NT*
(HCV-RNA Results†) RECOMMENDATION
At Treatment Week 8 At Treatment Week 24
Previously Untreated Patients Undetectable Undetectable Complete three-medicine regimen at TW28.
Detectable Undetectable 1.Continue all three medicines and finish through TW36; and then
2.Administer peginterferon alfa and ribavirin and finish through TW48.
Previous Partial Responders or Relapsers Undetectable Undetectable Complete three-medicine regimen at TW36.
Detectable Undetectable 1.Continue all three medicines and finish through TW36; and then
2.Administer peginterferon alfa and ribavirin and finish through TW48.
* TREATMENT FUTILITY
If the patient has HCV-RNA results greater than or equal to 100 IU/mL at TW12, then discontinue three-medicine regimen.
If the patient has confirmed, detectable HCV-RNA at TW24, then discontinue three-medicine regimen.
†In clinical trials, HCV-RNA in plasma was measured using a Roche COBAS® TaqMan® assay with a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. See Warnings and Precautions (5.5) for a description of HCV-RNA assay recommendations.
Response-Guided Therapy was not studied in subjects who had less than a 2-log10 HCV-RNA decline by treatment week 12 during prior therapy with peginterferon alfa and ribavirin. If considered for treatment, these subjects should receive 4 weeks of peginterferon alfa and ribavirin followed by 44 weeks of VICTRELIS 800 mg orally three times daily (every 7–9 hours) in combination with peginterferon alfa and ribavirin. In addition, consideration should be given to treating previously untreated patients who are poorly interferon responsive (as determined at TW 4) with 4 weeks peginterferon alfa and ribavirin followed by 44 weeks of VICTRELIS 800 mg orally three times daily (every 7–9 hours) in combination with peginterferon alfa and ribavirin in order to maximize rates of SVR [see Clinical Studies (14)].
2.2 VICTRELIS Combination Therapy: Patients with Cirrhosis
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 7–9 hours) in combination with peginterferon alfa and ribavirin.
2.3 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 peginterferon alfa and ribavirin Package Inserts 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.
2.4 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 100 IU/mL at TW 12; or 2) confirmed detectable HCV-RNA levels at TW24.
3 DOSAGE FORMS AND STRENGTHS
VICTRELIS 200 mg Capsules, red-colored cap with the Merck logo printed in yellow ink, and a yellow-colored body with "314" printed in red ink.
4 CONTRAINDICATIONS
Contraindications to peginterferon alfa and ribavirin also apply to VICTRELIS combination treatment.
VICTRELIS combination treatment is contraindicated in:
•Pregnant wom |
