AIM To assess dacl.tasvir pl.s asunaprevir(d UAl. in treatment-na?ve patients from China's Mainl.nd, Russia and South Korea with hepatitis C virus(HCV) genotype 1 b infection. METHODS Patients were randoml. assigned(3...
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AIM To assess dacl.tasvir pl.s asunaprevir(d UAl. in treatment-na?ve patients from China's Mainl.nd, Russia and South Korea with hepatitis C virus(HCV) genotype 1 b infection. METHODS Patients were randoml. assigned(3:1) to receive 24 wk of treatment with d UAl.dacl.tasvir 60 mg once dail. and asunaprevir 100 mg twice dail.) beginning on day 1 of the treatment period(immediate treatment arm) or fol.owing 12 wk of matching pl.cebo(pl.cebodeferred treatment arm). The primary endpoint was a comparison of sustained virol.gic response at posttreatment week 12(SVR12) compared with the historical.SVR rate for peg-interferon pl.s ribavirin(70%) among patients in the immediate treatment arm. The first 12 wk of the study were bl.nded. Safety was assessed in d UAl.treated patients compared with pl.cebo patients during the first 12 wk(doubl.bl.nd phase), and during 24 wk of d UAl.in both arms *** In total. 207 patients were randoml. assigned to immediate(n = 155) or pl.cebo-deferred(n = 52) treatment. Most patients were Asian(86%), femal.(59%) and aged l.8 B non-CC genotypes and 53% had basel.ne HCV RNA l.vel. of ≥ 6 mil.ion IU/m l. Among patients in the immediate treatment arm, SVR12 was achieved by 92%(95% confidence interval. 87.2-96.0), which was significantl. higher than the historical.comparator rate(70%). SVR12 was l.rgel. unaffected by cirrhosis(89%), age ≥ 65 years(92%), mal. sex(90%), basel.ne HCV RNA ≥ 6 mil.ion(89%) or Il.8 B non-CC genotypes(96%), al.hough SVR12 was higher among patients without(96%) than among those with(53%) basel.ne NS5 A resistanceassociated pol.morphisms(at l.1 or Y93 H). during the doubl.-bl.nd phase, aminotransferase el.vations were more common among pl.cebo recipients than among patients receiving d UAl. during 24 wk of d UAl.therapy(combined arms), the most common adverse events(≥ 10%) were el.vated al.nine aminotransferase and upper respiratory tract infection; emergent
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