Randomized trial of daclatasvir and asunaprevir with or without PegIFN/RBV for hepatitis C virus genotype 1 null responders
作者： Anna S. Lok , David F. Gardiner , Christophe Hézode , Eric J. Lawitz , Marc Bourlière
DOI: 10.1016/J.JHEP.2013.10.019
关键词:
摘要: Background & Aims Patients with chronic hepatitis C virus (HCV) infection and prior null response ( Methods In this randomized, phase 2a, open-label, 24-week treatment study, 101 patients received daclatasvir (60mg) once-daily. addition, 38 genotype 1b asunaprevir (200mg) twice- (DUAL A1) or once-daily A2); 36 1a 5 (QUAD B1) B2) plus PegIFN/RBV; 18 4 twice-daily ribavirin (TRIPLE B3). The primary endpoint was undetectable HCV RNA 12weeks post-treatment (sustained virologic response, SVR 12 ). Results Across all groups, mean ⩾6 log IU/ml, 99% of had a non-CC IL28B genotype. rates were 78% (A1), 65% (A2), 95% (B1), (B2). B3, most experienced breakthrough. common adverse events headache, diarrhea, asthenia. Grade 3–4 aminotransferase elevations infrequent not treatment-limiting. Conclusions 1 responders, DUAL therapy is effective for patients, daclatasvir, asunaprevir, PegIFN/RBV QUAD nearly patients; but neither nor TRIPLE patients. Interferon-free regimens including responders should be tailored to subtype.
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