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news.Shionogi-ViiV Healthcare has released the phase III data required for initial regulatory filings of the investigational integrase inhibitor dolutegravir in adults infected with HIV.
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The phase III studies data include VIKING-3 and SAILING studies, which used dolutegravir in treatment of HIV patients who have already experienced treatment.
The two studies support the previously disclosed data from the SPRING-2 and SINGLE studies.
These additional study data are expected to support Shionogi-ViiV Healthcare’s plans to commence global regulatory submissions for dolutegravir before the end of 2012.
Dolutegravir has not received any approval as a drug to treat HIV or any other indication anywhere in the world.
VIKING-3, SAILING, SPRING-2 and SINGLE are all ongoing clinical studies in treatment-experienced adults with HIV-1 to assess the antiviral activity and safety of dolutegravir 50mg twice-daily in treatment-experienced adults with HIV-1.