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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1Chronic Hepatitis C
INCIVEK™ (telaprevir), in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have previously been treated with interferon-based treatment, including prior null responders, partial responders, and relapsers [see Clinical Studies (14.2 and 14.3), including definitions of these terms].
The following points should be considered when initiating treatment with INCIVEK:
INCIVEK must not be administered as monotherapy and must only be prescribed with both peginterferon alfa and ribavirin [see Warnings and Precautions (5.7)].
A high proportion of previous null responders (particularly those with cirrhosis) did not achieve a Sustained Virologic Response (SVR) and had telaprevir resistance-associated substitutions emerge on treatment with INCIVEK combination treatment [see Microbiology (12.4) and Clinical Studies (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 [see Microbiology (12.4)].
2 DOSAGE AND ADMINISTRATION
2.1INCIVEK/Peginterferon Alfa/Ribavirin Combination Treatment
The recommended dose of INCIVEK tablets is 750 mg (two 375-mg tablets) taken orally 3 times a day (7-9 hours apart) with food (not low fat) [see Clinical Pharmacology (12.3) and Patient Counseling Information (17.4)].
For specific dosage instructions for peginterferon alfa and ribavirin, refer to their respective prescribing information.
Duration of Treatment
The recommended duration of treatment with INCIVEK is 12 weeks in combination with peginterferon alfa and ribavirin. HCV-RNA levels should be monitored at weeks 4 and 12 to determine combination treatment duration and assess for treatment futility (Tables 1 and 2).
Table 1: Recommended Treatment Duration (See also Table 2 for Treatment Futility Rules) *
In clinical trials, HCV-RNA in plasma was measured using a COBAS® TaqMan® assay with a lower limit of quantification of 25 IU/mL and a limit of detection of 10 IU/mL. See Laboratory Tests (5.6) for a description of HCV-RNA assay recommendations.
Treatment-Naïve and Prior Relapse Patients
HCV-RNA* Triple Therapy
INCIVEK,
peginterferon alfa and ribavirin Dual Therapy
peginterferon alfa and ribavirin Total Treatment Duration
Undetectable at Weeks 4 and 12 First 12 weeks Additional 12 weeks 24 weeks
Detectable (1000 IU/mL or less) at Weeks 4 and/or 12 First 12 weeks Additional 36 weeks 48 weeks
Prior Partial and Null Responder Patients
Triple Therapy
INCIVEK,
peginterferon alfa and ribavirin Dual Therapy
peginterferon alfa and ribavirin Total Treatment Duration
All Patients First 12 weeks Additional 36 weeks 48 weeks
For the purpose of assessing response-guided therapy eligibility at weeks 4 and 12 (see Table 1), an "undetectable" HCV-RNA result is required; a confirmed "detectable but below limit of quantification" HCV-RNA result should not be considered equivalent to an "undetectable" HCV-RNA result [see Laboratory Tests (5.6)].
Treatment-naïve patients with cirrhosis who have undetectable HCV-R
