Date: Janurary 15, 1996
For Immediate Release
Contact: NEI (301) 496-5248 or JAS@B31.nei.nih.gov

TWO-DRUG TREATMENT IS EFFECTIVE AGAINST RECURRENT EYE INFECTION IN AIDS PATIENTS

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