Dovato was approved by the US Food and Drug Administration (FDA) on 8th April 2019 as a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to dolutegravir (DTG) or lamivudine (3TC).  

Dovato is the first approved, once daily, single-tablet, 2-drug regimen (2DR) for the treatment of HIV-1 infection in treatment-naïve adults. Dovato is ViiV Healthcare’s second 2DR, once-daily single-tablet and combines the integrase strand transfer inhibitor (INSTI) dolutegravir (DTG), with the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine (3TC).

Dovato is not approved for use anywhere outside of the US. It is currently under review by other global regulatory authorities. 

Dovato offers people living with HIV an option that uses fewer medications to reduce antiretroviral exposure while still maintaining the efficacy, safety and high barrier to resistance of a traditional DTG-based three-drug regimen. 

[1] Dovato (dolutegravir/lamivudine) Prescribing Information. US Approval 2019.

Prescribing information

Please refer to your country-specific information below:

United States

Prescribing Information and Patient Information Leaflet for Dovato®