TANGO: Three-year Dovato study shows non-inferiority to TAF-based regimens

Viiv Healthcare have announced three-year results from the TANGO study which showed that showed that the two-drug regimen (2DR) Dovato (dolutegravir/lamivudine) continued to demonstrate non-inferior efficacy and a high barrier to resistance compared to continuation of tenofovir alafenamide fumarate (TAF)-based regimens of at least three drugs in virologically suppressed adults living with HIV-1 who had not experienced prior virologic failure.

At three years, no participants on dolutegravir/lamivudine met confirmed protocol-defined virologic failure, versus three participants on the TAF-based regimen. No resistance mutations were reported in either arm.

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, based on the  proportion of participants with plasma HIV-1 RNA more than or equal to 50 copies per millilitre (c/ml) at Week 144 (snapshot virologic failure: 0.3 percent versus 1.3 percent; adjusted difference: -1.1 percent [95 percent CI] for the dolutegravir/lamivudine and TAF-based regimen arms, respectively).

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 (six percent versus four percent, respectively). Rates of AEs were similar between treatment arms at Weeks 48, 96 and 144. The most common drug-related grade 2-5 AEs in the dolutegravir/lamivudine and TAF-based regimens arms were insomnia, increased weight, constipation, depression, flatulence and nausea.

Source: https://www.europeanpharmaceuticalreview.com/news/163421/three-year-dovato-study-shows-non-inferiority-to-taf-based-regimens - last visit: October 2021