Tenofovir approved: Broad indication.On October 26 the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approved Viread (tm) -- generic name generic name n. 1. The official nonproprietary name of a drug, under which it is licensed and identified by the manufacturer. 2. tenofovir disoproxil fumarate tenofovir disoproxil fumarate Viread Pharmacologic class: Nucleoside analog reverse transcriptase inhibitor Therapeutic class: Antiretroviral Pregnancy risk category B , or tenofovir DF. The approval was expected; less expected was the broad indication, which both the company and treatment activists wanted, but which some of the advisory committee had questioned (see "Tenofovir: FDA Hearing on Important New Antiretroviral," AIDS Treatment News #372, October 19, 2001). From the package insert:"INDICATIONS AND USAGE "VIREAD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV-1 RNA RNA: see nucleic acid. RNA in full ribonucleic acid One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic levels and CD4 cell counts in a controlled study of VIREAD of 24 weeks duration and in a controlled, dose ranging study of VIREAD of 48 weeks duration. Both studies were conducted in treatment-experienced adults with evidence of HIV- 1 viral replication despite ongoing antiretroviral therapy. Studies in antiretroviral naive patients are ongoing; consequently, the risk-benefit ratio for this population has yet to be determined. "Additional important information regarding the use of VIREAD for the treatment of HJV HJV Hjemmeværnet (Danish National Guard) HJV Hemojuvelin HJV Hypocritae Jacobeae Virus HJV Highland J-Virus infection: "* There are no study results demonstrating the effect of VIREAD on clinical progression of HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. . "* The use of VIREAD should be considered for treating adult patients with HIV strains that are expected to be susceptible to tenofovir as assessed by laboratory testing or treatment history." A patient-oriented description of the drug appears at: http://www.aidsmeds.com/drugs/tenofovir.htm The Medscape drug-interaction calculator, recently updated to include tenofovir, is at: http://hiv.medscape.coni!Medscape/HIV/DrugInteractions/index.cfm An FDA Talk Paper is at: http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01111.html And the complete package insert can be found on the Gilead site at: http://www.gilead.com/prod_pdf/viread_pi.pdf. |
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