Gut and Liver (Jan 2018)

The Real-World Safety and Efficacy of Daclatasvir and Asunaprevir for Elderly Patients

  • Shinya Taki,
  • Hideyuki Tamai,
  • Yoshiyuki Ida,
  • Naoki Shingaki,
  • Akira Kawashima,
  • Ryo Shimizu,
  • Kosaku Moribata,
  • Takao Maekita,
  • Mikitaka Iguchi,
  • Jun Kato,
  • Taisei Nakao,
  • Masayuki Kitano

DOI
https://doi.org/10.5009/gnl17048
Journal volume & issue
Vol. 12, no. 1
pp. 86 – 93

Abstract

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Background/AimsAlthough daclatasvir with asunaprevir was approved in Japan for interferon ineligible or intolerant patients, patients aged ≥75 years were excluded in the phase III trial. The present study aimed to evaluate the safety and efficacy of this therapy for elderly patients aged ≥75 years and to clarify whether an extremely high sustained virological response (SVR) rate can be achieved, even in a real-world setting when patients with resistance-associated substitutions (RASs) to nonstructural protein 5A (NS5A) inhibitors or prior simeprevir failure are excluded.Methods : Daclatasvir (60 mg) and asunaprevir (100 mg) were orally administered daily for 24 weeks. Patients without pre-existing NS5A RASs and simeprevir failure were enrolled in this study.Results : Overall, 110 patients were treated. The median age was 73 years old. The SVR rates of total patients, those aged ≥75 years, and those aged <75 years were 97% (107/110), 98% (46/47), and 97% (61/63), respectively. The treatment of two patients (2%) was discontinued because of adverse events.Conclusion : sDaclatasvir with asunaprevir was a safe treatment, even in patients aged ≥75 years. When patients without pre-existing NS5A RASs and prior simeprevir failure were selected, an extremely high SVR rate could be achieved irrespective of age.

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