Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
 |
Wall Street Journal - October 4, 2001
David P. Hamilton, Staff Reporter of The Wall Street Journal
The panel didn't take a formal vote but voiced support for the drug, which targets reverse transcriptase, an enzyme crucial to the replication and spread of HIV. The panel's opinion isn't binding, although the FDA frequently follows the guidance of its advisory panels. The panel's discussion bolsters chances that physicians will soon have a new way to treat AIDS cases that have grown resistant to other drugs.
More than five years ago, the appearance of potent antiviral compounds fundamentally altered the nature of the AIDS epidemic. Where HIV infection was once a virtual death sentence, combination therapy with a variety of drugs that inhibit HIV replication has since restored health and normal lives to hundreds of thousands of AIDS patients.
But HIV, the human immune deficiency virus that causes AIDS, mutates rapidly, allowing some strains of the virus to develop resistance to combination therapy.
Many cases of resistance result when patients skip doses of their daily antiviral drugs -- sometimes as many as 12 pills a day -- allowing mutant strains of the virus to survive and replicate into resistant strains.
A rise in drug-resistant AIDS cases has spurred a global search for new antivirals to which HIV hasn't yet adapted and that are easier for patients to take. Viread, should the FDA approve it, could fit the bill on both counts.
Taken as a pill once a day, Viread was shown in a clinical test of 552 patients to lower the quantity of HIV particles in the blood of "highly treated" AIDS patients who had taken antiviral medications for an average of 5.4 years.
In that same study, Gilead reported that only 3% of the patients who received Viread developed resistance to the drug after 24 weeks. Viread treatment also appeared to reduce the incidence of resistance to another class of anti-HIV drugs known as protease inhibitors.
The advisory panel, however, split on whether to approve the drug for "front-line" treatment because it has so far only been tested in patients that have received other HIV drugs. Nevertheless, Gilead officials believe Viread sales should allow the 13-year-old company to achieve profitability.
The Nasdaq Stock Market halted trading in Gilead shares on Tuesday morning in anticipation of the panel decision. Gilead stock last traded at $56.62.
In addition, Nasdaq postponed by a day its previously announced plan to add Gilead to the Nasdaq 100 Index. Gilead, Foster City, Calif., will be added to the index Friday, replacing Exodus Communications Inc., which filed for Chapter 11 bankruptcy-court protection last week.
Write to David P. Hamilton at david.hamilton@wsj.com1
011004
WJ011001
Copyright © 2001 - The Wall Street Journal. Reproduction of this article (other than one copy for personal reference) must be cleared through the WSJ Permissions Desk.
ÆGiS is made possible through unrestricted grants from Boehringer Ingelheim, iMetrikus, Inc., the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2001. This material is designed to support, not replace, the relationship that exists between you and your doctor.
ÆGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1990, 2000. ÆGIS. All materials appearing on ÆGIS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of ÆGIS, or the party credited as the provider of the content. Feedback/Contact Us.