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FDA approves drug to treat AIDS cancer.


The Food and Drug Administration (FDA) has given two New Jersey companies the OK to manufacture and market the drug alpha interferon as a treatment for Kaposi's sarcoma (KS), a cancer that primarily affects AIDS patients. Alpha interferon, a disease-fighter naturally present in the human body in small amounts, has been artificially produced in large quantities in recent years by gene-splicing techniques. It had previously been approved for the treatment of genital warts and a type of leukemia known as hairy-cell. The companies in question are Hoffmann-La Roche Inc., Nutley, N.J., and Schering-Plough Corp., Kenilworth, N.J. Hoffmann-La Roche calls its version of the drug Roferon(R)-A, while Schering-Plough's brand name will be Intron A(R).

Two recent studies--one conducted in The Netherlands, the other by the FDA and the National Institutes of Health (NIH)--point to the drug's effectiveness, even for those in the disease's advanced stages. The Dutch study treated 28 KS patients with high dosages of alpha interferon every day for eight weeks. Of that number, 26 either showed anti-tumor responses or remained in stable condition. Twelve of the 26 demonstrated significant responses after the initial eight weeks; five of these showed complete responses altogether. The FDA/NIH study tested 21 KS patients with alpha interferon and found similarly positive results: eight (38 percent) showed complete or partial anti-tumor responses; those with advanced numbers of KS cells showed significant tumor reductions (unlike those with considerably fewer cells, who showed few, if any, responses); after 12 weeks of therapy, five of the six complete or partial responders who had had significant amounts of the human immunodeficiency virus (HIV) before treatment, showed 75 percent or greater reductions in HIV amounts (with three of the five showing persistently negative HIV cultures). Both studies proclaim alpha interferon to therefore be an effective treatment against KS. (Lancet, November 26, 1988; II:1214-1222 and IMTS.)

Interferon, first described by two London researchers in 1957, acts as a shield for the body against further viral infection whenever one virus invades the body's cells. This is the commonly accepted reason why people do not become infected with two or more viruses--say, measles and chicken pox--simultaneously. Alpha interferon, when injected as a drug, discourages

the spread of tumor cells and has demonstrated in clinical trials a knack for turning malignant cells into benign ones. Unfortunately, there are initial side effects--such as fever, chills, muscle pain or tenderness, headache and fatigue--but these are considered generally managable effects that tend to subside with continued treatment. Because the recommended dosage of alpha interferon for the treatment of KS is higher than that for hairy-cell leukemia, the cost of such treatment, available by prescription only in self-injecting form, will be considerably higher than before. Hoffmann-La Roche, however, has a payment plan for those unable to afford medical insurance.

KS, discovered more than a century ago by the Austro-Hungarian dermatologist Moritz Kaposi, is seen in nearly one-third of all AIDS patients. Recognizable by purple and brown lesions on the skin, KS is often the first sign that one has AIDS. KS affects a greater number of male homosexual AIDS patients than heterosexual ones, but it is not exclusive. At one time considered quite rare (until the appearance of AIDS), KS can result in death when it infects the lungs or other vital organs.
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Title Annotation:alpha interferon, Kaposi's sarcoma
Publication:Medical Update
Date:Jan 1, 1989
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