Positive data from study of Tivicay in Adults with HIV-1

Initial results from the Phase IIIb/IV FLAMINGO study comparing once-daily regimens containing Tivicay (dolutegravir), from Viiv Healthcare, with darunavir boosted with 100mg ritonavir in treatment-naive adults with HIV-1 demonstrated non-inferiority 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 greater proportion of 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%, rates of treatment withdrawal due to adverse events were 1% versus 4%, and rates of treatment withdrawal for other reasons were 2% versus 5%. Data were presented at the 53rd International Conference on Antimicrobial Agents and Chemotherapy.