Phase III TANGO study demonstrates control of HIV-1 with a 2-drug regimen of dolutegravir plus lamivudine in virally suppressed patients switching from a 3-drug regimen

ViiV Healthcare, announced positive Week 48 results from its phase III TANGO study . The TANGO study was conducted to assess whether adults living with HIV-1 who had maintained viral suppression for at least six months on a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs, were able to maintain similar rates of viral suppression after switching to the 2-drug regimen (2DR) of dolutegravir plus lamivudine in a fixed dose combination, compared to continuing the TAF-containing regimen.

The study met its primary endpoint for non-inferiority, based on the proportion of participants with plasma HIV-1 RNA greater than 50 copies per millilitre (c/mL) using the FDA Snapshot algorithm at Week 48. No patients met confirmed virologic withdrawal criteria or developed treatment resistance in the dolutegravir plus lamivudine arm of the study. The safety results for the 2DR of dolutegravir plus lamivudine were consistent with the product labelling for the medicines. Full results from the study will be presented at the 10th International AIDS Society Conference on HIV Science (IAS 2019), to be held from 21-24 July in Mexico City.

Comment: ViiV and GSK have been trying to move away market share from Gilead by showing regimens with two drugs are as effective as those with three or more in combination, and the two drug regimen offers less side effects.

Comment:Though Viiv got regulatory clearance for another double combination named Juluca (dolutegravir/rilpivirine) in late 2017, they expect the more recently approved Dovato (dolutegravir/lamivudine) to have greater market success.