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Outline
What is the generic name?
DORAVIRINE, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
What is the Trade Name for DORAVIRINE, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE?
DELSTRIGO
What are the Indications for DORAVIRINE, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE?
- 1 INDICATIONS AND USAGE DELSTRIGO‚Ñ¢ is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: with no prior antiretroviral treatment history, OR to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO [see Clinical Studies (14) ] . DELSTRIGO is a three-drug combination of doravirine (a non-nucleoside reverse transcriptase inhibitor [NNRTI]), lamivudine, and tenofovir disoproxil fumarate (both nucleoside analogue reverse transcriptase inhibitors) and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: with no antiretroviral treatment history, OR to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO. ( 1 )
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References: https://open.fda.gov/
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