Incivek Dosage
Generic name: telaprevir 375mg
Dosage form: tablet, film coated
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INCIVEK/Peginterferon Alfa/Ribavirin Combination Treatment
The recommended dose of INCIVEK tablets is 1125 mg (three 375-mg tablets) taken orally twice daily (10-14 hours apart) with food (not low fat) [see Clinical Pharmacology (12.3)].
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).
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| Treatment-Naïve and Prior Relapse Patients | |||
| Triple Therapy | Dual Therapy | Total Treatment Duration | |
| HCV RNA* | INCIVEK, peginterferon alfa and ribavirin |
peginterferon alfa and ribavirin | |
| Undetectable (Target Not Detected) 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 | Dual Therapy | Total Treatment Duration | |
| INCIVEK, peginterferon alfa and ribavirin |
peginterferon alfa and ribavirin | ||
| 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 (Target Not Detected) result is required; a confirmed "detectable but below limit of quantification" HCV RNA result should not be considered equivalent to an "undetectable" HCV RNA (Target Not Detected) result [see Laboratory Tests (5.5)].
Treatment-naïve patients with cirrhosis who have undetectable HCV RNA (Target Not Detected) 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)].
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 (5.6)].
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 1000 IU/mL at Treatment Week 4 or 12; or (2) confirmed detectable HCV RNA levels at Treatment Week 24 (see Table 2).
| 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.
