Unregistered User If this is not your name, click here.
		Contact Us | Order Now | Journals | Bookstore | Register a colleague
	Select a ChannelAcneAIDS and HIVAllergy OtherAlzheimer'sAnaesthesiology OtherAngina Pectoris/MIAnxietyArthritis OtherAsthmaBack PainBacterial InfectionsBladder CancerBone Marrow TransplantationBreast CancerCardiology OtherCataractCell TransplantationCervical CancerCholesterol/Lipid disordersCirrhosisClinical PharmacologyColorectal CancerCongestive Heart FailureContact DermatitisContraceptionCOPDCystic FibrosisDental and Oral DisordersDepressionDermatology OtherDiabetesDialysisEating DisordersElbowEmergency MedicineEndocrinology OtherEpilepsyErectile DysfunctionFibromyalgiaGastro OtherGeneticsGenitourinary OtherGeriatricsGERD/GastritisGlaucomaH. Pylori/UlcerHaematology OtherHair LossHeadachesHepa/Biliary OtherHepatitisHipHRTHypertensionIBDImmunologyInfectious OtherInfertilityIntensive CareIrritable Bowel SyndromeKneeLeukemiasLiver CancerLung CancerLupusLymphomasMelanomaMenopauseMultiple Sclerosis Nephrology OtherNeurologic OtherNutritional / Metabolic OtherOb/Gyn OtherObesityOncology OtherOphth. OtherOphthalmic SurgeryOrgan TransplantationOrthopaedics OtherOsteoarthritisOsteoporosisOtitisOtorhino. OtherOvarian CancerPaediatricsPainPancreatic CancerParkinson'sPregnancyProstate CancerPsychiatry OtherPulmonary OtherRadiologyRenal CancerRenal FailureRespiratory InfectionsRheumatoid arthritisRheumatology OtherRhinitisSchizophreniaShoulderSleep ApnoeaSleep DisordersSpineStrokeSTDsSurgeryThyroid DisordersTransfusionTransplant Surgery OtherTraumaUrinary IncontinenceUrinary tract infectionsVaccinologyVascular DisordersViral Infections

SEARCH   News Bookstore Medline The Web Meetings & Congresses Complete Doctor's Guide    EXPLORE :    All News   All Webcasts   All Cases   All Meetings & Congresses   All Medical Resources New drugs / indications English Dictionary Medical Dictionary Thesaurus Warning | Privacy | Awards  Favourite Journals  Click here to choose your favourite journals  Favourite Sites  Click here to choose your favourite sites  Languages  Select languageEnglishFrançais

FDA Approves Twice-Daily Dosing Of Viracept For HIV LA JOLLA, CA -- November 30, 1999 -- Agouron Pharmaceuticals, Inc. today announced that the Food and Drug Administration (FDA) has approved twice daily dosing (BID) of Viracept(R) (nelfinavir mesylate) for the treatment of HIV infection. Approval supports 1250mg BID dosing of Viracept based on data that showed comparable anti-HIV effects and safety to the previously approved 750mg three times daily dosing (TID). "We are gratified that the FDA has approved twice daily dosing for Viracept," said Peter Johnson, Agouron's president and chief executive officer. "This simpler and more convenient dosing schedule for Viracept, that preserves its safety, tolerability and anti-HIV potency, will further enhance the utility of the most extensively prescribed HIV protease inhibitor in the United States." The clearance was based principally on interim results from a pivotal phase III trial involving more than 500 patients that showed similar decreases in plasma HIV RNA and increases in CD4+ T cell counts between 1250mg BID and 750mg TID dosing of Viracept and a similar safety profile, when used in combination with standard doses of Zerit(R) (d4T or stavudine) and Epivir(R) (3TC or lamivudine). Viracept is indicated for the treatment of HIV infection when antiretroviral therapy is warranted. This indication is based on analyses of surrogate marker changes in patients who received Viracept in combination with nucleoside analogs or alone for up to 24 weeks. At present, there are no results from controlled trials evaluating the effect of therapy with Viracept on clinical progression of HIV infection, such as survival or the incidence of opportunistic infections. Viracept is generally well-tolerated when taken 1250 mg BID or 750 mg TID. In study 542, diarrhea of moderate or greater intensity occurred in 14 percent to 18 percent of patients receiving Viracept 1250 mg BID or 750 mg TID with stavudine or lamivudine. New onset or exacerbation of diabetes mellitus and hyperglycemia, changes in the distribution of body fat and increased bleeding in patients with hemophilia types A and B have been reported with protease inhibitors. Related Link: Viracept and Agouron Pharmaceuticals, Inc. E-mail this page to a friend or colleague! To print, use this version