Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
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Newsday - February 6, 1998
Laurie Garrett - Staff Correspondent
At least three patients who took hydroxyurea and stopped drug therapy have shown no rebound of HIV. Details of six clinical experiments using hydroxyurea in combination with standard HIV and AIDS treatments were reported at this week's Conference on Retroviruses and Opportunistic Infections. And though some of the studies lacked rigorous methodology, according to physicians at the conference, most of the doctors seemed impressed.
"There are going to be a lot of `scrip' written for hydroxyurea this year," a prominent New York AIDS physician was overheard predicting.
Dr. Roger Pomerantz of Philadelphia's Thomas Jefferson University said hydroxyurea might actually prevent the human immunodeficiency virus from making copies of itself.
That doesn't mean it has been officially endorsed. Dr. John Mellors of the University of Pittsburgh sits on the National Institutes of Health committee that reviews and updates standards of HIV care. Earlier this week, Mellors said, the committee rejected the drug - for now, at least. The reason: While viral levels drop dramatically in all patients who take the drug, the numbers of key immune system cells, called CD4, do not always rise. Typically, if an AIDS drug is effective, CD4 levels go up as virus levels drop. "There seems to be a disconnect when using hydroxyurea. And that's disturbing to me," Mellors said.
That remark infuriated Dr. Franco Lori of the Research Institute for Genetic and Human Therapy, located at Georgetown University in Washington and Pavia, Italy. Lori, who has treated AIDS patients with hydroxyurea for two years, said the data available for the generic drug are already stronger than those used by the Food and Drug Administration two years ago in approving four protease inhibitor drugs - all of which are patented.
Hydroxyurea, used in cancer chemotherapy in the United States and Europe, was approved decades ago by the FDA based on studies of thousands of patients.
"And now there are hundreds of patients on hydroxyurea, studies have been presented at dozens of meetings, yet nothing comes out in support" of its official use, Lori complained in an interview.
Lori thinks hydroxyurea prevents the virus from using basic chemicals - called nucleotides - to build copies of its genetic material. "It sort of causes virus starvation," Lori explained. "It doesn't attack the virus directly. It takes out all the pieces the virus needs to replicate."
Of course, destruction of nucleotides may also prevent the body from making copies of its own DNA, and high doses of hydroxyurea wipe out bone marrow cells. By using lower doses, however, researchers in Los Angeles, Kansas, Italy, France and Germany have minimized side effects while knocking out HIV.
The most dramatic effects were seen in a two-year study of 24 AIDS patients that Lori presented yesterday at the conference. All 24 were treated with hydroxyurea, an old AIDS drug called ddI and a protease inhibitor. Virus levels dropped immediately in all the patients to levels below standard detection.
Cell samples from eight of these patients underwent further study in Lori's laboratory and in a Johns Hopkins University lab. Analysis of semen from six of the men showed no evidence of viral infection. Lymph node cells from seven revealed no evidence of virus. Levels of CD4 and CD8, another immune system cell, rose.
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