Drug Detail:Victrelis (Boceprevir [ boe-sep-re-vir ])
Generic Name: BOCEPREVIR 200mg
Dosage Form: capsule
Drug Class: Protease inhibitors
VICTRELIS must be administered in combination with peginterferon alfa and ribavirin. The dose of VICTRELIS is 800 mg (four 200-mg capsules) three times daily (every 7 to 9 hours) with food [a meal or light snack] (see Table 1). Refer to the prescribing information for peginterferon alfa and ribavirin for instructions on dosing.
The following dosing recommendations differ for some subgroups from the dosing studied in the Phase 3 trials [see Clinical Studies (14)]. Response-Guided Therapy (RGT) is recommended for most individuals, but longer dosing is recommended in targeted subgroups (e.g., patients with cirrhosis).
VICTRELIS/Peginterferon alfa/Ribavirin Combination Therapy: Patients Without Cirrhosis Who Are Previously Untreated or Who Previously Failed Interferon and Ribavirin Therapy
- Initiate therapy with peginterferon alfa and ribavirin for 4 weeks (Treatment Weeks 1–4).
- Add VICTRELIS 800 mg (four 200-mg capsules) orally three times daily (every 7 to 9 hours) to peginterferon alfa and ribavirin regimen after 4 weeks of treatment. Based on the patient's HCV-RNA levels at Treatment Week (TW) 8, TW12 and TW24, use the following guidelines to determine duration of treatment (see Table 1).
| ASSESSMENT* (HCV-RNA Results†) |
RECOMMENDATION | ||
|---|---|---|---|
| At Treatment Week 8 | At Treatment Week 24 | ||
|
|||
| Previously Untreated Patients | Not Detected | Not Detected | Complete three-medicine regimen at TW28. |
| Detected | Not Detected |
|
|
| Previous Partial Responders or Relapsers‡ | Not Detected | Not Detected | Complete three-medicine regimen at TW36. |
| Detected | Not Detected |
|
|
| Previous Null Responders‡ | Detected or Not Detected | Not Detected | Continue all three medicines and finish through TW48. |
Consideration should be given to treating previously untreated patients who are poorly interferon responsive (as determined at TW4) with 4 weeks peginterferon alfa and ribavirin followed by 44 weeks of VICTRELIS 800 mg orally three times daily (every 7 to 9 hours) in combination with peginterferon alfa and ribavirin in order to maximize rates of SVR.
VICTRELIS/Peginterferon alfa/Ribavirin Combination Therapy: Patients with Cirrhosis
Prior to initiating therapy in patients with compensated cirrhosis, see Use in Specific Populations (8.7) for additional information.
Patients with compensated cirrhosis should receive 4 weeks peginterferon alfa and ribavirin followed by 44 weeks VICTRELIS 800 mg (four 200-mg capsules) three times daily (every 7 to 9 hours) in combination with peginterferon alfa and ribavirin.
Dose Modification
Dose reduction of VICTRELIS is not recommended.
If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. Refer to the prescribing information for peginterferon alfa and ribavirin for additional information about how to reduce and/or discontinue the peginterferon alfa and/or ribavirin dose. VICTRELIS must not be administered in the absence of peginterferon alfa and ribavirin. If peginterferon alfa or ribavirin is permanently discontinued, VICTRELIS must also be discontinued.
Discontinuation of Dosing Based on Treatment Futility
Discontinuation of therapy is recommended in all patients with 1) HCV-RNA levels of greater than or equal to 1000 IU per mL at TW8; or 2) HCV-RNA levels of greater than or equal to 100 IU per mL at TW12; or 3) confirmed detectable HCV-RNA levels at TW24.
