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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

weighing <40 kg, or in INSTI-experienced paediatric patients with documented or clinically suspected INSTI resistance.

Please visit the following link for the full U.S. prescribing and patient information: https://www.viivhealthcare.com/media/58599/us_tivicay.pdf

About FLAMINGO (ING114915)
FLAMINGO is an ongoing phase IIIb/IV, randomised, multi-centre, multinational, open-label non-inferiority (-12% margin) study with a pre-specified test for superiority, designed to compare the efficacy and safety of dolutegravir to darunavir regimens in HIV-1 infected, treatment-naive patients. The primary objective for FLAMINGO is to demonstrate the antiviral activity of a dolutegravir regimen compared to a darunavir regimen over 48 weeks. As per study design, trial participants will continue on therapy in order to assess the tolerability, long-term safety, and antiviral and immunologic activity of dolutegravir vs darunavir over 96 weeks. Investigators will also evaluate viral resistance in patients experiencing virologic failure.

About Tivicay® (dolutegravir)
Tivicay is an integrase inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 in adults and children aged 12 years and older weighing at least 40 kg. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.

It is available as a small, yellow, 50mg tablet. Importantly, it can be taken with or without food and at any time of the day.

ViiV Healthcare announced submission of a Marketing Authorisation Application (MAA) for dolutegravir to the European Medicines Agency (EMA) on 17 December 2012. Regulatory applications are also being evaluated i
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SOURCE ViiV Healthcare
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