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Victrelis (boceprevir)

Company: Merck
Approval Status: Approved May 2011
Treatment for: chronic hepatitis C genotype 1
Areas: Gastrointestinal; Immune System

| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |


General Information

Victrelis (boceprevir) is an inhibitor of the hepatitis C virus non-structural protein 3 (NS3) serine protease.

Victrelis is specifically indicated in combination with peginterferon alfa and ribavirin for adults with chronic hepatitis C genotype 1 infection with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.

Victrelis is supplied as a capsule for oral administration. The recommended dose of Victrelis is 800 mg (four 200-mg capsules) three times daily (every 7-9 hours) with food. Refer to the peginterferon alfa and ribavirin package inserts for instructions on dosing.


Clinical Results

FDA Approval
The FDA approval of Victrelis was based on two trials in 1500 adults who were previously untreated (SPRINT-2) or who had failed previous peginterferon alfa and ribavirin therapy (RESPOND-2).
SPRINT-2
This randomized, double-blind, placebo-controlled study enrolled subjects in two separate cohorts, one with non-African-American patients and the other with African-American patients. The trial evaluated 28- and 48-week regimens of boceprevir (800 mg three times daily (TID) in combination with PEGINTRON (1.5 mcg/kg/week) and REBETOL (600-1400 mg/day) compared to a control of PEGINTRON and REBETOL alone for 48 weeks. In the 28-week treatment arm, rapid viral response (RVR), defined as undetectable virus at 4 weeks of boceprevir treatment, (treatment week 8) was used to determine which boceprevir patients stopped all treatment at 28 weeks. The subjects who did not have RVR stopped boceprevir treatment at week 28 and continued PEGINTRON and REBETOL alone for an additional 20 weeks, for a total treatment duration of 48 weeks. In the 48-week treatment arm subjects received PEGINTRON and REBETOL plus boceprevir for a total treatment duration of 48 weeks. The subjects in any arm of the study with detectable virus at week 24 were considered treatment failures and treatment was discontinued. The primary endpoint was sustained virologic response (SVR). In the overall study population, 66% of subjects in the boceprevir 48-week treatment group and 63% of subejcts in the response-guided therapy group achieved SVR, compared to 38% of the control group (p<0.0001 for both, intent-to-treat analysis). Among the non-African-American patients in the boceprevir 48-week treatment group, 69% achieved SVR, and in the response-guided therapy group, 67% achieved SVR, compared to 40% in the control group (p<0.0001 for both, intent-to-treat analysis). Among the African-American patients, 53% of patients in the 48-week treatment group and 42% of patients in the response-guided therapy group achieved SVR, compared to 23% in the control group (p=0.004 and p=0.044, respectively, intent-to-treat analysis).
RESPOND-2
This randomized, double-blind, placebo-controlled study enrolled subjects who were either non-responders or relapsers to prior HCV therapy. The subjects received 36- and 48-week regimens of boceprevir (800 mg three times daily (TID) in combination with PEGINTRON (1.5 mcg/kg/week) and REBETOL (600-1400 mg/day) compared to a control of PEGINTRON and REBETOL alone for 48 weeks. In the 36-week treatment arm RVR criteria at 4 weeks of boceprevir treatment (treatment week 8) was used to determine which boceprevir patients were allowed to stop all treatment at 36 weeks. The subjects who did not meet the RVR criteria stopped boceprevir treatment at week 36 and continued on PEGINTRON and REBETOL alone for an additional 12 weeks, for a total treatment duration of 48 weeks. In the 48-week treatment arm subjects received PEGINTRON and REBETOL plus boceprevir for a total treatment duration of 48 weeks. Those subjects in any arm of the study with detectable virus at week 12 were considered treatment failures and discontinued treatment. The primary endpoint was sustained viral response (SVR). In the boceprevir 48-week treatment group, 66% of patients achieved SVR, and in the boceprevir response-guided therapy group, 59% of patients achieved SVR, compared to 21% of the control group (p<0.0001 for both, intent-to-treat analysis).


Side Effects

Adverse events associated with the use of Victrelis may include, but are not limited to, the following:

  • fatigue
  • anemia
  • nausea
  • headache
  • dysgeusia


Mechanism of Action

Victrelis (boceprevir) is an inhibitor of the hepatitis C virus non-structural protein 3 (NS3) serine protease.


Literature References

Bacon BR, Gordon SC, Lawitz E, Marcellin P, Vierling JM, Zeuzem S, Poordad F, Goodman ZD, Sings HL, Boparai N, Burroughs M, Brass CA, Albrecht JK, Esteban R; HCV RESPOND-2 Investigators Boceprevir for previously treated chronic HCV genotype 1 infection. New England Journal of Medicine 2011 Mar 31;364(13):1207-17

Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, Jacobson IM, Reddy KR, Goodman ZD, Boparai N, DiNubile MJ, Sniukiene V, Brass CA, Albrecht JK, Bronowicki JP; SPRINT-2 Investigators Boceprevir for untreated chronic HCV genotype 1 infection. New England Journal of Medicine 2011 Mar 31;364(13):1195-206


Additional Information

For additional information regarding Victrelis or hepatitis C, please visit the Victrelis web page.




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Victrelis Drug Information

The Victrelis drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.





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