BACKGROUND & AIMS: Protease inhibitor triple therapy for hepatitis C virus (HCV) infection (boceprevir or telaprevir with pegylated interferon and ribavirin) has been shown to increase rates of sustained virologic response in phase 3 trials. We investigated the proportion of patients who began therapy with this regimen in the 12 months after the Food and Drug Administration approval of boceprevir and telaprevir in the United States. METHODS: We performed a retrospective cross-sectional study of 487 patients with HCV genotype 1 infection (396 did not receive triple therapy, and 91 had begun triple therapy with boceprevir or telaprevir), who were seen at hepatology practices in Dallas and Miami from June 2011 through February 2012. The subjects were predominantly middle-aged, non-Hispanic white, and privately insured; 50% were treatment-naive, and most had advanced fibrosis. We compared features of patients who initiated triple therapy with those who deferred it. Treated patients were followed to determine the discontinuation rate in the first 12 weeks of treatment. RESULTS: Of patients assessed, only 18.7% began triple therapy, the same percentage as those receiving dual therapy (pegylated interferon and ribavirin) before boceprevir or telaprevir was approved for treatment of HCV infection in the United States. Reasons for deferring treatment included relative contraindications (50.5%), patient choice (22.5%), and less advanced liver disease (17.4%). Among treated patients, 15% discontinued prematurely because of serious adverse events. On the basis of multivariate analysis, factors associated with initiation of triple therapy included prior treatment relapse (odds ratio [OR], 4.6; 95% confidence interval [CI], 2.1-9.9) and liver fibrosis of stage 3 (OR, 9.1; 95% CI, 3.1-27) or stage 4 (OR, 9.0; 95% CI, 3.3-25) but not hepatic decompensation. CONCLUSIONS: Only 18.7% of patients with HCV genotype 1 infection received triple therapy in the 12 months after Food and Drug Administration approval of boceprevir and telaprevir. This low percentage might result from concerns of side effects and recognition that more effective medications could be available in the future.
BACKGROUND & AIMS: Protease inhibitor triple therapy for hepatitis C virus (HCV) infection (boceprevir or telaprevir with pegylated interferon and ribavirin) has been shown to increase rates of sustained virologic response in phase 3 trials. We investigated the proportion of patients who began therapy with this regimen in the 12 months after the Food and Drug Administration approval of boceprevir and telaprevir in the United States. METHODS: We performed a retrospective cross-sectional study of 487 patients with HCV genotype 1 infection (396 did not receive triple therapy, and 91 had begun triple therapy with boceprevir or telaprevir), who were seen at hepatology practices in Dallas and Miami from June 2011 through February 2012. The subjects were predominantly middle-aged, non-Hispanic white, and privately insured; 50% were treatment-naive, and most had advanced fibrosis. We compared features of patients who initiated triple therapy with those who deferred it. Treated patients were followed to determine the discontinuation rate in the first 12 weeks of treatment. RESULTS: Of patients assessed, only 18.7% began triple therapy, the same percentage as those receiving dual therapy (pegylated interferon and ribavirin) before boceprevir or telaprevir was approved for treatment of HCV infection in the United States. Reasons for deferring treatment included relative contraindications (50.5%), patient choice (22.5%), and less advanced liver disease (17.4%). Among treated patients, 15% discontinued prematurely because of serious adverse events. On the basis of multivariate analysis, factors associated with initiation of triple therapy included prior treatment relapse (odds ratio [OR], 4.6; 95% confidence interval [CI], 2.1-9.9) and liver fibrosis of stage 3 (OR, 9.1; 95% CI, 3.1-27) or stage 4 (OR, 9.0; 95% CI, 3.3-25) but not hepatic decompensation. CONCLUSIONS: Only 18.7% of patients with HCV genotype 1 infection received triple therapy in the 12 months after Food and Drug Administration approval of boceprevir and telaprevir. This low percentage might result from concerns of side effects and recognition that more effective medications could be available in the future.
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Authors: Winnie de Bruijn; Cristina Ibáñez; Pia Frisk; Hanne Bak Pedersen; Ali Alkan; Patricia Vella Bonanno; Ljiljana S Brkičić; Anna Bucsics; Guillaume Dedet; Jaran Eriksen; Joseph O Fadare; Jurij Fürst; Gisselle Gallego; Isabella P Godói; Augusto A Guerra Júnior; Hakkı Gürsöz; Saira Jan; Jan Jones; Roberta Joppi; Saim Kerman; Ott Laius; Newman Madzikwa; Einar Magnússon; Mojca Maticic; Vanda Markovic-Pekovic; Amos Massele; Olayinka Ogunleye; Aisling O'Leary; Jutta Piessnegger; Catherine Sermet; Steven Simoens; Celda Tiroyakgosi; Ilse Truter; Magnus Thyberg; Kristina Tomekova; Magdalena Wladysiuk; Sotiris Vandoros; Elif H Vural; Corinne Zara; Brian Godman Journal: Front Pharmacol Date: 2016-07-22 Impact factor: 5.810