Gut Liver.  2018 Jan;12(1):86-93. 10.5009/gnl17048.

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

• Taki S
• Tamai H
• Ida Y
• Shingaki N
• Kawashima
• Shimizu R
• Moribata K
• Maekita T
• Iguchi M
• Kato J
• Nakao T
• Kitano M

• KMID: 2404722
• DOI: http://doi.org/10.5009/gnl17048

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.

Keyword

Hepacivirus; Genotype 1b; Daclatasvir; Asunaprevir

MeSH Terms

Aged*
Hepacivirus
Humans
Interferons
Japan
Simeprevir
Interferons
Simeprevir