INCIVEK (telaprevir)

INCIVEK (telaprevir)

ORAL ADMINISTRATION

Indications for Prior Authorization:

• Treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy

All of the following must be met as a condition for coverage:

• Must not be used as monotherapy

This medication is not approvable for the following condition(s):

• Boceprevir (Victrelis) is WHA preferred agent except for null responders
• Any condition not listed above as an approved indication

Dosing:

• Telaprevir 750 mg taken three times a day (seven-nine hours apart) with food (not low fat) for 12 weeks. Telaprevir must be administered with both peginterferon alfa and
• ribavirin for all patients for 12 weeks (triple therapy)
• After 12 weeks dual therapy is initiated based on a response-guided regimen of either 12 or 36 additional weeks of peginterferon alfa (PEG) and ribavirin (RIB) depending on viral response
  • HCV-RNA undetectable at week four and 12 continue therapy with PEG and RIB for a total of 24 weeks
  • HCV-RNA > 1000 IU/ml at week four and/or week 12 continue therapy with PEG and RIB for a total of 48 weeks
• 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 four and 12 to determine combination treatment duration and assess for treatment futility
• Patients with inadequate viral response are unlikely to achieve SVR, and may develop treatment-emergent resistance substitutions
• Discontinuation of therapy is recommended in all patients with
  • HCV-RNA levels of greater than or equal to 1000 IU/mL at Treatment Week 4 or 12
  • Confirmed detectable HCV-RNA levels at Treatment Week 24