beckman Vision Center University of California, San Francisco Box 0730, Room K-301 10 Kirkham Street San Francisco, California 94143 (415) 476-1921 Florida Janet Davis, M.D. Bascom Palmer Eye Institute University of Miami 900 N.W. 17th Street Miami, Florida 33136 (305) 326-6377 Illinois David Weinberg, M.D. Department of Ophthalmology Northwestern University Medical School 645 North Michigan, Suite 440 Chicago, Illinois 60611 (312) 908-8152 Louisiana Bruce Barron, M.D. LSU Eye Center Louisiana State University Medical Center 2020 Gravier Street, Suite B New Orleans, Louisiana 70112 (504) 568-6700, ext. 307 Maryland James P. Dunn, M.D. Wilmer Ophthalmological Institute The Johns Hopkins University School of Medicine 600 N. Wolfe St., Maumenee 119 Baltimore, Maryland 21287-9217 (410) 955-2966 New York Murk-Hein Heinemann, M.D. Department of Ophthalmology Memorial Sloan-Kettering Cancer Center 525 East 68th St. New York, New York 10021 (212) 746-2483 Alan Friedman, M.D. Department of Ophthalmology Mount Sinai School of Medicine Box 1183 One Gustave L. Levy Place New York, New York 10029 (212) 241-6241 Dorothy Friedberg, M.D. Department of Ophthalmology New York University Medical Center 310 Lexington Avenue New York, New York 10016 (212) 687-0265 North Carolina Charles van der Horst, M.D. University of North Carolina at Chapel Hill CB 7030, 547 Burnett-Womack Building Chapel Hill, North Carolina 27599 (919) 966-2536 Texas Richard Lewis, M.D. Cullen Eye Institute Baylor College of Medicine 6501 Fannin, NC-200 Houston, Texas 77030 (713) 798-6100 RESOURCE CENTERS Study Chairman Douglas Jabs, M.D. Wilmer Ophthalmological Institute The Johns Hopkins University and Hospital 550 North Broadway, Suite 700 Baltimore, Maryland 21205 (410) 955-1966 Coordinating Center Curtis Meinert, Ph.D. Department of Epidemiology School of Hygiene and Public Health The Johns Hopkins University 615 North Wolfe Street, Room 5010 Baltimore, Maryland 21205 (410) 955-8198 Fundus Photograph Reading Center Matthew Davis, M.D. Department of Ophthalmology and Visual Sciences University of Wisconsin 610 Walnut St. WARF Building, Room 420 Madison, Wisconsin 53705-2336 (608) 263-5749