FDA update to Victrelis (boceprevir) label to include a new virologic futility rule

On February 24, 2014, FDA approved an update to the Victrelis (boceprevir) label to include a new virologic futility rule.

Specifically Section 2, Dosage and Administration, Table 1 was revised to state:
If a patient has HCV-RNA results greater than or equal to 1000 IU/mL at treatment week 8, then discontinue three-medicine regimen.

This statement is also reflected in subsection 2.4
Discontinuation of Dosing Based on Treatment Futility:
Discontinuation of therapy is recommended in all patients with 1) HCV-RNA levels of greater than or equal to 1000 IU per mL at TW8 (treatment week 8); or 2) HCV-RNA levels of greater than or equal to 100 IU per mL at TW12 (treatment week 12); or 3) confirmed detectable HCV-RNA levels at TW24 (treatment week 24).

You can view the complete revised Victrelis label and Medication Guide at Drugs@FDA.

Richard Klein  Office of Special Health Issues 
Food and Drug Administration  Kimberly Struble 
Division of Antiviral Drug Products  Food and Drug Administration