Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
Reuters NewMedia, Inc. - Tuesday July 15 12:45 PM EDT
Ransdell Pierson
Peter Johnson, Agouron's chief executive, said in an interview the previously unreleased data strengthened the argument for early treatment and could likely influence FDA guidelines for anti-HIV drugs.
Johnson said the FDA had requested data involving hundreds of patients treated with a combination of Agouron's protease inhibitor Viracept in combination with Glaxo Wellcome Plc's (GLXO.L) reverse transcriptase inhibitors AZT and 3TC.
The clinical data were compiled during a 48-week period beginning in the spring of 1996 at 50 centers in the United States. Other data from the same clinical trials, which are ongoing, were the basis for FDA approval earlier this year of Viracept, which reached the market March 14.
Johnson, in New York for a Montgomery Securities health-care conference, said the HIV virus was undetectable in 96 percent of patients with early infection, defined as less than 50,000 viruses per cubic millimeter of blood.
And among those who responded to the cocktail, 95 percent continued to have undetectable "viral loads" after 48 weeks, he said.
But among patients with longer infections evidenced by 100,000 or more viruses per cubic millimeter, only 81 percent showed absence of detectible virus after treatment.
Among them, only 80 to 85 percent had undetectable virus after 48 weeks.
"This is an analysis we haven't done before and it confirms the supposition that there's compelling reason to seek treatment early," Johnson said.
"This is an additional piece of information that will substantiate the increasingly prominent thought that it's important to hit the virus hard and hit it early," he said.
Johnson said the FDA had also asked manufacturers of other protease inhibitors -- which include Roche Holding AG's (ROCZG.S) Invirase, Merck and Co Inc's (MRK) Crixivan and Abbott Laboratories Inc's (ABT) Norvir -- to submit their own comparative data on early-stage and later-stage patients.
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