Published online Dec 28, 2017. doi: 10.4254/wjh.v9.i36.1340
Peer-review started: August 26, 2017
First decision: September 20, 2017
Revised: October 10, 2017
Accepted: November 3, 2017
Article in press: November 3, 2017
Published online: December 28, 2017
To evaluate the efficacy and safety of a regimen containing sofosbuvir (SOF) and ledipasvir (LDV) in Japanese patients aged ≥ 75 years with hepatitis C genotype 1.
This multicenter, retrospective study consisted of 246 Japanese patients with HCV genotype 1 at nine centers in Miyazaki prefecture in Japan. Demographic, clinical, virological, and adverse effects (AE)-related data obtained during and after SOF/LDV therapy were collected from medical records. These patients were divided into two groups, younger (aged < 75 years) and elderly (aged ≥ 75 years). Virological data and AEs were analyzed by age group.
The sustained virological response (SVR) rates at 12 wk after treatment were 99.2%, 99.4%, and 98.7% in the overall population and in patients aged < 75 and ≥ 75 years, respectively. Common AEs during therapy were headache, pruritus, constipation, and insomnia. These occurred in fewer than 10% of patients, and their incidence was not significantly different between the younger and elderly groups. Two patients discontinued treatment, one due to a skin eruption and the other due to cerebral bleeding.
Compared with younger patients, elderly patients had a similar virological response and tolerance to SOF/LDV therapy.
Core tip: Most Japanese patients with hepatitis C are elderly, and those aged ≥ 75 years account for more than 50%. However there are few reports regarding sofosbuvir (SOF) and ledipasvir (LDV) therapy in patients aged ≥ 75 years in the real-world. The present study demonstrated that patients aged ≥ 75 years had a similar virological response and tolerance to SOF/LDV therapy compared with patients aged < 75 years in the real-world cohorts. Therefore, SOF/LDV therapy might be effective and safe in elderly patients.