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:
Source: FDA listserve (13 May 2011).
For full prescribing details se the product lable at:
Links to external websites are current at time of posting but not maintained.
This article was provided by HIV i-Base. It is a part of the publication HIV Treatment Bulletin. Visit HIV i-Base's website to find out more about their activities, publications and services.
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