| Document Date: 2015-01-27 17:10:16
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Company Gilead Sciences Inc. / Gilead Sciences LLC / Bristol-Myers Squibb / / Event FDA Phase / / Facility Laboratory Abnormalities / / IndustryTerm hepatitis B therapy / machinery / fixeddose combination product / treatment of HIV / combination product / / MedicalCondition inflammatory response / DF / Fanconi syndrome / severe hypophosphatemia / mild-to-moderate rash / HIV / headache / HBV / Mycobacterium avium infection / seizures / liver failure / rash resolves / renal tubular injury / hallucinations / nausea / skin rash / hepatitis B / Stevens-Johnson syndrome / Arthralgias / hepatic dysfunction / fatigue / drowsiness / Obesity / erythema multiforme / residual opportunistic infections / clinically significant hypersensitivity / hypersensitivity / diarrhea / osteomalacia secondary / Graves’ disease / Hypersensitivity ATRIPLA / liver disease / renal dysfunction / Steatosis Lactic acidosis / hepatic disease / Immune reconstitution syndrome / Autoimmune disorders / insomnia / central obesity / Convulsions / Immune Reconstitution Syndrome Immune reconstitution syndrome / amnesia / Guillain-Barré syndrome / Carcinogenesis / Hypophosphatemia / chronic HBV infection / Pneumocystis jirovecii pneumonia / pre-existing hepatic disease / muscle pain / confluent rash / C infection / fever / pain / stupor / Lactic acidosis / severe rash / severe depression / hepatic failure / pancreatitis / POST TREATMENT EXACERBATION OF HEPATITIS B / osteoporosis / osteomalacia / infection / dizziness / depression / Rash / chronic hepatitis B / acute renal failure / polymyositis / tuberculosis / / MedicalTreatment antiretroviral treatment / antiretroviral therapy / alternative therapy / contraception / Barrier contraception / renal replacement therapy / / Organization FDA / / / Product Combivir / efavirenz / EMTRIVA / zidovudine / Trizivir / abacavir sulfate / SUSTIVA / TRUVADA / Vitamin D / HEPSERA / Epivir / rifampin / Epzicom / Epivir-HBV / tenofovir disoproxil fumarate / phenytoin / nevirapine / lamivudine / VIREAD / Didanosine / ATRIPLA / / Technology Pharmacokinetics / / URL www.fda.gov/medwatch / /
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• New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Assess estimated creatinine clearance before initiating treatment with ATRIPLA. In patients at risk for renal dysfunctio