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dc.contributor.authorZeuzem, S
dc.contributor.authorFoster, GR
dc.contributor.authorWang, S
dc.contributor.authorAsatryan, A
dc.contributor.authorGane, E
dc.contributor.authorFeld, JJ
dc.contributor.authorAsselah, T
dc.contributor.authorBourlière, M
dc.contributor.authorRuane, PJ
dc.contributor.authorWedemeyer, H
dc.contributor.authorPol, S
dc.contributor.authorFlisiak, R
dc.contributor.authorPoordad, F
dc.contributor.authorChuang, W-L
dc.contributor.authorStedman, CA
dc.contributor.authorFlamm, S
dc.contributor.authorKwo, P
dc.contributor.authorDore, GJ
dc.contributor.authorSepulveda-Arzola, G
dc.contributor.authorRoberts, SK
dc.contributor.authorSoto-Malave, R
dc.contributor.authorKaita, K
dc.contributor.authorPuoti, M
dc.contributor.authorVierling, J
dc.contributor.authorTam, E
dc.contributor.authorVargas, HE
dc.contributor.authorBruck, R
dc.contributor.authorFuster, F
dc.contributor.authorPaik, S-W
dc.contributor.authorFelizarta, F
dc.contributor.authorKort, J
dc.contributor.authorFu, B
dc.contributor.authorLiu, R
dc.contributor.authorNg, TI
dc.contributor.authorPilot-Matias, T
dc.contributor.authorLin, C-W
dc.contributor.authorTrinh, R
dc.contributor.authorMensa, FJ
dc.description.abstractBACKGROUND: Glecaprevir and pibrentasvir are direct-acting antiviral agents with pangenotypic activity and a high barrier to resistance. We evaluated the efficacy and safety of 8-week and 12-week courses of treatment with 300 mg of glecaprevir plus 120 mg of pibrentasvir in patients without cirrhosis who had hepatitis C virus (HCV) genotype 1 or 3 infection. METHODS: We conducted two phase 3, randomized, open-label, multicenter trials. Patients with genotype 1 infection were randomly assigned in a 1:1 ratio to receive once-daily glecaprevir-pibrentasvir for either 8 or 12 weeks. Patients with genotype 3 infection were randomly assigned in a 2:1 ratio to receive 12 weeks of treatment with either glecaprevir-pibrentasvir or sofosbuvir-daclatasvir. Additional patients with genotype 3 infection were subsequently enrolled and nonrandomly assigned to receive 8 weeks of treatment with glecaprevir-pibrentasvir. The primary end point was the rate of sustained virologic response 12 weeks after the end of treatment. RESULTS: In total, 1208 patients were treated. The rate of sustained virologic response at 12 weeks among genotype 1-infected patients was 99.1% (95% confidence interval [CI], 98 to 100) in the 8-week group and 99.7% (95% CI, 99 to 100) in the 12-week group. Genotype 3-infected patients who were treated for 12 weeks had a rate of sustained virologic response at 12 weeks of 95% (95% CI, 93 to 98; 222 of 233 patients) with glecaprevir-pibrentasvir and 97% (95% CI, 93 to 99.9; 111 of 115) with sofosbuvir-daclatasvir; 8 weeks of treatment with glecaprevir-pibrentasvir yielded a rate of 95% (95% CI, 91 to 98; 149 of 157 patients). Adverse events led to discontinuation of treatment in no more than 1% of patients in any treatment group. CONCLUSIONS: Once-daily treatment with glecaprevir-pibrentasvir for either 8 weeks or 12 weeks achieved high rates of sustained virologic response among patients with HCV genotype 1 or 3 infection who did not have cirrhosis. (Funded by AbbVie; ENDURANCE-1 and ENDURANCE-3 numbers, NCT02604017 and NCT02640157 .).en_US
dc.description.sponsorshipThe trials (NCT02604017, NCT02640157) were funded by AbbVie Inc.en_US
dc.format.extent354 - 369
dc.publisherMassachusetts Medical Societyen_US
dc.relation.ispartofN Engl J Med
dc.rightsFrom N Engl J Med, Zeuzem et al., Glecaprevir–Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection, 378:354-369. Copyright © 2018 Massachusetts Medical Society. Reprinted with permission.
dc.titleGlecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.en_US
dc.rights.holderCopyright © 2018, Massachusetts Medical Society
pubs.organisational-group/Queen Mary University of London
pubs.organisational-group/Queen Mary University of London/Faculty of Medicine & Dentistry
pubs.organisational-group/Queen Mary University of London/Faculty of Medicine & Dentistry/Blizard Institute
pubs.organisational-group/Queen Mary University of London/Faculty of Medicine & Dentistry/Blizard Institute/Immunobiology

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