The Real-World Safety and Efficacy of Daclatasvir and Asunaprevir for Elderly Patients
- Author:
Shinya TAKI
1
;
Hideyuki TAMAI
;
Yoshiyuki IDA
;
Naoki SHINGAKI
;
Akira KAWASHIMA
;
Ryo SHIMIZU
;
Kosaku MORIBATA
;
Takao MAEKITA
;
Mikitaka IGUCHI
;
Jun KATO
;
Taisei NAKAO
;
Masayuki KITANO
Author Information
- Publication Type:Original Article
- Keywords: Hepacivirus; Genotype 1b; Daclatasvir; Asunaprevir
- MeSH: Aged; Hepacivirus; Humans; Interferons; Japan; Simeprevir
- From:Gut and Liver 2018;12(1):86-93
- CountryRepublic of Korea
- Language:English
- Abstract: 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.
