San Francisco Chronicle (SF); Tuesday, October 22, 1991
Charles Petit, Chronicle Science Writer

In nationwide tests, ganciclovir, the only other drug that has been effective against the infection, worked equally well at saving eyesight but showed no impact on survival time.

In announcing the unexpected result in Washington, officials at the National Eye Institute said they sent urgent "clinical alert" messages last week to 40,000 American doctors telling them that for most AIDS patients, foscarnet should be the first drug tried against eye infections caused by the cytomegalovirus, or CMV.

4 MONTHS' DIFFERENCE

The average survival time of AIDS patients after diagnosis of CMV retinitis is about eight months, but those being treated with foscarnet typically lived about 12 months, according to Dr. Douglas Jabs, a John Hopkins School of Medicine eye specialist and chairman of the study at 12 medical centers.

The reason for the extended life span is unclear and does not seem to be connected to the control of CMV retinitis.

Some experts suggest that it may not result directly from the drug but rather from the ability of patients to tolerate both foscarnet and other drugs such as AZT, which attack the human immunodeficiency virus, or HIV, which causes AIDS.

The test involved about 240 AIDS patients and compared the performance of foscarnet (manufactured under the trade name Foscavir by Astra Pharmaceutical Products, Inc., of Massachusetts) with ganciclovir (manufactured under the name Cytovene by Syntex Corp. of Palo Alto).

STUDY TERMINATED

Federal officials said yesterday that they abruptly terminated the study October 7 as early results started to come in, hoping to prolong the lives of patients who might take foscarnet.

"The study showed absolutely no difference at all in controlling CMV retinitis . . . but there is a significant difference in survival," said Dr. Mark Jacobson, chairman of a national panel on CMV complications of AIDS and an infectious disease specialist at San Francisco General Hospital and the University of California at San Francisco.

The extension of life span with foscarnet "is a very important observation," Jacobson said, "and one that is very hard to explain."

Dr. James O'Donnell, an ophthalmologist and associate dean at UCSF who conducted a portion of the study in San Francisco, said that since the decision to stop the trial, patients using ganciclovir have been offered the option to switch to foscarnet. "We have been really busy notifying all the patients," he said.

PATIENTS' DILEMMA

About one AIDS patient in five develops CMV retinitis, in which the virus attacks the retina at the back of the eye.

In the early years of the AIDS epidemic, doctors had virtually no weapon against the viral eye infection. Ganciclovir, approved in June 1989, proved able to slow and sometimes stop CMV retinitis, but it could seldom be given in conjunction with high doses of AZT, because both drugs suppress the immune system. For some AIDS patients, this meant a choice between keeping their sight or living longer.

Patients using foscarnet can be treated simultaneously with AZT. However, doctors running the comparison test said it was not possible to determine that this is the reason why patients taking foscarnet lived longer than those taking ganciclovir.

Officials and AIDS experts said some patients are still better off with ganciclovir, particularly those with kidney problems, which are aggravated by foscarnet.

Both drugs are expensive: Foscarnet costs about $58 per day, and ganciclovir about $29 per day. Both are bothersome to take because they must be given at least once a day through intravenous injection.

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