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Chemistry / Organofluorides / Fixed dose combination / HIV/AIDS / Sexually transmitted diseases and infections / Tenofovir / Emtricitabine / Antiretroviral drug / Pre-exposure prophylaxis / Gilead Sciences / Medicine / Health


CrCl is below 60 mL/min. If a decrease in CrCl is observed in uninfected individuals while using TRUVADA for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use[removed]HIGHLIGHTS
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Document Date: 2013-12-17 08:54:34


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Company

Gilead Sciences Inc. / HIV / /

Event

FDA Phase / Reorganization / /

IndustryTerm

hepatitis B therapy / healthcare / food / Treatment of HIV / /

MedicalCondition

DF / Fanconi syndrome / syphilis / headache / HBV / liver failure / dysfunction / acute viral infection / nausea / skin rash / hepatitis B / Arthralgias / fatigue / injury / Obesity / diarrhea / liver disease / renal dysfunction / infections / Immune reconstitution syndrome / abdominal pain / Autoimmune disorders / insomnia / negative infection / pneumonia / opportunistic infections / disease / hypophosphatemia / Carcinogenesis / acute HIV infection / POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B / fever / LACTIC ACIDOSIS / pancreatitis / osteomalacia / osteoporosis / infection / dizziness / depression / gonorrhea / rash / chronic hepatitis B / acute renal failure / syndrome / inflammatory / polymyositis / tuberculosis / /

MedicalTreatment

antiretroviral treatment / antiretroviral therapy / vaccination / hemodialysis / renal replacement therapy / /

Organization

FDA / /

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Position

counsel / /

Product

Combivir / EMTRIVA / zidovudine / Trizivir / abacavir sulfate / TRUVADA / Vitamin D / HEPSERA / Epivir / Epzicom / Epivir-HBV / tenofovir disoproxil fumarate / lamivudine / VIREAD / Didanosine / ATRIPLA / HEPSERA® / HIV-1 / /

Technology

antibodies / Pharmacokinetics / /

URL

www.fda.gov/medwatch / /

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