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):
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.