"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is updating labeling information for the hepatitis C antivirals ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) and sofosbuvir (Sovaldi, Gilead Sciences) after th"...
VICTRELIS® (boceprevir) is indicated for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy, including prior null responders, partial responders, and relapsers [see Clinical Studies].
The following points should be considered when initiating VICTRELIS for treatment of chronic hepatitis C infection:
- VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
- The efficacy of VICTRELIS has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
- Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin [see Microbiology and Clinical Studies].
DOSAGE AND ADMINISTRATION
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]. 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).
Table 1 : Duration of Therapy in Patients Without
Cirrhosis Who Are Previously Untreated or Who Previously Failed Interferon and
|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.|
|Previous Partial Responders or Relapsers‡||Not Detected||Not Detected||Complete three-medicine regimen at TW36.|
|Previous Null Responders‡||Detected or Not Detected||Not Detected||Continue all three medicines and finish through TW48.|
If the patient has HCV-RNA results greater than or equal to 1000 IU/mL at TW8, then discontinue three-medicine regimen.
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.
†“Not Detected” refers to HCV-RNA assay results reported as “Target Not Detected” or “HCV-RNA Not Detected”. 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 for a description of HCV-RNA assay recommendations.
‡ See Clinical Studies for definitions of previous response to interferon and ribavirin therapy.
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 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 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.
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.
VICTRELIS 200 mg capsules are comprised of a red-colored cap with the Merck logo printed in yellow ink, and a yellow-colored body with “314” printed in red ink. The capsules are packaged into a carton with 28 bottles containing 12 capsules (NDC 0085-0314-02).
Storage And Handling
VICTRELIS Capsules should be refrigerated at 2-8°C (36-46°F) until dispensed. Avoid exposure to excessive heat. For patient use, refrigerated capsules of VICTRELIS can remain stable until the expiration date printed on the label. VICTRELIS can also be stored at room temperature up to 25°C (77°F) for 3 months. Keep container tightly closed.
Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., W hitehouse Station, NJ 08889, USA. Manufactured by: MSD International GmbH (Singapore Branch) Singapore 638414, Singapore. Revised: 07/2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/11/2014
Additional Victrelis Information
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