Biotech Values

[DewDiligence]

Re: ABBV/ENTA next-gen HCV regimen

A phase-3 trial of ABT-493/ABT-530 in non-cirrhotic GT1 patients, called ENDURANCE-1, is now listed on clinicaltrials.gov:

https://clinicaltrials.gov/ct2/show/NCT02604017

Comments:

• There are two arms: one for 12 weeks and one for 8 weeks.

• Only one dose of ABT-493 and ABT-530 is being tested, but the dose size is not (yet) listed. Both drugs are given once daily.

• ABT-493 and ABT-530 are the only drugs in the regimen. (No ribavirin and no PI booster.)

• The enrollment target is 600 patients (300 per arm); 60 trial sites (including US and ex-US) are already listed.

• Expected completion (for SVR12 reporting) is Jan 2017.