Drug Slows Onset of AIDS : Symptoms Delayed Among Test Patients

An experimental AIDS drug has shown early promise in delaying the onset of the deadly disease in some people who are infected with the AIDS virus but have not yet developed severe symptoms, a California pharmaceutical company announced Friday.

Because AIDS is invariably fatal once it develops, the test data is potentially significant for the estimated 1 million to 2 million Americans infected with the AIDS virus and millions of other AIDS virus carriers throughout the world.

But officials of ICN Pharmaceuticals of Costa Mesa--along with a researcher who participated in ICN-sponsored trials--cautioned that ribavirin has not been shown to cure or prevent the disease.

“We don’t have enough evidence to say ribavirin prevents AIDS. The drug may delay the onset of AIDS for at least seven months,” said Dr. Karl Johnson, ICN’S vice president for medical affairs. “But it will not surprise me if some of the (test) patients (who are well today) eventually come down with AIDS.”

“We realize the implications if our study is finally supported,” Johnson said, adding that the supply of the medicine could be rapidly increased within the next year if necessary.

The 24-week study involved 163 homosexual men, divided into three groups. All were infected with the AIDS virus, as shown by a blood test. All of them felt well but had enlarged lymph nodes and severe immune system abnormalities, Johnson said.

In one group, 52 patients were given a 800-milligram dose of ribavirin; none developed AIDS, according to ICN officials.

In a second group, 55 patients received a smaller dose of ribavirin; six developed AIDS.

In the final group, 56 patients were given placebo pills; 10 developed AIDS.

Result Gets Mixed Reactions

Almost all the patients are now taking the high dose of the drug, ICN officials said.

At a press conference, researchers who participated in the ribavirin trials had mixed reactions to the ICN announcement.

“I believe this represents some hope,” said Dr. Peter Heseltine of County-USC Medical Center in Los Angeles.

“I would like to see more data before I would be enthusiastic,” added Dr. Lawrence Kaplan of San Francisco General Hospital, who is participating in a ribavirin test with patients afflicted with AIDS-Related Complex, or ARC, which is a less severe form of the disease.

Kaplan’s caution was shared by Jeffrey Levi, executive director of the National Gay and Lesbian Task Force in Washington. “Too many drugs have been hyped by the drug companies as a big thing but have not panned out,” he said. “It does no good to give people false hopes.”

In addition to about 50 journalists who covered Friday’s press conference were many Wall Street securities analysts, who sat listening attentively to the questions and answers.

ICN also arranged for the press conference, held at the posh Marriott Hotel in downtown Washington, to be aired by audio hookup at its headquarters in Costa Mesa. About a dozen reporters and television news crews--from as far away as San Francisco--attended that session.

Ribavirin, an anti-viral medicine, was discovered by an ICN chemist in 1970. It has been tested as a treatment for influenza, hemorrhagic fever and other infections, in addition to the AIDS virus.

The drug, in pill form, is now available in about 25 countries, including Portugal, Brazil and Mexico, usually under the brand name Virazole, and some Americans AIDS patients have gone to Mexico to obtain it. In the United States, a ribavirin nasal spray is available by prescription to treat young children with severe lung infections caused by respiratory syncytial virus.

FDA Reviewing Drug

The partial results of the AIDS ribavirin study were announced at a press conference a few days after ICN provided data to the U.S. Food and Drug Administration. Next week, ICN is expected to ask the FDA for permission to expand usage of the drug, perhaps to include other patients in similar situations.

FDA officials, who have been expediting expected approval of another promising AIDS drug, azidothymidine, or AZT, confirmed that they are reviewing the ribavirin data but have no immediate plans to make the drug more widely available.

Tests have shown that AZT may be effective in prolonging the lives of AIDS patients who have developed a serious lung infection called pneumocystis . Some of these patients, however, have developed serious side effects, such as severe anemia, which have required them to stop taking the drug.

Most patients taking ribavirin in the ICN study had no side effects, although some developed mild anemia, Johnson said. Ribavirin is known to sometimes cause severe anemia when taken in larger doses than those used in the ICN study.

The study was conducted at County-USC Medical Center in Los Angeles, Cornell University Medical Center in New York City, M.D. Anderson Hospital in Houston and the University of Miami.

The AIDS virus attacks the body’s immune system, leaving the victim vulnerable to a variety of infections and tumors. It is transmitted by sexual contact, by contaminated blood and from an infected mother to her newborn. As of Monday, 29,137 Americans had developed AIDS and 16,481 had died, according to the federal Centers for Disease Control.