Phase III TANGO study of Dovato shows efficacy in HIV-1 at three-years.

At three years, no participants on dolutegravir/lamivudine (0% [0/369]) met confirmed protocol-defined virologic failure, versus three participants (<1% [3 372]) on the taf-based regimen. no resistance mutations were reported in either arm.></1%>

These findings demonstrated the non-inferiority of dolutegravir/lamivudine compared to continuation of TAF-based regimens in the Intention to Treat-Exposed (ITT-E) population (defined as all participants randomised to the study), based on the proportion of participants with plasma HIV-1 RNA at least 50 copies per millilitre (c/mL) at Week 144 (Snapshot virologic failure: 0.3% [1/369] vs 1.3% [5/372]; adjusted difference: -1.1% [95% CI: -2.4%, 0.2%] for the dolutegravir/lamivudine and TAF-based regimen arms, respectively). In the ITT-E population, both treatment arms showed a high proportion of participants with plasma HIV-1 RNA <50 c ml, with dolutegravir lamivudine demonstrating non-inferior virologic suppression to the taf-based regimen (85.9% [317 369] vs 81.7% [304 372], respectively; adjusted difference: 4.2% [95% ci: -1.1%, 9.5%]).></50>

Overall adverse event (AE) rates were similar between the study arms, with more drug-related grade 2-5 AEs with dolutegravir/lamivudine versus the TAF-based regimens arm (6% [21/369]) vs 4% [13/371], respectively). Data were presented at IDWeek 2021, being held virtually 29 September - 3 October.