Biotech Values

[DewDiligence]

ABBV/ENTA—G/P regimen produces 98% SVR in CKD patients with any HCV genotype treated for 12 weeks:

http://ir.enanta.com/phoenix.zhtml?c=147990&p=irol-newsArticle&ID=2222520

Enanta Pharmaceuticals…today announced 98 percent (n=102/104) of chronic hepatitis C virus (HCV) infected patients with severe chronic kidney disease (CKD) achieved sustained virologic response following 12 weeks of treatment (SVR12) with AbbVie’s investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in the primary intent-to-treat (ITT) analysis. In a modified intent-to-treat (mITT) analysis, SVR12 was achieved in 100 percent (n=102/102) of severe CKD patients. The mITT analysis excludes patients who did not achieve SVR for reasons other than virologic failure.

…The EXPEDITION-4 study enrolled 104 patients with severe chronic kidney disease, including 85 patients (82 percent) who were receiving dialysis at enrollment and 20 patients (19 percent) who had compensated cirrhosis.

The study also included those who were not cured with previous treatment with sofosbuvir (SOF) plus ribavirin (RBV) or with interferon (IFN) plus RBV, with or without SOF (44 patients, 42 percent).

The above data are stellar, of course.

EXPEDITION-4 is one of ten phase-3 trials for Glecaprevir/Pibrentasvir; please see #msg-122031014 for details.