本帖最后由 StephenW 于 2010-11-24 15:10 编辑
Just add to liver411. Please note "Truvada is not approved for the treatment of chronic hepatitis B virus (HBV) infection and its safety and efficacy has not been established in patients co-infected with HBV and HIV-1." 补充一点加到liver411。请注意“Truvada是不是为了治疗慢性乙型肝炎病毒批准（HBV）感染及其安全性和有效性尚未确定患者的合作与HBV和HIV - 1感染。”
press release Nov. 23, 2010, 8:30 a.m. EST Gilead Sciences Submits New Drug Application to U.S. FDA for Once-DailySingle-Tablet Regimen of Truvada(R) and TMC278 for HIV-- Product Would Be Second Complete Single-Tablet Antiretroviral Regimen --
FOSTER CITY, Calif., Nov 23, 2010 (BUSINESS WIRE) -- Gilead Sciences, Inc. /quotes/comstock/15*!gild/quotes/nls/gild (GILD
37.22, +0.24, +0.65%) today announced that it hassubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration(FDA) for marketing approval of the single-tablet regimen of Truvada(R)(emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals'investigational non-nucleoside reverse transcriptase inhibitor TMC278(rilpivirine hydrochloride) for HIV-1 infection in adults. If approved, thiswould be the second product that contains a complete HIV treatment regimen in asingle once-daily tablet.
"Combination antiretroviral therapy has dramatically advanced the fieldof HIV medicine, but the need remains for new single-tablet regimens that areeffective, safe and well tolerated," said John C. Martin, PhD, Chairmanand Chief Executive Officer, Gilead Sciences. "Gileadis committed to helping advance HIV treatment by pursuing both scientificresearch and innovative partnerships that will deliver more options to thehealthcare community. We are pleased to work with Tibotec to bring thispotentially important new therapy to people living with HIV."
On July 23, 2010, Tibotec submitted an NDA for U.S. marketing approval of TMC278for once-daily use with other antiretroviral agents. That NDA is supported by48-week data from two Phase III double-blind, randomized studies (ECHO andTHRIVE) that evaluated the safety and efficacy of TMC278 in treatment-naiveHIV-1 infected adults, the majority of whom received TMC278 in combination withTruvada. The Gilead NDA for Truvada/TMC278 is supported by a bioequivalencestudy conducted by Gilead demonstrating thatthe formulation of the single-tablet regimen achieved the same levels ofmedication in the blood as the component products dosed simultaneously asindividual pills.
On September 3, 2010, the European marketing applications for TMC278 and forthe Truvada/TMC278 single-tablet regimen were filed simultaneously by Tibotecand Gilead, respectively.
Gilead entered into a license andcollaboration agreement with Tibotec for the development and commercializationof the single-tablet regimen in July 2009. Subject to regulatory approval,Gilead will assume the lead role in the manufacturing, registration,distribution and commercialization of the single-tablet regimen worldwide,excluding the developing world and Japan. Tibotec will be responsiblefor the commercialization of TMC278 as a stand-alone product and will holdrights to co-promote the single-tablet regimen in these territories. Thecompanies are currently working on an agreement to make the combination productavailable in the developing world.
Truvada/TMC278 is an investigational product and its safety and efficacyhave not yet been established.
Important Product Safety Information About Truvada
Truvada is a fixed-dose combination tablet containing 200 mg ofemtricitabine (Emtriva(R)) and 300 mg of tenofovir disoproxil fumarate(Viread(R)). In the United States, Truvada is indicated in combinationwith other antiretroviral agents (such as non-nucleoside reverse transcriptaseinhibitors or protease inhibitors) for the treatment of HIV-1 infection inadults.
Lactic acidosis and severe hepatomegaly with steatosis, including fatalcases, have been reported with the use of nucleoside analogues alone or incombination with other antiretrovirals including Viread (tenofovir disoproxilfumarate), a component of Truvada. Truvada is not approved for the treatment ofchronic hepatitis B virus (HBV) infection and its safety and efficacy has notbeen established in patients co-infected with HBV and HIV-1. Severe acuteexacerbations of hepatitis B have been reported in patients co-infected withHIV-1 and HBV who have discontinued Truvada. Hepatic function should bemonitored closely with both clinical and laboratory follow-up for at leastseveral months in patients who are co-infected with HBV and HIV-1 anddiscontinue Truvada. If appropriate, initiation of anti-hepatitis B treatmentmay be warranted.
It is important for patients to be aware that anti-HIV medicines includingTruvada do not cure HIV infection or AIDS and do not reduce the risk oftransmitting HIV to others.
Emtricitabine and tenofovir are principally eliminated by the kidneys. Renalimpairment, including cases of acute renal failure and Fanconi syndrome (renaltubular injury with severe hypophosphatemia), has been reported in associationwith the use of Viread. It is recommended that creatinine clearance becalculated in all patients prior to initiating therapy with Truvada and asclinically appropriate during therapy. Routine monitoring of calculatedcreatinine clearance and serum phosphorous should be performed in patients atrisk for renal impairment including patients who have previously experiencedrenal events while receiving Hepsera(R) (adefovir dipivoxil).
Dosing interval adjustment and close monitoring of renal function arerecommended in all patients with creatinine clearance 30-49 ml/min. Truvadashould be avoided with concurrent or recent use of a nephrotoxic agent. Truvadashould not be administered with Hepsera.
Truvada should not be coadministered with Emtriva, Viread, Atripla(R)(efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg)or lamivudine-containing products, including Combivir(R)(lamivudine/zidovudine), Epivir(R) or Epivir-HBV(R) (lamivudine), Epzicom(R)(abacavir sulfate/lamivudine) or Trizivir(R) (abacavirsulfate/lamivudine/zidovudine). In treatment-experienced patients, the use ofTruvada should be guided by laboratory testing and treatment history.
Decreases in bone mineral density (BMD) at the lumbar spine and hip havebeen seen with the use of Viread. The effect on long-term bone health andfuture fracture risk is unknown. BMD monitoring should be considered inpatients with a history of pathologic fractures or who are at risk forosteopenia. Cases of osteomalacia (associated with proximal renal tubulopathyand which may contribute to fractures) have been reported in association withthe use of Viread.
Redistribution/accumulation of body fat has been observed in patients takingantiretroviral medicines. Immune Reconstitution Syndrome has been reported inpatients treated with combination therapy, including Viread and Emtriva, andmay necessitate further evaluation and treatment. Early virologic failure hasbeen reported in HIV-infected patients on regimens containing only threenucleoside reverse transcriptase inhibitors. Patients on a therapy utilizing atriple nucleoside-only regimen should be carefully monitored and considered fortreatment modification.
Coadministration of Truvada and didanosine should be undertaken with caution.Patients should be monitored closely for didanosine-associated adverse eventsand didanosine should be discontinued if these occur. Dose reduction ofdidanosine should be considered, if warranted. Patients on atazanavir andlopinavir/ritonavir plus Truvada should be monitored for Truvada-associatedadverse events and Truvada should be discontinued if these occur. Whenco-administered with Truvada, it is recommended that atazanavir be boosted withritonavir 100 mg. Atazanavir without ritonavir should not be co-administeredwith Truvada.
The most common adverse reactions (incidence greater-than or equal to 10percent) are diarrhea, nausea, fatigue, headache, dizziness, depression,insomnia, abnormal dreams and rash.
The parent compound of Viread was discovered through a collaborativeresearch effort between Dr. Antonin Holy, Institute for Organic Chemistry andBiochemistry, Academy of Sciences of the Czech Republic (IOCB) in Prague and Dr. Erik DeClercq, Rega Institute for MedicalResearch, Katholic University in Leuven, Belgium. Theinventors of Viread have agreed to waive their right to a royalty on sales ofViread and Truvada in the Gilead Access Program countries to ensure that theproduct can be offered at a no-profit price in parts of the world where theHIV/AIDS epidemic has hit the hardest.
For complete prescribing information for Truvada, visit www.Truvada.com.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops andcommercializes innovative therapeutics in areas of unmet medical need. Thecompany's mission is to advance the care of patients suffering fromlife-threatening diseases worldwide. Headquartered in Foster City, California, Gilead hasoperations in North America, Europe and Australia.
Forward-Looking Statement
This press release includes forward-looking statements, within the meaningof the Private Securities Litigation Reform Act of 1995, that are subject torisks, uncertainties and other factors, including risks related to Gilead's ability to successfully commercialize thesingle-tablet regimen of Truvada/TMC278. For example, the FDA, EuropeanMedicines Agency or other regulatory agencies may not approve TMC278 or thesingle-tablet regimen of Truvada/TMC278 for the treatment of HIV-1 infection inadults, and any marketing approval, if granted, may have significantlimitations on its use. Further, Gilead andTibotec may make a strategic decision to discontinue development of thecombination product if, for example, the market for the product fails tomaterialize as expected. These risks, uncertainties and other factors couldcause actual results to differ materially from those referred to in theforward-looking statements. The reader is cautioned not to rely on theseforward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarterended September 30, 2010, as filed with the U.S. Securities and ExchangeCommission. All forward-looking statements are based on information currentlyavailable to Gilead, and Gilead assumes noobligation to update any such forward-looking statements.
U.S.full prescribing information for Truvada is available at www.Truvada.com.
U.S.full prescribing information for Atripla is available at www.Atripla.com.
U.S.full prescribing information for Viread is available at www.Viread.com.
U.S.full prescribing information for Emtriva is available at www.GileadHIV.com.
U.S.full prescribing information for Hepsera is available at www.Hepsera.com.
Truvada, Viread, Emtriva and Hepsera are registered trademarks of GileadSciences, Inc.
Atripla is a registered trademark of Bristol-Myers Squibb & GileadSciences, LLC.
For more information on Gilead Sciences, please visit the company's websiteat www.gilead.com or call Gilead PublicAffairs at 1-800-GILEAD-5 or 1-650-574-3000.
SOURCE: Gilead Sciences, Inc.
Gilead Sciences, Inc. Susan Hubbard, 650-522-5715 (Investors) Cara Miller, 650-522-1616 (Media) Copyright Business Wire 2010
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发表于 2010-11-24 09:46
