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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
Company: Merck
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

Sep 20, 2019Approval Merck’s Pifeltro (doravirine) and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) Receive FDA Approval for Use in Appropriate Adults Living with HIV-1 Who Are Virologically Suppressed
Aug 30, 2018Approval FDA Approves Merck’s Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) for the Treatment of HIV-1 in Appropriate Patients

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.