Efficacy and safety of glecaprevir/pibrentasvir as retreatment therapy for patients with genotype 2 chronic hepatitis C who failed prior sofosbuvir plus ribavirin regimen

Atsunori Kusakabe; Masayuki Kurosaki; Jun Itakura; Kouji Joko; Takehiro Akahane; Keiji Tsuji; Haruhiko Kobashi; Tetsuro Sohda; Hiroyuki Kimura; Ryouichi Narita; Koichirou Furuta; Namiki Izumi

doi:10.1111/hepr.13387

Efficacy and safety of glecaprevir/pibrentasvir as retreatment therapy for patients with genotype 2 chronic hepatitis C who failed prior sofosbuvir plus ribavirin regimen

Hepatol Res. 2019 Oct;49(10):1121-1126. doi: 10.1111/hepr.13387. Epub 2019 Jul 10.

Authors

Affiliations

¹ Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.
² Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.
³ Center for Liver-Biliary-Pancreatic Diseases, Matsuyama Red Cross Hospital, Matsuyama, Japan.
⁴ Department of Gastroenterology, Japanese Red Cross Ishinomaki Hospital, Ishinomaki, Japan.
⁵ Department of Gastroenterology, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima, Japan.
⁶ Department of Hepatology, Japanese Red Cross Okayama Hospital, Okayama, Japan.
⁷ Department of Hepatology, Japanese Red Cross Fukuoka Hospital, Fukuoka, Japan.
⁸ Department of Gastroenterology, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan.
⁹ Department of Gastroenterology, Oita Red Cross Hospital, Oita, Japan.
¹⁰ Department of Gastroenterology, Masuda Red Cross Hospital, Masuda, Japan.

PMID: 31209976
DOI: 10.1111/hepr.13387

Abstract

Aim: Rescue therapy for patients with genotype 2 (GT2) chronic hepatitis C who failed prior sofosbuvir (SOF) plus ribavirin (RBV) awaits establishment. This study aims to investigate the efficacy and safety of the fixed-dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg) (GLE/PIB) for patients with GT2 chronic hepatitis C.

Methods: In this nationwide observational study undertaken by the Japanese Red Cross Liver Study Group, 28 GT2 patients with prior failure of SOF + RBV were retreated with GLE/PIB for 12 weeks. We evaluated the rate of sustained virologic response (SVR) and adverse events.

Results: After 4 weeks of therapy, serum hepatitis C virus RNA was below the limit of quantification in all patients. The SVR after 4 and 12 weeks of the end of treatment was validated in 100% (28/28) and 100% (28/28), respectively. The adverse events comprised pruritus (eight patients), fatigue (four patients), and appetite loss (four patients), all of which were mild in severity.

Conclusions: This study establishes the efficacy of GLE/PIB as retreatment in Japanese patients with GT2 chronic hepatitis C not responding to SOF + RBV.

Keywords: chronic hepatitis C; glecaprevir; pibrentasvir; retreatment.

Grants and funding

15fk0210007h0002/Japan Agency for Medical Research and Development'.