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DewDiligence

07/21/14 8:48 AM

#180514 RE: linhdtu #180509

ABBV/ENTA have a phase-3 trial called TURQUOISE-1* where 100% of the patients are HIV/HCV co-infected:

http://clinicaltrials.gov/ct2/show/NCT01939197

This trial is has an expected completion date of Sep 2015, and hence TURQUOISE-1 data will be used for a supplementary NDA/MAA to add HIV/HCV co-infection to the label. In the meantime, there will likely be some off-label use of ABBV/ENTA’s 3-DAA regimen for co-infected patients.

*Not to be confused with TURQUOISE-2, the already-completed trial in cirrhotic patients (#msg-96696670).