THE NEW YORK TIMES

Monday, January 27, 1997

AIDS MEETING ENDS WITH HOPE FOR EXPERIMENTAL DRUG

By Lawrence K. Altman

Washington, Jan.26 - A major AIDS meeting ended here today with hope

that some of the experimental drugs reported on will ultimately ease

the burden of patients who must adhere to difficult regimes when they take the drugs that are now available. Another hope is that if some of

the experimental drugs are licensed, they will provide new options for the many people who do not benefit from existing combinations. Speakers at the meeting, which drew more than 2,300 AIDS experts and other scientists, said they had been astonished by the favorable turn of events since last year's AIDS conference, when combination drug therapies were first shown to be able to suppress H.I.V., the virus that caused AIDS, below the limits of detection. The combination therapies use older drugs like AZT and a new class of drug, protease inihibitors. The wider use of various combinations, including some that do not include protease inihibitors, are now promising to transform AIDS into a chronic disease that is manageable. Nevertheless, speaker after speaker said drugs would not end the worldwide AIDS epidemic, in part because poor countries could not afford their cost. The only hope for denting the global epidemic is a vaccine against H.I.V., but no breakthroughs in H.I.V. vaccine research were reported at the

meeting. Scientist also said that as clinical trials of existing drug combinations were extended a few months beyond the time period reported at an international AIDS meeting in Vancouver last July, the results were continuing to be good. Several studies are about to begin that will seek inexpensive, easy ways to prevent the transmission of H.I.V. from mothers to infants. Each year, hundreds of thousands of newborns acquire AIDS this way. One study will test whether a drug, nevirapine, given once to a mother during labor and to a baby shortly after birth, can prevent such transmission. The treatment, which cost $2, would be affordable everywhere, said Dr. John L. Sullivan of the University of Massachusetts Medical School in Worcester. The existing combination regimens are extremely demanding, in part because patients must swallow dozens of pills a day. Some medication must be taken on an empty stomach and others with food. Many participants said they had come to believe that when a therapy failed in a patie

nt, any newly prescribed regimen should include at least two drugs that the patient had never taken. However, that strategy cannot work for the many patients who have taken virtually every licensed and experimental drug and who desperately need new drug, Dr. Harvey J. Makadon, an AIDS expert at Beth Israel Hospital in Boston said in an interview. Dr. Ann Collier of the University of Washington in Seattle showed some optimism. "There is hope in the Hype," she said as she summarized the progress with a variety of experimental anti-H.I.V. drugs in the three existing classes and the prospects of additional classes of drugs. An ideal anti-H.I.V. drug would be inexpensive, easy to manufacture, simple to take, well tolerated by patients, unlikely to lead to resistant strains of H.I.V., capable of getting into all tissues of the body easily and independent of the action of other drugs, and it would not lead to adverse reactions resulting from drug interactions. The hope is for a drugs that a patient would have to ta

ke only once to twice a day. No drug comes close to meeting those criteria, Dr. Collier said. The experimental drugs that Dr. Collier spoke about generally had no names but were known instead by numbers or letters in the alphabet; they are made by several companies. They have been studied for only for a short period and in small numbers of patients. Scientists said the experimental drugs were unlikely to be licensed for several years, if ever. Agouron Pharmaceuticals of La Jolla, Calif., has asked the Food and Drug Administration to license its experimental protease inhibitor, Viracept, which some patients may find easier to take than other such drugs. Scientists are trying to develop drugs targeted at an enzyme known as integrase in H.I.V., and more basic research is needed to identify additional targets within the machinery of H.I.V., the participants said. Many leaders in AIDS research are concerned that research is moving so fast that trials may still be testing some drugs that are not the best targets f

or research. Dr. Robert T. Schooley, an official of the meeting and an AIDS scientist at the University of Colorado Health Sciences Center in Denver who is involved in AIDS clinical trials, said experts planned a systematic review of the trials to determinate whether improvements could be made. Dr. Anthony S. Fauci, who heads the National Institute of Allergy and Infectious Diseases, which oversees Federal financed clinical trials, said trials that had a problem would be revised or stopped. Dr. Fauci estimated that "about a dozen" such trials would be reviewed in the next several weeks. Dr. Joep M.A. Lange, a leading AIDS expert at the Academic Medical Center in Amsterdam, urged his colleagues to improve the quality of the clinical trials that form the basis of licensing drugs. Dr. Lange provoked the participants by contending that the policies of regulatory agencies, greed and stupidity from many quarters had led scientists to test "suboptimal therapies." Dr. Lange criticized some drug companies for insisti

ng on testing "incestuous combinations" of drugs made by the same companies for failing to report full information about new drugs. But Dr. Lange declined in an interview to identify any such drug companies or regulatory agencies or to provide specific examples of poorly designed clinical trials. "If the trials are successful, they will be published immediately, but industry has a tendency to hold up data if they don't look so good," he said. Dr. Lange said journals that declined to publish reports of studies that reached negative conclusions were part of the problem. He said industry should be required to try to publish promptly all relevant data about products.