February 25, 2014

FDA Hepatitis Update - Changes to the Victrelis (boceprevir) label

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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

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