Delstrigo FDA Approval History
Last updated by Judith Stewart, BPharm on June 30, 2022.
FDA Approved: Yes (First approved August 30, 2018)
Brand name: Delstrigo
Generic name: doravirine, lamivudine and tenofovir disoproxil fumarate
Dosage form: Tablets
Treatment for: HIV Infection
Delstrigo (doravirine, lamivudine and tenofovir disoproxil fumarate) is a combination of a non-nucleoside reverse transcriptase inhibitor (NNRTI) and two nucleoside analogue reverse transcriptase inhibitors (NRTIs) used for the treatment of HIV-1 infection.
- 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 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.
- The drugs contained in Delstrigo work by inhibiting reverse transcriptase to prevent viral replication of HIV-1.
- Delstrigo tablets are taken once daily with or without food.
- Common adverse reactions include dizziness, nausea, and abnormal dreams.
Development timeline for Delstrigo
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