Wall Street Journal - September 11, 1997
Michael Waldholz

Today's issue of the New England Journal of Medicine, the nation's most prestigious medical journal, publishes the research study that showed a powerful cocktail of drugs -- including Merck & Co. 's potent anti-AIDS drug, the protease inhibitor Crixivan -- rid measurable amounts of the virus in the circulating blood in 28 of 31, or 90%, of test patients who took the drug regimen for a full year.

It was the preliminary news of this study, first reported in The Wall Street Journal and then presented at the International AIDS meeting in July 1996, that persuaded many doctors and patients that a significant advance had occurred in the global fight against Auto Immune Deficiency Syndrome.

"Even though there truly isn't any earth-shattering news in the studies published this week, their formal release to the American medical community in such a high-profile, peer-reviewed journal is very important," said Jeffrey Chodakewitz, an author of the study and director of clinical research at Merck. Said Roy Gulick, a New York University research physician who led the study: "Doctors have heard about this data but this is the first time they can look at it themselves. A lot of physicians don't believe data until they see it published."

In fact, later this month researchers are going to present a report of the same study in which test patients have been followed almost two years. There is much optimism that the virus levels in test subjects will remain undetectable.

Since last year, the treatment of HIV, the AIDS virus, has been revolutionized by the use of a combination drug therapy that largely include one of four protease drugs that have been marketed since early in 1996. Merck reports that about 160,000 HIV-infected people world-wide are taking Crixivan, and an additional 50,000 people are taking other protease drugs produced by Abbott Laboratories, Roche Holding Ltd. and Agouron Pharmaceuticals Inc. All told, the protease drugs, sometimes combined together and sometimes mixed with other anti-AIDS medicines, have had the greatest impact of any treatment in restoring health of many AIDS victims whose disease-fighting immune system is under attack from HIV.

A second report, also published in the Journal, found that in a study of 1,156 patients conducted during 1996, HIV infection progressed to AIDS, or led to death, in only 6% of those who took a three-drug combination of Crixivan and Glaxo Wellcome's drugs, AZT and 3TC. "This report is significant because it tells doctors that reducing HIV levels in patients produces an important [health] benefit," said Scott Hammer, a researcher at Beth Israel Deaconess Medical Center, Boston. "Getting this data out in this manner should put additional pressure on government funding programs to pay for the new combination treatments."

In recent months, AIDS specialists have reported that many doctors around the country are confused as to precisely how to use the new therapies, especially because there are, all told, 11 anti-viral drugs that can be mixed in some type of treatment cocktail. "Right now there is no one place that tells doctors how to use these new drugs," said David Senecheck, a San Francisco AIDS physician who provides consultations to many doctors and has just written a book detailing his advice. "I am especially surprised by how many doctors treating AIDS patients simply don't know what to do with the new drugs."

Indeed, still another article in this week's Journal, an opinion piece written by associate editor Robert Steinbrook, said the two studies published today and the wealth of additional data that has emerged since last year "create new opportunities to control the AIDS epidemic." In what many in the AIDS treatment field believe is especially controversial, Dr. Steinbrook urged mandatory reporting of people infected by HIV as a way to sharply increase the chances of beating back the illness.

Currently, New York and California -- states with the largest HIV-infected populations -- don't require the names of infected people be reported to health departments, even though other infectious agents, such as tuberculosis, are controlled through mandatory reporting.

People have argued that prejudices about the virus demanded confidentiality. But, given the advent of the new combination-drug treatments, the Journal called for a program that protects privacy but alerts many of 650,000 to 900,000 infected Americans unaware they carry the virus that new and powerful therapies are available. Dr. Steinbrook also called for the federal government to step up funding for the new drugs.

Release of the new studies also highlights the limitations of the new therapy. The reports show that some people infected by HIV can develop resistance to the new drugs, and that especially sick patients may require the use of newer or even more potent drugs, several of which are expected to be released during next year.

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