United Press International - Thursday, 13 July 2000
Michael Smith, UPI Science News

Cal Cohen of Harvard Medical School said a new study shows T-20, a so-called fusion inhibitor, has few side-effects and apparently potent activity against HIV, the virus that causes AIDS.

Seventy patients, who were already resistant to most other drugs, took T-20 twice a day by injection, he said. All the patients were also on other medication regimes and several dropped out because of side-effects attributed to the other drugs.

But after 48 weeks, Cohen said, more than half of those who remained showed a drop by a factor of 10 in the level of virus in their blood. About one in three had their virus drop below the level of detectability.

Fusion inhibitors work by preventing the virus from entering its target cells, the immune cells known as CD4s. All other anti-HIV drugs work after the virus has already entered the CD4 cells.

Although T-20 is early in the testing process, Cohen said it has enormous promise: "This is a new class of drugs," he said. "Clearly, they are urgently needed by patients who are resistant to other drugs." The drug is being developed by Trimeris, Inc. of North Carolina and the pharmaceutical giant Hoffman-La Roche.

Although the study was primarily aimed at studying the safety of the drug, Cohen said many of the patients showed dramatic responses. One man, already blind in one eye from an AIDS-related infection, was resistant "to every single antiretroviral drug," he said, had high levels of virus in his blood and had almost no CD4 cells left.

Now, Cohen said, the man has undetectable levels of virus in his blood and his CD4 count has rebounded to near normal levels. "He looks better than I do," Cohen said.

The drug is a small molecule that is easily broken down by stomach acid, he said, so it is not given in pill form like other anti-HIV drugs. Instead, the patients must have subcutaneous injections twice a day.

But, Cohen said, few of the patients complained about having the injections, which they performed themselves.

"After a year, 75 percent said the process was not a problem," he said.

In other drug news Thursday:

--South African investigators said a drug derived from coal tar has passed a short safety and dosing test in 36 patients. Immunologist C. E. Van Rensburg of the University of Pretoria said the drug -- oxihumate -- had no side-effects.

But in the two-week study, she said, the researchers did not see any changes in virus levels or CD4 counts, although in the lab it inhibits reproduction of HIV.

--An American researcher, Genevieve Chavreul of the V2000 Corp. of Pasadena, Calif., said a drug invented by Thai investigators shows promise against HIV in people who have never been treated with antiretroviral drugs.

In a study of 80 people treated with V-1, she said, all had recovered and none had died -- a result she found "impressive."

But Clavreul added the early study was seriously flawed and needs to be re-done to world standards before the V-1, which she said may stimulate the immune system, can be considered a potential therapy for HIV infection.
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