doravirine, lamivudine, and tenofovir disoproxil fumarate

FDA Drug Profile — DELSTRIGO

Drug Details

Generic Name
doravirine, lamivudine, and tenofovir disoproxil fumarate
Brand Names
DELSTRIGO
Application Number
NDA210807
Sponsor
MSD International GmbH
NDC Codes
2
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
DORAVIRINE, LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE

Indications and Usage

1 INDICATIONS AND USAGE DELSTRIGO ® 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 )