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AIDS drug approved, vaccine tested.

AIDS drug approved, vaccine tested

Both the treatment and prevention ofAIDS took another step forward last week with the announcement of federal approval for sales of an AIDS drug and a report that an experimental vaccine had been injected into humans.

A drug that does not cure AIDS butappears to prolong the lives of some of its victims was approved for prescription use last week by the Food and Drug Administration (FDA). Azidothymidine (AZT)--made under the brand name Retrovir by the Burroughs Wellcome Co. of Research Triangle Park, N.C.--is already being used with FDA's blessing by thousands of AIDS patients in the United States.

When a study begun early last year totest AZT's efficacy showed promissing results, the research project was discontinued and the drug was made more widely available (SN: 9/27/86, p. 196). Only days before the AZT decision, the FDA announced it would propose a rule change that would speed approval for drugs that were considered experimental but that caused improvement in terminally ill patients (SN: 3/21/87, p.189). The FDA approval was preceded this month by similar government action in Great Britain and France.

Treatment with AZT, however, is notexpected to be the last word in AIDS drug development. It appears to be effective in a limited group of AIDS patients. Annual costs for the AZT treatment have been estimated to be between $7,000 and $10,000 per patient. And, because the drug can cause immune system suppression and anemia in recipients, alternative treatments are being studied. Among those are ribavirin (SN: 1/5/85, p. 7) and dideoxycytidine, which appears to inhibit the AIDS virus's ability to infect cells. The latter drug is in preliminary clinical trials, with results expected within a few months.

A combination of drugs eventually maybe required to treat AIDS, but even that prospect is complicated. A report in the March 13 SCIENCE suggests that ribavirin hampers activity of AZT.

Despite its disadvantages, AZT is significantas the first approved treatment of the fatal disease. According to Robert E. Windom, an assistant secretary in the Department of Health and Human Services, most AIDS patients are expected to qualify for AZT use under the FDA-approved indications accompanying the approval.

And in the first reported experimentaltrial of an AIDS vaccine in humans, a French scientist has injected himself with a vaccine made by inserting a gene for the AIDS virus envelope into vaccinia virus. Daniel Zagury of the Pierre and Marie Curie Institute in Paris and his co-workers say in a letter in the March 19 NATURE that after the injection, they combined a sample of Zagury's blood in vitro with the AIDS virus and found that the vaccine had activated his immune system against AIDS.

His immune response (both antibodyproduction and cell-mediated immunity) was measured for nine weeks following the primary immunization. The scientists detected not only antibodies against the strain of AIDS virus used, but also heightened blood lymphocyte responses when using Zagury's blood in subsequent tests. The cellular response also was mounted against a very different strain of AIDS virus--an important aspect, given the virus's ability to mutate rapidly. No adverse affects, such as body temperature changes, were observed after injection, say the scientists.

According to the report, booster shotsof the vaccine have been given to Zagury and some of a "small group' of volunteers immunized in Zaire, where the work is being done. The results of this study do not show that the vaccine could actually prevent AIDS, but they do suggest that the two-pronged immune system may be enticed to subdue the lethal virus.

Clinical trials of AIDS vaccines in theUnited States could begin this year, according to Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. Fauci cautions that even if early trials began soon, a widely available vaccine probably would not be reality until the mid-1990s.
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Author:Edwards, Diane D.
Publication:Science News
Date:Mar 28, 1987
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