s) 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
*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.
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-RNA at weeks 4 and 12 of INCIVEK combination treatment may benefit from an additional 36 weeks of peginterferon alfa and ribavirin (48 weeks total) [see Clinical Studies (14.2) ].
2.2 Dose Reduction
To prevent treatment failure, the dose of INCIVEK must not be reduced or interrupted. Refer to the respective prescribing information for dose modification of peginterferon alfa and ribavirin [see Warnings and Precautions (5.7) ].
2.3 Discontinuation of Dosing
Patients with inadequate viral response are unlikely to achieve SVR, and may develop treatment-emergent resistance substitutions [see Microbiology (12.4 )]. Discontinuation of therapy is recommended in all patients with (1) HCV-RNA levels of greater than or equal to 1000 IU/mL at Treatment Week 4 or 12; or (2) confirmed detectable HCV-RNA levels at Treatment Week 24 (see Table 2).
Table 2: Treatment Futility Rules: All Patients HCV-RNA Action
Week 4 or Week 12: Greater than 1000 IU/mL Discontinue INCIVEK and peginterferon alfa and ribavirin (INCIVEK treatment complete at 12 weeks)
Week 24: Detectable Discontinue peginterferon alfa and ribavirin
If peginterferon alfa or ribavirin is discontinued for any reason, INCIVEK must also be discontinued.
3 DOSAGE FORMS AND STRENGTHS
Each tablet contains 375 mg of telaprevir. Tablets are available as purple, film-coated, capsule-shaped tablets debossed with the characters "V 375" on one side.
4 CONTRAINDICATIONS
Contraindications to peginterferon alfa and ribavirin also apply to INCIVEK combination treatment.
INCIVEK combination treatment is contraindicated in:
•women who are or may become pregnant. Ribavirin may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug treatment, the patient should be apprised of the potential hazard to a fetus [see Warnings and Precautions (5.1), Use in Specific Populations (8.1), and Patient Counseling Information (17.1) ].
•men whose female partners are pregnant.
INCIVEK is contraindicated when combined with drugs that ar |
