sábado, 16 de febrero de 2013

FDA Hepatitis Update - Victrelis (boceprevi​r) label updates

On February 13, 2013, FDA approved changes to the Victrelis (boceprevir) label to expand the indication to include the treatment of prior null responders. Below are the major changes to the labeling.
In Section 2, Dosage and Administration: The duration of therapy in previous null responders (patients who who achieve little or no decrease in hepatitis C viral load during treatment) is to continue Victrelis, peginterferon alfa and ribavirin through Week 48 if the HV RNA is detected or not detected at Week 8 and not detected at Week 24.
In Section 5, Warning and Precaution, and section 6, Adverse Reactions, text was added to emphasize that if ribavirin and/or peginterferon are permanently discontinued the entire regimen must also be discontinued.

In Section 14, Clinical Studies, the following trial results were added:

Prior Null Responders to Interferon and Ribavirin Therapy
PROVIDE is an ongoing, open-label, single-arm study of VICTRELIS 800 mg orally three times daily in combination with peginterferon alfa-2b 1.5 micrograms per kg per week subcutaneously and weight-based ribavirin (600 - 1,400 mg per day orally divided twice daily) in adult subjects with chronic hepatitis C (HCV) genotype 1 infection who did not achieve SVR (Sustained Virological Response) while in the peginterferon alfa/ribavirin control arms of previous Phase 2 and 3 studies of combination therapy with VICTRELIS. Subjects who enrolled in PROVIDE within 2 weeks after the last dose of peginterferon alfa/ribavirin in the parent study received VICTRELIS 800 mg three times daily + peginterferon alfa-2b + ribavirin for 44 weeks. Subjects who were not able to enroll in this study within 2 weeks received PegIntron/REBETOL lead-in for 4 weeks followed by VICTRELIS 800 mg three times daily + peginterferon alfa-2b + ribavirin for 44 weeks.

Among the subjects who were null responders in the peginterferon alfa/ribavirin control arm of the parent study that received the 4-week PegIntron/REBETOL lead-in treatment followed by VICTRELIS 800 mg three times daily + PegIntron/REBETOL for 44 weeks, 38% (20/52) achieved SVR, and the relapse rate was 14% (3/22).
The complete revised label can be viewed at Drugs@FDA.
Victrelis is a product of Merck.
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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