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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

inhibitor in treatment-naive patients. PIs are often selected as part of a first-line regimen for treatment-naive patients, so these data provide important information regarding dolutegravir as a treatment choice for these patients."

The most commonly (>10%) reported adverse events in either study arm were diarrheoa (dolutegravir 17% vs boosted darunavir 29%), nausea (16% vs 18%), and headache (15% vs 10%). Study participants on the dolutegravir regimen had significantly fewer Grade 2 or higher abnormalities in fasting LDL-cholesterol (dolutegravir 2% vs darunavir 7%, [p<0.001]). Serious adverse events (SAEs) were reported among 11% and 5% of patients receiving a regimen containing dolutegravir (N=242) or boosted darunavir (N=242), respectively, with one SAE attributed by the investigator to dolutegravir treatment.

FLAMINGO (a Phase IIIb/IV study) follows four Phase III studies, which examined the efficacy and safety of dolutegravir. It is the third study in treatment-naive adults with HIV-1. Data from SPRING-2 (ING113086), SINGLE (ING114467) and VIKING-3 (ING112574) were announced in 2012, and data from SAILING (ING111762) were announced in 2013: these four studies formed the basis of the registration package leading to the U.S. Food and Drug Administration (FDA) approval of Tivicay® on 12 August 2013. Please refer to the full U.S. prescribing and patient information at:
https://www.viivhealthcare.com/media/58599/us_tivicay.pdf  

Important Information About Tivicay® (dolutegravir)
Indication and Usage: TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children aged 12 years and older and weighing at least 40 kg. The following should be considered prior to initiating TIVIC
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SOURCE ViiV Healthcare
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