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Telaprevir Indications/Usage: from the FDA Product Label - pdf of Label attached
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Download the PDF here
INDICATIONS AND USAGE
INCIVEK is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated, in combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic hepatitis C (CHC) in adult patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have been previously treated with interferon-based treatment, including prior null responders, partial responders, and relapsers. (1)
· INCIVEK must not be used as monotherapy and must only be used in combination with peginterferon alfa and ribavirin. (5.7)
· A high proportion of previous null responders (particularly those with cirrhosis) did not achieve Sustained Virologic Response (SVR) and had telaprevir resistance-associated substitutions emerge on treatment with INCIVEK. (12.4, 14.3)
· INCIVEK efficacy has not been established for patients who have previously failed therapy with a treatment regimen that includes INCIVEK or other HCV NS3/4A protease inhibitors. (12.4)
DOSAGE AND ADMINISTRATION
· 750 mg taken 3 times a day (7-9 hours apart) with food (not low fat). (2,12.3, 17.4)
· INCIVEK must be administered with both peginterferon alfa and ribavirin for all patients for 12 weeks, followed by a response-guided regimen of either 12 or 36 additional weeks of peginterferon alfa and ribavirin depending on viral response and prior response status. (2)
· For specific dosage instructions for peginterferon alfa and ribavirin, refer to their respective prescribing information. (2)
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