To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: New Invirase Resistance/Cross Resistance Data URL: http://www.pslgroup.com/dg/632A.htm Doctor's Guide February 29, 1996
NUTLEY, N.J., Feb. 29, 1996 -- Preliminary data released today at the FDA antiviral advisory committee meeting suggests that 85 to 90 percent of people taking INVIRASE(TM) (saquinavir mesylate) for one year will still be sensitive to ritonavir and indinavir (protease inhibitors in development). Therefore, INVIRASE(TM) is unlikely to compromise subsequent treatment with ritonavir or indinavir. INVIRASE(TM) is the first approved protease inhibitor and is indicated for treating advanced HIV disease in selected patients. Antiretroviral resistance is a complex and important dimension of AIDS treatment that frequently guides decisions about drug intervention. Research to date has begun to help clinicians understand the resistance profiles of available and investigational antiretroviral agents -- to what extent drugs are prone to resistance, at which viral sites, how quickly resistance develops, and which combinations can help to combat resistance. INVIRASE(TM) has a distinct and consistent pattern of mutation and, for this reason, cross resistance with other protease inhibitors is considered unlikely. In those instances where resistance to INVIRASE(TM) is found, it appears to be associated with changes at protease codons 48 and, most frequently 90. INVIRASE(TM) does not significantly increase the incidence of mutations at sites 10, 46, 63, and 82 -- mutations most commonly associated with resistance to indinavir. Twelve out of 13 viral isolates studied showed no loss of sensitivity to indinavir. The one xception was caused by a mutation at site 82, a variant that is present in a proportion of all untreated patients and is not considered to be a result of INVIRASE(TM) therapy. "Managing HIV requires a long-term strategy. Drug resistance in this context is critical. We don't want to make short-term decisions for patients that limit their options down the road. While much work on cross resistance with protease inhibitors needs to be done, these new data are encouraging for people considering or currently taking INVIRASE(TM)," said Noel Roberts, Ph.D., Antiviral Biology Division, Roche Products Ltd. In clinical studies INVIRASE(TM) was well tolerated by most patients and reported adverse events were mostly of mild intensity. The most frequently reported adverse events, at least possibly related to INVIRASE(TM) treatment and of at least moderate intensity included diarrhea (3.8 percent), abdominal discomfort (1.3 percent) and nausea (1.9). INVIRASE(TM) does not appear to alter the pattern, frequency, or severity of adverse events associated with the use of HIVID and/or Invirase. The clinical relevance of phenotypic and genotypic changes associated with INVIRASE(TM) therapy has not been established. About Roche Roche Laboratories of Nutley, N.J., is the pharmaceutical sales and marketing division of Hoffmann-La Roche Inc., and has a long history in the area of HIV that includes HIVID(R), INVIRASE(TM), Cytovene(R), Roferon-A(R) and Bactrim(TM). Roche is also active in the development of diagnostic tests such as Polymerase Chain Reaction (PCR) technology, that quantifies levels of HIV in blood. Hoffmann-La Roche, a research- based health care company, is a member of the Roche Group headquartered in Basel, Switzerland. A world leader in health care, the Roche Group is dedicated to research and the development and delivery of diagnostic tests, treatment and services for people with life-threatening diseases. CONTACT: Joy Schmitt of Hoffmann-La Roche, 201-562-2202 --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.