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Hepatitis C i)Hepatitis C and HCC(II)
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| タイトル |
IF4c-4 Successful Therapy with the NS5A Inhibitor Daclatasvir and NS3 Protease Inhibitor Asunaprevir in HCV Genotype 1B-infected Null Responders or Ineligible／Intolerant to PEG-IFN／RBV
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| 共同演者 |
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| 抄録 |
Background ： Regimens for chronic HCV infection that combine 2 direct－acting antivirals （DAAs）withoutpeginterferon and ribavirin （peg－alfa／RBV）may benefit many infected patients． This study evaluatesdaclatasvir （DCV）a highly selective NSsA replication complex inhibitorcombined with asunaprevir（ASV）a potentselective inhibitor of HCV NS3 proteasein patients with peg－aifa／RBV intolerance orprior null response to peg－a］fa／RBV． M ethods ： This open－label study enrolled 21 null responders （groupA） and 22 patients ineligible for interferon containing regimens for medical reasons or who discontinuedpeg－alfa／RBV after〈12 weeks due to intolerance （group B）． Patients received DCV 60mg QD and ASV200mg BID （initially 600mg BID in 10／21 subj ects in group A） for 24 weeks． Addition of peg－alfa／RBV waspermitted for Group A patients with virologic failure． Results ： All 43 enrolled patients were J apanesewith HCV genotype l b． Baseline characteristics were similar other than a higher proportion of IL28Bgenotype CC （rs 12979860） in group B vs A （730／o vs 140／o）． Undetectable at Week24 was achieved by 860／oand 730／o of patients in groups A and Brespectively． Three pabients discontinued prematurely for adverseevents （AE）1 for lack of efficacy2 due to patient requestand 1 （group A） for lack of efficacy requiringaddition of peg－aifa／RBV． Three patients had viral breakthrough1 before week 12 ； HCV variants associ－ated’ with ASV and DCV resistance were identified． Serious AE included 2 Group A patients （1 hyper－bilirubinemia／gastroenteritis1 pyrexia） receiving ASV 600 mg BIDand 3 Group B patients 〈2 pyrexia1 hypochondriasis）． Conclusions ： The dual oral DAA combination of DCV and ASVwithout peg－alfa／RBVmay offer a needed therapeutic alternative to peg－aifa／RBV￡ontaining regimens for many patientsincluding some difficult－to－treat groups． |
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