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dc.contributor.authorPuoti, M.
dc.contributor.authorFoster, G.R.
dc.contributor.authorWang, S.
dc.date.accessioned2019-06-21T18:46:28Z
dc.date.available2019-06-21T18:46:28Z
dc.date.issued2018
dc.identifier.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85047068884&doi=10.1016%2fj.jhep.2018.03.007&partnerID=40&md5=e000e144eabed4898e3988ccae646bea
dc.identifier.urihttp://hdl.handle.net/10713/9718
dc.description.abstractBackground & Aims: Glecaprevir plus pibrentasvir (G/P) is a pangenotypic, once-daily, ribavirin-free direct-acting antiviral (DAA) treatment for hepatitis C virus (HCV) infection. In nine phase II or III clinical trials, G/P therapy achieved rates of sustained virologic response 12 weeks after treatment (SVR12) of 93–100% across all six major HCV genotypes (GTs). An integrated efficacy analysis of 8- and 12-week G/P therapy in patients without cirrhosis with HCV GT 1–6 infection was performed. Methods: Data were pooled from nine phase II and III trials including patients with chronic HCV GT 1–6 infection without cirrhosis who received G/P (300 mg/120 mg) for either 8 or 12 weeks. Patients were treatment naïve or treatment experienced with peginterferon, ribavirin, and/or sofosbuvir; all patients infected with HCV GT 3 were treatment naïve. Efficacy was evaluated as the SVR12 rate. Results: The analysis included 2,041 patients without cirrhosis. In the intent-to-treat population, 943/965 patients (98%) achieved SVR12 when treated for eight weeks, and 1,060/1,076 patients (99%) achieved SVR12 when treated for 12 weeks; the difference in rates was not significant (p = 0.2). A subgroup analysis demonstrated SVR12 rates > 95% across baseline factors traditionally associated with lower efficacy. G/P was well tolerated, with one DAA-related serious adverse event (<0.1%); grade 3 laboratory abnormalities were rare. Conclusions: G/P therapy for eight weeks in patients with chronic HCV GT 1–6 infection without cirrhosis achieved an overall SVR12 rate of 98% irrespective of baseline patient or viral characteristics; four additional weeks of treatment did not significantly increase the SVR12 rate, demonstrating that the optimal treatment duration in this population is eight weeks. Copyright 2018 European Association for the Study of the Liveren_US
dc.description.urihttps://dx.doi.org/10.1016/j.jhep.2018.03.007en_US
dc.language.isoen-USen_US
dc.publisherElsevier B.V.en_US
dc.relation.ispartofJournal of Hepatology
dc.subjectDirect-acting antiviralen_US
dc.subjectHepatitis Cen_US
dc.subjectPangenotypicen_US
dc.subjectShort durationen_US
dc.titleHigh SVR12 with 8-week and 12-week glecaprevir/pibrentasvir therapy: An integrated analysis of HCV genotype 1–6 patients without cirrhosisen_US
dc.typeArticleen_US
dc.identifier.doi10.1016/j.jhep.2018.03.007


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