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Telaprevir in Combination with Peginterferon Alfa-2a/Ribavirin in HCV/HIV Co-infected Patients: A 24-Week Treatment Interim Analysis
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Reported by Jules Levin
AASLD Nov 5-9 2011 SF
KE Sherman1*, JK Rockstroh2, DT Dieterich3, V Soriano4, P-M Girard5, S McCallister6, N Adda6, M Bsharat6, BS Adiwijaya6, L Mahnke6, MS Sulkowski7
1University of Cincinnati College of Medicine, Cincinnati, OH, United States; 2University of Bonn, Bonn, Germany; 3Mount Sinai School of Medicine, New York, NY, United States 4Hospital Carlos III, Madrid, Spain; 5Hôpital Saint Antoine, Paris, France; 6Vertex Pharmaceuticals Incorporated, Cambridge, MA, United States; 7Johns Hopkins University School of Medicine, Baltimore, MD, United States.
CONCLUSIONS
· In this interim analysis, higher Week 24 on-treatment responses were seen in chronic genotype 1 HCV/HIV co-infected patients treated with T/PR (71%) compared to PR alone (55%).
· TVR exposures were comparable across ART regimens.
· Overall safety and tolerability of patients treated with TVR combination treatment was comparable to that previously observed in chronic genotype 1 HCV monoinfected patients.
--Hyperbilirubinemia was noted in patients receiving T/PR with an ATV/r-based regimen and was primarily unconjugated.
References
1. INCIVEK [package insert]. Cambridge, MA: Vertex Pharmaceuticals Incorporated; 2011.
2. INCIVO [EU summary of product characteristics]. Beerse, Belgium: Tibotec; 2011.
3. INCIVEK [Canada product monograph]. Cambridge, MA: Vertex Pharmaceuticals Incorporated; 2011.
4. Jacobson IM, et al. N Engl J Med. 2011; 364(25):2405-16.
5. Sherman KE, et al. N Engl J Med. 2011; 365(11):1014-24. [Erratum: N Engl J Med. 2011;365:1551].
6. Zeuzem S, et al. N Engl J Med. 2011; 364(25):2417-28.
7. Van Heeswijk et al. CROI 2011; Abstract 146LB
8. Molina J-M, et al. The Lancet (2008) 372: 646-655
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