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Gut Liver. 2018 Jan 15;12(1):86-93. doi: 10.5009/gnl17048.

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

Author information

1
Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
2
Department of Internal Medicine, Naga Municipal Hospital, Wakayama, Japan.

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.

KEYWORDS:

Asunaprevir; Daclatasvir; Genotype 1b; Hepacivirus

PMID:
28798288
PMCID:
PMC5753689
DOI:
10.5009/gnl17048
[Indexed for MEDLINE]
Free PMC Article

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