Safety and efficacy of glecaprevir and pibrentasvir in Japanese hemodialysis patients with genotype 2 hepatitis C virus infection.

Abstract

BACKGROUND:

Until recently, interferon-free anti-hepatitis C virus (HCV) therapy for genotype 2 (GT2) HCV-infected hemodialysis patients was an unfulfilled medical need. Recent clinical trials of glecaprevir and pibrentasvir (G/P) for hemodialysis patients showed high efficacy and safety; however, the number of GT2 HCV-infected patients, especially Asian patients, was limited and most of them were treated with a 12-week regimen. In this prospective multicenter study, we aimed to investigate the efficacy and safety of G/P in Japanese hemodialysis patients with GT2 HCV infection.

METHODS:

Twenty-seven Japanese hemodialysis patients with GT2 HCV infection who were started on with 8- or 12-week G/P regimen between November 2017 and June 2018 were included and followed up for around 12 weeks after treatment completion.

RESULTS:

Among the 27 included patients, 13 non-liver cirrhosis (LC) and direct-acting antivirals (DAAs)-naïve patients were treated with 8 weeks of G/P and 14 patients with LC (n = 13) or history of failure of DAAs (n = 1) were treated with a 12-week regimen. The overall sustained virological response at 12 weeks after treatment completion (SVR 12) was 96.3% (26/27). All patients with 8 weeks of treatment achieved SVR12. Two patients discontinued the therapy at 2 and 11 weeks after treatment initiation. The patient who discontinued at 2 weeks due to pruritus alone failed to respond to G/P. No patients experienced lethal adverse events during the therapy, and the most common adverse event was pruritus.

CONCLUSIONS:

An 8- or 12-week G/P regimen is highly effective and safe in GT2 HCV-infected hemodialysis patients.

• Authors: Goki Suda, Chitomi Hasebe, Masami Abe, Masayuki Kurosaki, Jun Itakura, Namiki Izumi, Yoshihito Uchida, Satoshi Mochida, Hiroaki Haga, Yoshiyuki Ueno, Kazumichi Abe, Atsushi Takahashi, Hiromasa Ohira, Yoko Tsukuda, Ken Furuya, Masaru Baba, Yoshiya Yamamoto, Tomoe Kobayashi, Jun Inoue, Katsumi Terasita, Masatsugu Ohara, Naoki Kawagishi, Takaaki Izumi, Masato Nakai, Takuya Sho, Mitsuteru Natsuizaka, Kenichi Morikawa, Koji Ogawa, Naoya Sakamoto, NORTE Study Group
• Journal: Journal of gastroenterology (J Gastroenterol) Vol. 54 Issue 7 Pg. 641-649 (Jul 2019) ISSN: 1435-5922 [Electronic] Japan
• PMID: 30778716 (Publication Type: Journal Article, Multicenter Study)

Chemical References

• Antiviral Agents
• Benzimidazoles
• Drug Combinations
• Pyrrolidines
• Quinoxalines
• Sulfonamides
• glecaprevir and pibrentasvir

Topics

• Aged
• Antiviral Agents (adverse effects, therapeutic use)
• Benzimidazoles (adverse effects, therapeutic use)
• Drug Combinations
• Female
• Genotype
• Hepacivirus (genetics)
• Hepatitis C, Chronic (drug therapy)
• Humans
• Japan
• Liver Cirrhosis (drug therapy, pathology)
• Male
• Middle Aged
• Prospective Studies
• Pyrrolidines (adverse effects, therapeutic use)
• Quinoxalines (adverse effects, therapeutic use)
• Renal Dialysis
• Sulfonamides (adverse effects, therapeutic use)
• Sustained Virologic Response
• Treatment Outcome