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# ViiV sNDA for Dovato as a Switch Treatment
- URL: https://www.fdaweb.com/viiv-snda-for-dovato-as-a-switch-treatment/
- Published: 2019-10-16T12:00:00.000Z
- Updated: 2026-09-15T01:56:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145266

ViiV Healthcare has filed a supplemental NDA for Dovato (dolutegravir and lamivudine) as a switch treatment for HIV-1 infection in virologically suppressed adults on a stable antiretroviral regimen with no treatment failure. Dovato is currently approved as a complete, once-daily, single-tablet regimen for HIV-1 in adults with no antiretroviral treatment history and with no known resistance to either individual drug component.

The submission is based on data from the Phase 3 TANGO study, which demonstrated adults who had maintained virologic suppression for at least six months on a tenofovir alafenamide fumarate (TAF)-containing regimen were able to maintain similar virologic suppression rates after switching to the two-drug regimen Dovato compared to those who continued TAF, the company says. The safety results for those who switched to Dovato were consistent with the product labeling for the regimen, it says.