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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

DateArticle
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

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