Biotech Values

[DewDiligence]

...the Abbvie program [Viekira Pak] is not approved for DAA failures.

Actually, patients who failed a prior DAA regimen are not an exclusion in the V-Pak label:

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206619lbl.pdf

INDICATIONS AND USAGE

VIEKIRA PAK with or without ribavirin is indicated for the treatment of patients with genotype 1 chronic hepatitis C virus (HCV) infection including those with compensated cirrhosis.

Although ABBV did not include prior DAA failures in its phase-3 program, patients who fail to achieve a cure on Harvoni can certainly use Viekira Pak on-label in the second-line setting.

p.s. The fact that Harvoni does not contain a protease inhibitor eliminates the PI-resistance issue that makes V-Pak a less than ideal choice for patients who failed regimens containing Incivek or Victrelis.