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KMID : 1188320180120010086
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Gut and Liver
2018 Volume.12 No. 1 p.86 ~ p.93
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The Real-World Safety and Efficacy of Daclatasvir and Asunaprevir for Elderly Patients
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Taki Shinya
Tamai Hideyuki
Ida Yoshiyuki
Shingaki Naoki
Kawashima Akira
Shimizu Ryo
Moribata Kosaku
Maekita Takao
Iguchi Mikitaka
Kato Jun
Nakao Taisei
Kitano Masayuki
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Abstract
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Background/Aims: Although 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.
Conclusions: Daclatasvir 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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KEYWORD
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Hepacivirus, Genotype 1b, Daclatasvir, Asunaprevir
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