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
Further information
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