Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.
Wall Street Journal - February 9, 2006
Marilyn Chase, marilyn.chase@wsj.com
The new drugs target one of the few features of HIV that doesn't quickly shift its shape to evade treatment.
Merck & Co. of Whitehouse Station, N.J., and Gilead Sciences Inc. of Foster City, Calif., are vying to be first to market with the new class of AIDS drugs, called integrase inhibitors. These drugs attack HIV's integrase, an enzyme that lets the virus merge with human DNA. So far, the drugs seem to work even in patients whose virus has grown resistant to other drugs.
HIV's relentless mutation is driving a quest for new antiviral drug discovery. Although there are more than 20 drugs on the market, about three-fourths of all people on treatment for HIV harbor some drug-resistant virus.
Currently Merck is in the lead with clinical trials of its compound code-named MK-0518, with Gilead's drug GS-9137 in hot pursuit and others trailing. While Merck's drug may not lead to a financial windfall, it could provide new options for patients and a morale boost for the company, which is besieged by lawsuits over its withdrawn painkiller Vioxx, and a dwindling of blockbuster hits.
The Merck drug study compared MK-0518, combined with a drug cocktail, to a placebo with a drug cocktail in people with multiple-drug-resistant virus and a history of treatment failure. In 80 patients treated for 16 weeks, a majority of those taking MK-0518 had their virus levels drop to nearly undetectable levels compared with just 19% of the placebo-control groups.
"We haven't seen any safety signals of concern" with MK-0518, said Robin Isaacs, who directs Merck's integrase-inhibitor program.
Michael Saag, a professor of medicine at the University of Alabama at Birmingham, called Merck's drug results "quite robust." San Francisco AIDS-drug advocate Martin Delaney agreed, but said short-term safety results should be viewed with caution.
Gilead also presented promising data here on its compound GS-9137. In an early study of safety and efficacy, researchers said that 30 HIV patients taking 10 days of GS-9137 experienced as much as a 99% drop in virus compared with smaller reductions among 10 patients taking a placebo.
The next step is larger studies of efficacy for both drugs later this year. Merck said that pending completion of such studies, it plans to apply for Food and Drug Administration approval sometime in 2007.
060209
WJ060201
Copyright © 2006 - The Wall Street Journal. Reproduction of this article (other than one copy for personal reference) must be cleared through the WSJ Permissions Desk.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, the National Library of Medicine, Pacific Life Foundation and donations from users like you.
Always watch for outdated information. This article first appeared in 2006. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS 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 ©1980, 2006. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .