Boceprevir indications and usage
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Indications And Usage
VICTRELIS® (boceprevir) is indicated for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy, including prior null responders, partial responders, and relapsers [see Clinical Studies (14)].
The following points should be considered when initiating VICTRELIS for treatment of chronic hepatitis C infection:
- VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
- The efficacy of VICTRELIS has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
- Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin [see Microbiology (12.4) and Clinical Studies (14)].[1]
References
- ↑ "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s001lbl.pdf" (PDF). External link in
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Adapted from the FDA Package Insert.