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This clarification of the DAIDS Table for Grading the Severity of Adult and Pediatric AE’s provides additional explanation of the DAIDS AE Grading Table and clarifies some of the parameters.

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Instructions for using the Table for Grading the Severity of Severity of Adult and Pediatric Adverse Events version 2.0. This version does not visually show changes with highlighting.

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Expedited reporting form for Adverse Events fillable using Microsoft Word.

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TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 30 kg.

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DAIDS Core Risk List (side effects/risks of study drug) for Dolutegravir (DTG) version 2.0, September 2018 The DAIDS Core Risk Lists provides the DAIDS Medical Officer with a list of recommended risks (side effects) that will be used in the DAIDS Sample Informed Consent (SIC) Form. The list draws…

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EDURANT is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated - in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients with HIV-1 RNA less than or equal to 100,000 copies/…

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Efavirenz is a selective non-nucleoside reverse transcriptase inhibitor of human immunodeficiency virus type 1 (HIV-1). Efavirenz is a non-competitive inhibitor of HIV-1 reverse transcriptase (RT) with respect to template, primer or nucleoside triphosphates, with a small component of competitive…

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The following side effects have been associated with the use of efavirenz: A small number of people may experience the following serious psychiatric problems: Depression, which may be severe Suicidal thoughts or attempts (rarely) Aggressive behavior Psychosis-like symptoms, such as abnormal…

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SUSTIVA is a non-nucleoside reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.

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Efavirenz capsules are a non-nucleoside reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection.

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No new or unexpected side effects are observed with the fixed dose combination of EFV 600 mg/FTC 200 mg/TDF 300 mg tablet than those observed when each drug is given separately.

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ATRIPLA, a combination of 2 nucleoside analog HIV-1 reverse transcriptase inhibitors and 1 non-nucleoside HIV-1 reverse transcriptase inhibitor, is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and…

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The fixed-dose combination (Efavirenz 600 mg/ Emtricitabine 200 mg/Tenofovir disoproxil fumarate 300 mg) is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults.

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GENVOYA is a four-drug combination of elvitegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), cobicistat, a CYP3A inhibitor, and emtricitabine and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen…

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DESCOVY is a two-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12…

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No new or unexpected side effects are observed with the FTC 200 mg/TDF 300 mg combination tablet than those observed when each drug is given separately.

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