Biotech Values

[DewDiligence]

GILD—Musings on POLARIS studies of 3-DAA HCV regimen:

All told, the results reported today for SOF/VEL/VOX are nothing special, IMO. POLARIS-2—the main SOF/VEL/VOX trial in treatment-naïve patients—actually failed its primary endpoint of showing non-inferiority to Epclusa (SOF/VEL 2-DAA):

http://finance.yahoo.com/news/gilead-announces-svr12-rates-four-140700027.html

The POLARIS-2 study did not meet its primary endpoint; with a pre-specified 5 percent margin, the SVR12 rate for patients receiving treatment with SOF/VEL/VOX for eight weeks was not statistically non-inferior to the SVR12 rate for patients receiving SOF/VEL for 12 weeks.

The SOF/VEL/VOX arm in POLARIS-2 not only failed fail to achieve statsig non-inferiority to the Epclusa arm, but also was numerically worse than the Epclusa arm on SVR12 (95% vs 98%).

Although an 8-week regimen of SOF/VEL/VOX worked as well as Epclusa in the (smaller) POLARIS-3 trial for treatment-naïve cirrhotic patients, the POLARIS-2 results call into question whether 8 weeks is an appropriate duration for SOF/VEL/VOX in treatment-naïve patients.