To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Zerit And Videx As First Line HIV Therapy URL: http://www.pslgroup.com/dg/129526.htm Doctor's Guide September 8, 1999
PRINCETON, NJ -- Sept. 8, 1999 - The United States Food and Drug Administration has approved new indications for Bristol-Myers Squibb's currently marketed nucleoside analogues Zerit(R) (stavudine) --also known as d4T -- and Videx(R) (didanosine) -- also known as ddI. Each of these products may be used as a first-line component of a combination antiretroviral therapy regimen for HIV-I infected patients. The approval reflects current HIV treatment guidelines, which recommend initiating therapy with two nucleoside analogues plus a protease inhibitor or the non-nucleoside analogue efavirenz. The approvals of Zerit and Videx each as a component of combination antiretroviral regimens for first-line and subsequent treatment of HIV infected patients are based on these agents' proven efficacy and durability. Furthermore, the approvals of Zerit and Videx suggest that these two agents can be used as a dual-nucleoside foundation of first-line combination therapy. The major toxicity of Videx is pancreatitis, which has been fatal in some cases. Other toxicities include retinal changes and optic neuritis. Patients treated with Videx in combination with stavudine may be at increased risk for adverse events such as pancreatitis, peripheral neuropathy and liver function abnormalities. Lactic acidosis and severe hepatomegaly with steatotis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including didanosine and other antiretrovirals. The major clinical toxicity of Zerit is peripheral neuropathy which may resolve if stavudine is withdrawn promptly. Patients treated with Zerit in combination with didanosine may be at increased risk for adverse events such as pancreatitis, peripheral neuropathy and liver function abnormalities. Lactic acidosis and severe hepatomegaly with steatotis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including stavudine and other antiretrovirals. Related Links: Zerit, Videx and Bristol-Myers Squibb. --------------------------------------------------------------------------------------------- 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.