DELSTRIGO (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
DELSTRIGO
Date registered
Evaluation commenced
Decision date
Approval time
197 working days (255)
Active ingredients
doravirine; lamivudine; tenofovir disoproxil fumarate
Registration type
EOI
Indication
DELSTRIGO (film coated tablet) is now indicated for the treatment of HIV-1 infection in adult patients:
- With no prior antiretroviral 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 doravirine, lamivudine, or tenofovir.