Skip to main content

Dovato FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved April 8, 2019)
Brand name: Dovato
Generic name: dolutegravir and lamivudine
Dosage form: Tablets
Company: ViiV Healthcare
Treatment for: HIV Infection

Dovato (dolutegravir and lamivudine) is a combination of the integrase strand transfer inhibitor dolutegravir (Tivicay) and the nucleoside analogue reverse transcriptase inhibitor lamivudine (Epivir) used for the treatment of HIV-1 infection in adults.

  • Dovato is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults 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 Dovato.
  • The recommended dose of Dovato is one tablet taken once daily, with or without food.
  • Common adverse reactions include headache, nausea, diarrhea, insomnia, fatigue, and anxiety.

Development timeline for Dovato

Aug  6, 2020Approval ViiV Healthcare Announces FDA Approval of an Expanded Indication for Dovato (dolutegravir/lamivudine), a Complete Two-Drug Regimen for Virologically Suppressed Adults with HIV-1
Apr  8, 2019Approval FDA Approves Dovato (dolutegravir/lamivudine) for HIV-1 Infection in Adults with No Antiretroviral (ARV) Treatment History
Oct 18, 2018ViiV Healthcare Submits New Drug Application to FDA for Single-Tablet, Two-Drug Regimen of Dolutegravir and Lamivudine for Treatment of HIV

Further information

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