Policy & Regulation
ViiV Healthcare, Pfizer and Shionogi reveal positive Week 48 results from phase III TANGO study of dolutegravir plus lamivudine
12 July 2019 -

ViiV Healthcare, a global specialist HIV company majority-owned by GSK, in collaboration with United States-based Pfizer Inc and Japan-based Shionogi Limited as shareholders have revealed positive Week 48 results from the phase III TANGO study of dolutegravir plus lamivudine, it was reported yesterday.

The TANGO study was conducted to evaluate whether adults living with HIV-1 who had maintained viral suppression for around six months on a tenofovir alafenamide fumarate-containing regimen of around three drugs, were able to maintain similar rates of viral suppression after switching to the 2-drug regimen of dolutegravir plus lamivudine in a fixed dose combination, compared to continuing the tenofovir alafenamide fumarate -containing regimen. The study met its primary endpoint for non-inferiority, based on the proportion of participants with plasma HIV-1 RNA up to 50 copies per millilitre 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. The complete results from the study will be presented at the 10th International AIDS Society Conference on HIV Science to be held from 21 July to 24 July in Mexico City.