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Sofosbuvir‐Daclatasvir is suboptimal in patients with genotype 2 chronic hepatitis C infection: real‐life experience from the HEPATHER ANRS CO22 cohort
Authors:Victor de Ldinghen  Clovis Lusivika‐Nzinga  Jean‐Pierre Bronowicki  Fabien Zoulim  Dominique Larrey  Sophie Metivier  Albert Tran  Patrick Marcellin  Didier Samuel  Olivier Chazouillres  Stephane Chevaliez  Celine Dorival  Hlne Fontaine  Jean‐Michel Pawlotsky  Fabrice Carrat  Stanislas Pol
Institution:Victor de Lédinghen,Clovis Lusivika‐Nzinga,Jean‐Pierre Bronowicki,Fabien Zoulim,Dominique Larrey,Sophie Metivier,Albert Tran,Patrick Marcellin,Didier Samuel,Olivier Chazouillères,Stephane Chevaliez,Celine Dorival,Hélène Fontaine,Jean‐Michel Pawlotsky,Fabrice Carrat,Stanislas Pol,
Abstract:Sofosbuvir plus daclatasvir with or without ribavirin has demonstrated a high efficacy and an acceptable safety profile in clinical trials of patients infected with genotype 2 hepatitis Cvirus (HCV); however, there are currently no real‐world data available for this regimen. To evaluate the real‐life safety and efficacy of sofosbuvir/daclatasvir with or without ribavirin in genotype 2 HCV patients in the French cohort ANRS CO22 HEPATHER(NCT01953458). In this ongoing, national, multicentre, prospective, observational study, we observed patients with HCV genotype 2 infection who initiated treatment with sofosbuvir (400 mg/d) plus daclatasvir with or without ribavirin (1‐1.2 g/d). Patients were divided into two treatment groups: sofosbuvir/daclatasvir with or without ribavirin (12 weeks/24 weeks). The primary end point was a sustained virological response at week 12 following the end of therapy. Overall, 88% and 91% of patients achieved a sustained virological response following 12 and 24 weeks of treatment with sofosbuvir/daclatasvir with or without ribavirin, respectively. The most common adverse events were asthenia (29%), headache (15%) and fatigue (20%), and ribavirin addition was associated with a higher rate of adverse events and treatment discontinuation. Sofosbuvir/daclatasvir with or without ribavirin was associated with lower rates of sustained virological response in the real‐life setting compared with the clinical setting and demonstrated suboptimal efficacy for the treatment of patients with genotype 2 chronic HCV.
Keywords:daclatasvir  direct‐acting antivirals  genotype 2  HEPATHER  Hepatitis C  real‐world  sofosbuvir
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