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Multicenter Study
. 2022 Apr 28;22(1):210.
doi: 10.1186/s12876-022-02284-z.

Efficacy and safety of glecaprevir and pibrentasvir in Japanese patients with hepatitis C virus infection aged 75 years or older

Yuri Komaki  1 , Yoshinori Ozono  1 , Kenichi Nakamura  1 , Hisayoshi Iwakiri  1 , Satoru Hasuike  1 , Mitsue Sueta  1 , Tadashi Miike  1 , Shojiro Yamamoto  1 , Hirofumi Uto  2 , Kazunori Kusumoto  3 , Toshimasa Ochiai  3 , Junya Kato  4 , Naoto Komada  4 , Kazuo Kuroki  5 , Toshiharu Eto  5 , Masafumi Shigehira  6 , Shuichi Hirono  7 , Kenji Nagata  1 , Hiroshi Kawakami  8
Affiliations
Multicenter Study

Efficacy and safety of glecaprevir and pibrentasvir in Japanese patients with hepatitis C virus infection aged 75 years or older

Yuri Komaki et al. BMC Gastroenterol. .

Abstract

Background: It is estimated that approximately 50% of patients with hepatitis C virus (HCV) infection in Japan are currently over 75 years old. However, patients aged ≥ 75 years are typically underrepresented in clinical trials of direct-acting antivirals. This study aimed to evaluate the efficacy and safety of glecaprevir and pibrentasvir (G/P) treatment in Japanese patients with HCV infection aged ≥ 75 years.

Methods: This multicenter, retrospective study included 271 Japanese patients with HCV infection from 12 centers in Miyazaki Prefecture, Japan. Demographic, clinical, virological, and adverse events (AEs) data obtained during and after G/P treatment were collected from medical records. The patients were divided into two groups: younger (n = 199, aged < 75 years) and older (n = 72, aged ≥ 75 years). Virological data and AEs were analyzed according to the age group.

Results: In intention-to-treat (ITT) and per-protocol analyses, the overall sustained virological response 12 (SVR12) rates were 93% and 98.8%, respectively. Two patients in the older group and 14 patients in the younger group dropped out before SVR12 assessment. Although patients in the older group tended to have liver cirrhosis, 95.8% in the older group and 92% in the younger group achieved SVR12 in the ITT analysis (P = 0.404). In total, 48 (17.7%) patients experienced treatment-related AEs. Common AEs during treatment included pruritus, headache, and fatigue. The AEs were not significantly different between the two groups.

Conclusions: Compared with younger patients, older patients showed similar virological response and tolerance to G/P treatment.

Keywords: Chronic hepatitis C; Direct-acting antivirals; Glecaprevir; Pibrentasvir; Sustained virological response.

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Conflict of interest statement

The authors declare that there are no conflicts of interest regarding the publication of this paper.

Figures

Fig. 1
Fig. 1
Flowchart of patient selection
Fig. 2
Fig. 2
SVR12 rates for each parameter. a age, b gender, c genotype, d HCV viral load, e liver status, f FIB-4 index, g prior HCV treatment, h history of HCC, i presence of NS5A RASs, j eGFR
See this image and copyright information in PMC

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