Skip to main content

Delstrigo FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 24, 2019.

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) a non-nucleoside reverse transcriptase inhibitor (NNRTI) and nucleoside analogue reverse transcriptase inhibitors combination indicated for the treatment of HIV-1 infection.

Delstrigo is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients:

  • 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.

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.