Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
San Francisco Chronicle - Saturday, October 27, 2001
Tom Abate, Chronicle Staff Writer
Analysts had expected the FDA to approve Viread, but there had been some question about whether the agency would approve it as a treatment for all HIV patients or restrict its use initially to patients who had developed resistance to current AIDS drugs.
AIDS activist Martin Delaney applauded the FDA's decision to let Gilead promote the drug for all HIV patients, including the "treatment-naive" -- those taking AIDS drugs for the first time.
"This is exactly what we had hoped for," Delaney said. "This is going to be an important drug for AIDS treatment at every stage of the disease."
Gilead spokeswoman Amy Flood said the company will begin shipping Viread to pharmacies next week. A year's dose will cost $4,135. She said Gilead will work to get Viread approved for payment by state and private insurance agencies, but that could take weeks or months.
Dr. Stephen Becker, a San Francisco AIDS specialist, treated more than two dozen patients with Viread as part of the clinical trials that led up to the FDA approval. These were patients who were being treated with other medicines and had begun to develop a resistance to them.
Becker said Viread reduced HIV levels in these patients' bloodstreams, without the side effects of current AIDS drugs. These can range from nausea to diabetes.
But Becker said he was not yet ready to prescribe Viread for treatment- naive patients. He said Gilead is conducting clinical trials to ensure that the drug has the same safety and benefit for new AIDS patients as it does for those who are already developing a resistance.
"I would expect the data to be good, but I'll wait to see," Becker said. The company expects data from that 601-patient trial to be available in the first half of 2002.
Yesterday's news was a triumph for Gilead, which suffered a crushing defeat almost two years ago to the day when an FDA advisory panel rejected an earlier AIDS drug because of its side effects.
Gilead released the news after the close of regular trading. Its shares, which have been on the rise for months in anticipation of the approval, slid $1.12 yesterday to close at $67.68. The stock is trading close to its 52-week high. After-hours traders shaved a few cents off its shares.
E-mail Tom Abate at tabate@sfchronicle.com.
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