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ViiV Healthcare Presents Positive Data from Phase IIIb/IV Study of Dolutegravir vs Darunavir in Treatment-Naive Adults with HIV-1
Date:9/12/2013

DENVER, Sept. 12, 2013 /PRNewswire/ -- ViiV Healthcare today announced initial results from the Phase IIIb/IV FLAMINGO (ING114915) study. This open-label study, for the first time, 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. Both treatment arms were administered with investigator-selected dual NRTIs. 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 (HIV-1 RNA <50 copies/mL, the primary endpoint of the study per FDA snapshot) compared to those treated with the darunavir regimen (83%, adjusted treatment difference [95% CI] 7.1% (0.9%, 13.2%); P=0.025; N=242 in each arm). 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4%, and rates of treatment withdrawal for other reasons (such as protocol deviation, lost to follow-up or consent withdrawn) were 2% versus 5%. There were no treatment-emergent primary viral mutations leading to treatment resistance in either study arm. These data were presented at the 53rd International Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, Colorado.1 

"These new clinical data are an important addition to our scientific understanding of dolutegravir," said Dr John Pottage, Chief Medical Officer, ViiV Healthcare. "This is the first study in our clinical programme to compare dolutegravir to a boosted protease
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SOURCE ViiV Healthcare
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