FDA Approve Boceprevir (Victrelis) for HCV

On 13 May 2011, the FDA approved boceprevir (Victrelis) to be used in combination with peginterferon alfa and ribavirin to treat hepatitis C genotype 1. Boceprevir is the first direct acting antiviral DAA) against the hepatitis C virus to be approved.

Boceprevir is indicated in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.

The approval of boceprevir is based on safety and efficacy data in approximately 1500 adult subjects who were previously untreated (SPRINT-2) or who had failed previous peginterferon alfa and ribavirin therapy (RESPOND-2) in Phase 3 clinical studies.

Boceprevir must be administered in combination with peginterferon alfa and ribavirin. The dose of boceprevir is 800 mg (four 200-mg capsules) three times daily (every 7-9 hours) with food [a meal or light snack].

The following points should be considered when initiating boceprevir for treatment of chronic hepatitis C infection:

• Boceprevir must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
• Boceprevir efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes boceprevir or other HCV NS3/4A protease inhibitors.
• Boceprevir in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2-log₁₀ HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included subjects who were poorly interferon responsive. Subjects with less than 0.5-log₁₀ HCV-RNA decline in viral load at Treatment Week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than 2-log₁₀ viral load decline at Treatment Week 12) to peginterferon alfa and ribavirin therapy.
• Poorly interferon responsive patients who were treated with boceprevir 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.

Source: FDA listserve (13 May 2011).

For full prescribing details se the product lable at:

www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

www.accessdata.fda.gov/drugsatfda_docs/label/2011/202258lbl.pdf (PDF download)

Links to external websites are current at time of posting but not maintained.