FDA approves sNDA for Delstrigo in HIV patients.- Merck

Merck announced that the FDA approved supplemental New Drug Application (sNDA) for Delstrigo (doravirine, tenofovir DF, 3TC (lamivudine) as a complete regimen) that expands the indications to include adult patients with HIV-1 infection 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. Delstrigo is a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg). Delstrigo does not cure HIV-1 infection or AIDS. Delstrigo was approved in the United States on August 30, 2018 for the treatment of HIV-1 infection in adults with no prior antiretroviral treatment history.

Delstrigo is contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of Delstrigo. Delstrigo is contraindicated in patients with a previous hypersensitivity reaction to 3TC.