Biotech Values

[DewDiligence]

ABBV/ENTA—HIV co-infection part is recommended, while cirrhosis is strongly suggested, see the wording difference there, thus ABBV/ENTA to include cirrhosis in original NDA, but not HIV co-infection.

The staging of TURQUOISE-1 and TURQUOISE-2 was more of a business decision than a regulatory decision, IMO.

It’s very important for ABBV/ENTA to have GT1 cirrhotic patients on-label from the get-go, while promoting the GT1 regimen for HCV/HIV co-infected patients can wait. The initial label will not explicitly exclude HIV patients, but rather will say that the drug cocktail has not (yet) been tested in HIV patients.