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您的检索式：作者名="Triin Umbleja"
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| 1 | Phase 3 trial of first generation protease inhibitor therapy for hepatitis C virus/human immunodeficiency virus coinfection显示文摘AIM To evaluate efficacy/safety of hepatitis C virus(HCV) protease inhibitor boceprevir with pegylated interferon(PEG-IFN) alfa and weight-based ribavirin(RBV) in a phase 3 trial. METHODS A prospective, multicenter, phase 3, open-label, singlearm study of PEG-IFN alfa, weight-based RBV, and boceprevir, with a PEG-IFN/RBV lead-in phase was performed. The HCV/human immunodeficiency virus coinfected study population included treatment na?ve(TN) and treatment experienced(TE) patients. Treatment duration ranged from 28 to 48 wk dependent upon response-guided criteria. All patients had HCV Genotype 1 with a viral load > 10000 IU/ml. Compensated cirrhosis was allowed. Sample size was determined to establish superiority to historical(PEG-IFN plus RBV) rates in sustained viral response(SVR). RESULTS A total of 257 enrolled participants were analyzed(135 TN and 122 TE). In the TN group, 81.5% were male and 54.1% were black. In the TE group, 76.2% were male and 47.5% were white. Overall SVR12 rates(HCV RNA < lower limit of quantification, target not detected, target not detected) were 35.6% in TN and 30.3% in TE. Response rates at SVR24 were 28% in TN and 10% in TE, and exceeded those in historical controls. The highest rate was observed in TN non-cirrhotic participants(36.8% and the lowest in TE cirrhotics(26.3%). Cirrhotic TN participants had a 27.8% SVR12 rate and 32.1% of TE non-cirrhotics achieved SVR12. Significantly lower response rates were observed among black participants; in the TE, SVR12 was 39.7% in white participants but only 13.2% of black subjects(P = 0.002). Among the TN, SVR12 was 42.1% among whites and 27.4% among blacks(P = 0.09). CONCLUSION The trial met its hypothesis of improved SVR compared to historical controls but overall SVR rates were low. All-oral HCV treatments will mitigate these difficulties. | Kenneth E Sherman Minhee Kang Richard Sterling Triin Umbleja Kristen Marks Jennifer J Kiser Beverly Alston-Smith Wayne Greaves Adeel A Butt 无 | 2017 | World Journal of Hepatology2017，9，4： | 0 |
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