skip nav
National Prevention Information Network
Search Help
Other Searches: Search Organizations | Search Materials | Search Campaign Resources | Search Funding
espaƱol
Share Share this page on Twitter Share this page on Facebook Share this page on LinkedIn View more options to share this page E-mail this page to a colleague Print this page


<< Back

News

Panel Backs AIDS Drug

Abstract
Yesterday, an independent advisory panel recommended accelerated Food and Drug Administration (FDA) approval of Merck & Co.'s drug Isentress (raltegravir) for patients fighting drug-resistant strains of HIV. If approved, Isentress would be the first in a new class of AIDS drugs, integrase inhibitors, which seek to prevent HIV from integrating into human DNA during the replication process. Clinical trials, which lasted 16-24 weeks, involved about 900 patients. In about 600 patients taking Isentress in a cocktail with other AIDS drugs, HIV was suppressed to undetectable levels in the blood of about 62 percent of the individuals. Among the 282 patients taking a standard cocktail plus a placebo, about 34 percent achieved undetectable levels of virus in the blood. Some in the 11-member panel were concerned with cancers and abnormal tissue growths seen in 13 patients taking Isentress. However, Merck and FDA officials said the rate of malignancies seen among the Isentress group is comparable to the rate among other patients with highly resistant HIV. Malignancies seen in those taking Isentress included squamous cell carcinoma and lymphoma. None of the placebo patients experienced malignancies during the trial. However, FDA said the difference could be due to chance. An agency analysis suggested there was an unusually low number of malignancies in the placebo group, rather than a high number in the Isentress group. Several panel members recommended Merck conduct a five-year follow-up study of Isentress to confirm its safety. However, 'overall, based on the data we've seen today, the risk-to-benefit ration seems fairly favorable,' said Dr. Marshall Glesby, a panel member and co-director of Cornell University's HIV Clinical Trials Unit. FDA is not obliged to accept the panel's advice but usually does. The agency could approve Isentress within a few months.
Source
Los Angeles Times
Date of Publication
09/06/2007
Author
Jia-Rui Chong
Article Type
General media
Article Category
National News
Subjects
Clinical Trials
Drug Resistance
HIV/AIDS
Therapeutic Drugs

Disclaimer: NPIN provides this information as a public service only. The views and information provided about the materials, funding opportunities, and organizations do not necessarily state or reflect those of the U.S. Department of Health and Human Services, CDC, or NPIN.

cdcnpin.org News Record #49021

<< Back

CDCNPIN.org

Contact Us
About Us
HIV Content Notice
Privacy Policy
Policies & Disclaimers
Site Index
Help Using the CDC NPIN Web Site

CDC NPIN Searches

Search Organizations
Search Materials
Search Funding Opportunities
Search Campaign Resources
Help Using the CDC NPIN Searches

CDC NPIN Resources

hivtest.cdc.gov
m.hivtest.cdc.gov
findtbresources.org
STD Awareness Microsite
findstdtest.org
AIDS Gov Logo and Link CDC Logo and Link