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# FDA OK’s Dovato for Replacement HIV Regimen
- URL: https://www.fdaweb.com/fda-oks-dovato-for-replacement-hiv-regimen/
- Published: 2020-08-07T12:00:00.000Z
- Updated: 2026-09-14T16:24:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147388

FDA has approved ViiV Healthcare’s Dovato (dolutegravir/lamivudine) as a complete regimen for treating HIV-1 infection to replace the current antiretroviral regimen in adults who are virologically suppressed on a stable regimen with no history of treatment failure and no known resistance to the individual components of Dovato. The single tablet, two-drug regimen allows adults with HIV to manage their virus without a third antiretroviral, the company says. Dovato was first approved 4/2019 as a complete regimen for treating HIV-1 infection in adults with no antiretroviral treatment history and with no known resistance to the individual components of Dovato.

Approval was based on data from the Phase 3 TANGO study, which demonstrated adults with HIV-1, who had maintained virologic suppression for at least six months on a regimen of at least three drugs, were able to maintain similar rates of virologic suppression after switching to Dovato, compared with those who continued the original regimen, ViiV says. The safety results for those who switched to Dovato were consistent with the product labeling for dolutegravir and lamivudine, it adds.