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Journal articles

Daclatasvir plus simeprevir with or without ribavirin for the treatment of chronic hepatitis C virus genotype 1 infection

Stefan Zeuzem 1, * Christophe Hezode 2 Jean-Pierre Bronowicki 3, 4 Veronique Loustaud-Ratti 5 Francisco Gea 6 Maria Buti 7 Antonio Olveira 6 Tivadar Banyai 8 M. Tarek Al-Assi 9 Joerg Petersen 10 Dominique Thabut 11 Adrian Gadano 12 Ronald Pruitt 13 Mihaly Makara 14 Marc Bourliere 15, 16 Stanislas Pol 17, 18 Maria Beumont-Mauviel 19 Sivi Ouwerkerk-Mahadevan 19 Gaston Picchio 19 Marc Bifano 20 Fiona Mcphee 20 Navdeep Boparai 20 Kin Cheung 20 Eric A. Hughes 20 Stephanie Noviello 20 
Abstract : BACKGROUND & AIMS: We evaluated the combination of daclatasvir (pan-genotypic NS5A inhibitor) and simeprevir (NS3/4A protease inhibitor), with or without ribavirin, in hepatitis C virus genotype 1-infected patients. METHODS: This phase II, open-label study enrolled treatment-naive patients or prior null responders with genotype 1b (n=147) or 1a (n=21) infection. Genotype 1b-infected patients were randomized 1:1 to receive daclatasvir 30mg plus simeprevir 150mg once daily with or without ribavirin; those who completed the initial 12-week treatment were re-randomized 1:1 to stop treatment or continue treatment through to week 24. Genotype 1a-infected patients received daclatasvir plus simeprevir with ribavirin for 24weeks. The primary endpoint was the proportion of patients with sustained virologic response at posttreatment week 12 (SVR12). RESULTS: For genotype 1b, 84.9% (45/53) and 74.5% (38/51) of treatment-naive patients and 69.6% (16/23) and 95.0% (19/20) of prior null responders to peginterferon and ribavirin achieved SVR12 with daclatasvir plus simeprevir alone and with ribavirin, respectively. Treatment duration did not have a well-defined impact on response. For genotype 1a, daclatasvir plus simeprevir with ribavirin provided a 66.7% (8/12) response rate in treatment-naive patients and was not effective in prior null responders. Data suggest that baseline resistance polymorphisms influenced SVR12 rates. Daclatasvir plus simeprevir was well tolerated with or without ribavirin with low incidences of serious adverse events and adverse events leading to discontinuation. CONCLUSIONS: Daclatasvir plus simeprevir, with or without ribavirin, was effective with a 12- or 24-week duration in genotype 1b-infected patients and was well tolerated. identifier: NCT01628692.
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Submitted on : Friday, December 8, 2017 - 10:08:55 AM
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Stefan Zeuzem, Christophe Hezode, Jean-Pierre Bronowicki, Veronique Loustaud-Ratti, Francisco Gea, et al.. Daclatasvir plus simeprevir with or without ribavirin for the treatment of chronic hepatitis C virus genotype 1 infection. Journal of Hepatology, Elsevier, 2016, 64 (2), pp.292-300. ⟨10.1016/j.jhep.2015.09.024⟩. ⟨hal-01659111⟩



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