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responders, and relapsers. Telaprevir must not be used as
monotherapy.
Presentation: 375 mg film-coated tablet, oral administration.
Dosage and administration: 750 mg taken 3 times a day (7-9
hours apart) with food. Telaprevir must be administered with
both PegIFN alfa and RBV for all patients for 12 weeks,
followed by a response-guided regimen of either 12 or 36
additional weeks of PegIFN/RBV, depending on viral response
and prior response status.
Side effects: Rash, pruritus, anemia, nausea, hemorrhoids,
diarrhea, anorectal discomfort, dysgeusia, fatigue, vomiting.
Serious skin reactions, including Drug Rash with Eosinophilia
and Systemic Symptoms (DRESS) and Stevens-Johnson syndrome
were reported in less than 1% of subjects. If a serious skin
reaction occurs, all components of telaprevir combination
treatment must be discontinued immediately. The addition of
telaprevir to PegIFN/RBV is associated with an additional
decrease in hemoglobin concentrations. All contraindications to
PegIFN alfa and RBV also apply, since telaprevir must be
administered only in triple therapy.
References
Hezode C, Forestier N, Dusheiko G, et al. Telaprevir and peginterferon with or
without ribavirin for chronic HCV infection. N Engl J Med 2009;360:1839-50
McHutchison JG, Manns MP, Muir A, et al. Telaprevir for previously treated
chronic HCV infection. N Engl J Med 2010;362:1292-303.
Zeuzem S , Andreone P, Pol S, Lawitz E, et al. Telaprevir for retreatment of HCV
infection. N Engl J Med 2011;364:2417-28.
Internet sources
Incivek: www.incivek.com
FDA, Prescribing Information (PDF, 23 pages): goo.gl/k2VMV
Vertex Pharmaceuticals: www.vrtx.com