Dovato (dolutegravir/lamivudine) is the first complete, once daily, single-tablet, 2-drug regimen (2DR) for the treatment of HIV-1 infection in both treatment-naïve and virologically suppressed 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 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 treatment-naïve adults with no known resistance to DTG or 3TC.1 On 6th August 2020, the FDA approved Dovato as a complete regimen for the treatment of HIV-1 infection to replace the current antiretroviral (ARV) regimen in adults who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known resistance to the individual components of Dovato.
Marketing Authorisation was also granted by the European Commission on 3rd July 2019 for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or 3TC.2
Dovato is currently under review by other global regulatory authorities.
- Dovato (dolutegravir/lamivudine) Prescribing Information. US Approval August 2020.
- Dovato (dolutegravir/lamivudine) EU Summary of Product Information. June 2019.