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FDA Approves Zerit And Videx As First Line HIV Therapy 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 The major clinical toxicity of Zerit is peripheral neuropathy which may resolve if stavudine is withdrawn promptly.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. E-mail this page to a friend or colleague! To print, use this version