ViiV's dolutegravir plus lamivudine meets Phase III endpoint

GlaxoSmithKline (LSE: GSK) majority-owned HIV specialist company ViiV Healthcare today 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 two-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 ≥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.