VICTRELIS (boceprevir)

VICTRELIS (boceprevir)

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
• Should not be used in null responders to prior therapy (less than 2 log drop HCV-RNA) during 12 weeks of therapy with peginterferon alfa and ribavirin

This Medication is Not Approvable for the following condition(s):

• Treatment of Null responders
• Any condition not listed above as an approved indication

Dosing:

• VICTRELIS must be administered in combination with peginterferon alfa and ribavirin. Therapy is initiated with peginterferon alfa and ribavirin for 4 weeks
• Beginning in treatment week five, VICTRELIS is added at a dose of 800 mg (four 200 mg capsules) orally three times daily (every seven-nine hours) with food (a meal or light snack)
• Based on the patient's virus (HCV-RNA) levels at treatment weeks 8, 12 and 24, dosing is adjusted using the following response-guided therapy guidelines

Treatment-naive patients

• Patients who are undetectable at treatment weeks eight and 24 complete all therapy at treatment week 28
• Patients who are detectable at treatment week eight, but undetectable at treatment week 24, complete VICTRELIS at treatment week 36 and continue on peginterferon alfa and ribavirin alone until treatment week 48

Treatment-failure patients

• Patients (previous partial responders or relapsers) who are undetectable at treatment weeks eight and 24 complete all therapy at treatment week 36.
• Patients who are detectable at treatment week 8, but undetectable at treatment week 24, complete VICTRELIS at treatment week 36 and continue on peginterferon alfa and ribavirin alone until treatment week 48

Treatment-failure patients who had less than a two log decrease in virus (HCV-RNA) at treatment week 12 of prior treatment (null responders)

• Response-guided therapy was not studied in treatment-failure patients who had less than a two log decrease in virus (HCV-RNA) at treatment week 12 of prior treatment (null responders). If treated, these patients should receive four weeks of peginterferon alfa and ribavirin followed by 44 weeks of VICTRELIS in combination with peginterferon alfa and ribavirin

Patients with compensated cirrhosis

• should receive 4 weeks peginterferon alfa and ribavirin followed by 44 weeks of VICTRELIS in combination with peginterferon alfa and ribavirin

Patients who have HCV-RNA results greater than or equal to 100 IU/mL

• At treatment week 12 discontinue the three-medicine regimen

Patients who have confirmed detectable HCV-RNA

• At treatment week 24 discontinue the three-medicine regimen

Response-guided therapy (RGT)

• Patients with undetectable virus (HCV-RNA) at treatment week 8 were considered early responders and were eligible for a shorter duration of therapy
• Treatment-naïve patients with undetectable HCV-RNA during weeks 8 through 24 were eligible to stop all treatment at week 28
• Treatment-failure patients with undetectable HCV-RNA at treatment weeks 8 and 12 were eligible to stop all treatment at week 36