New drug shows promise against resistant HIV strain

In trials, T-20 helped cut virus, boost white cells

July 09, 2002|By NEW YORK TIMES NEWS SERVICE

BARCELONA, Spain - A novel experimental drug showed highly promising results in two large late-stage trials, offering new hope for thousands of patients who are infected with drug-resistant AIDS virus, scientists reported at the 14th International AIDS Conference here yesterday.

The drug, T-20 or Enfuvirtide, is a member of a new class of drugs called fusion inhibitors that fight the human immunodeficiency virus, which can lead to AIDS. When added to combinations of standard drugs, T-20 reduced high levels of HIV in the blood in at least twice the percentage of patients with documented resistant virus than among those who took the standard drugs.

The drop exceeded the amount the study expected, said the researchers, who conducted the trials at 112 hospitals in the United States, Europe, Australia and South America.

Also, the T-20 combination led to an increase in the white blood cells that HIV destroys.

AIDS experts welcomed the news about T-20 because they have long pleaded for pharmaceutical companies to develop classes of drugs to help save the lives of the thousands of patients who are infected with resistant HIV.

Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases in Bethesda, Md., said the findings "are important because they are proof of concept" that infusion inhibitor-type drugs can work.

The trials "were meticulously done by meticulous researchers," Fauci said in an interview.

"Any time you get a drug aimed at a new target in a virus it's good news because it provides another roadblock to the virus," Fauci said.

The Food and Drug Administration has given T-20 fast-track designation, meaning it will expedite data filed as part of applications of drugs for marketing.

If licensed, T-20 would become the fifth class of anti-HIV drugs approved for standard use. "That would greatly broaden therapeutic options" for fighting AIDS, Fauci said, because it probably would allow doctors to expand the more than 100 combinations of anti-HIV drugs possible.

But because the T-20 trials lasted 24 weeks, the long-term benefits and dangers of the drug are not known. Once started, lifetime treatment of HIV is needed, AIDS experts say.

So HIV resistance to T-20 could eventually become a problem, Fauci and other AIDS experts said.

T-20 is a synthetic drug that has been developed by Trimeris and Roche. Dr. David Reddy, a Roche official, said at a news conference that T-20 is the most complex drug the industry has ever produced.

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