ViiV Healthcare presents positive Tivicay results from HIV study

Positive data has been reported from the Phase IIIb/IV FLAMINGO study of Tivicay (dolutegravir) versus darunavir in treatment of adults with HIV-1 by ViiV Healthcare, the HIV/AIDS joint venture from the UK’s GlaxoSmithKline (LSE: GSK), US drug giant Pfizer (NYSE: PFE) and Japan’s Shionogi (TYO: 4507).

The open-label study compared once-daily regimens containing 50mg dolutegravir with once-daily regimens containing a protease inhibitor (PI) (800mg darunavir boosted with 100mg ritonavir) in treatment-naive adults with HIV-1. Non-inferiority was demonstrated at the 48-week time point between the dolutegravir and darunavir-based regimens. A subsequent, pre-specified testing procedure demonstrated statistical superiority in the dolutegravir treatment arm.

At 48 weeks, a significantly greater proportion of the patients treated with the dolutegravir regimen (90%) were virologically suppressed compared to those treated with the darunavir regimen (83%). Comparing the dolutegravir and darunavir arms, rates of virologic non-response were 6% versus 7% and rates of treatment withdrawal due to adverse events were 1% versus 4%. There were no treatment-emergent primary viral mutations leading to treatment resistance in either study arm.