Page 107 - The Flying Publisher Guide to Hepatitis C Treatment

Appendix – Selected drug profiles | 107

Victrelis™ (Boceprevir)
Manufacturer: Schering Corporation/Merck & co., Inc.
Indications: Boceprevir is a NS3/4A protease inhibitor indicated
for the treatment of CHC genotype 1 infection, in combination
with PegIFN/RBV, in adult patients (≥18 years of age) with
compensated liver disease, including cirrhosis, who are
previously untreated or who have failed previous IFN and RBV
therapy. Boceprevir in combination with PegIFN/RBV has not
been studied in patients documented to be historical null
responders (less than a 2 log 10 HCV RNA decline by treatment
week 12) during prior therapy with PegIFN/RBV. Boceprevir
must not be used as a monotherapy.
Presentation: Capsules 200 mg.
Dosage: 800 mg three times daily (every 7-9 hours). Therapy is
initiated with PegIFN/RBV for 4 weeks. Boceprevir is added to
PegIFN/RBV regimen after 4 weeks of treatment. Based on the
patient’s HCV RNA levels at treatment weeks 8, 12 and 24,
response-guided therapy may be used to determine duration of
treatment.
Side effects: The most commonly reported adverse reactions
(greater than 35% of subjects) in clinical trials were fatigue,
anemia (the addition of Boceprevir to PegIFN/RBV is associated
with an additional decrease in hemoglobin concentrations),
nausea, headache and dysgeusia (alteration of taste). All
contraindications to PegIFN alfa and RBV also apply since
Boceprevir must be administered only in triple therapy.
References
Schiff E, Poordad F, Jacobson I, et al. Boceprevir combination therapy in null
responders: response dependent on interferon responsiveness. J Hepatol
2008;48:S46.
Bacon BR., Gordon SC, Lawitz E, et al. Boceprevir for Previously Treated Chronic
HCV Genotype 1 Infection. N Engl J Med 2011;364:1207-17.