Real-world efficacy and safety of sofosbuvir + ribavirin for hepatitis C genotype 2: A nationwide multicenter study by the Japanese Red Cross Liver Study Group

Takehiro Akahane; Masayuki Kurosaki; Jun Itakura; Keiji Tsuji; Kouji Joko; Hiroyuki Kimura; Akihiro Nasu; Chikara Ogawa; Yuji Kojima; Chitomi Hasebe; Shuichi Wada; Yasushi Uchida; Tetsuro Sohda; Hideyuki Suzuki; Hideo Yoshida; Atsunori Kusakabe; Takashi Tamada; Haruhiko Kobashi; Akeri Mitsuda; Masahiko Kondo; Masaya Shigeno; Yasushi Ide; Atsuhiro Morita; Tadashi Kitamura; Takehiko Abe; Namiki Izumi

doi:10.1111/hepr.13246

Real-world efficacy and safety of sofosbuvir + ribavirin for hepatitis C genotype 2: A nationwide multicenter study by the Japanese Red Cross Liver Study Group

Hepatol Res. 2019 Mar;49(3):264-270. doi: 10.1111/hepr.13246. Epub 2018 Oct 20.

Authors

Takehiro Akahane¹, Masayuki Kurosaki², Jun Itakura², Keiji Tsuji³, Kouji Joko⁴, Hiroyuki Kimura⁵, Akihiro Nasu⁶, Chikara Ogawa⁷, Yuji Kojima⁸, Chitomi Hasebe⁹, Shuichi Wada¹⁰, Yasushi Uchida¹¹, Tetsuro Sohda¹², Hideyuki Suzuki¹³, Hideo Yoshida¹⁴, Atsunori Kusakabe¹⁵, Takashi Tamada¹⁶, Haruhiko Kobashi¹⁷, Akeri Mitsuda¹⁸, Masahiko Kondo¹⁹, Masaya Shigeno²⁰, Yasushi Ide²¹, Atsuhiro Morita²², Tadashi Kitamura²³, Takehiko Abe²⁴, Namiki Izumi²

Affiliations

¹ Department of Gastroenterology, Japanese Red Cross Ishinomaki Hospital, Ishinomaki, Japan.
² Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Musashino, Japan.
³ Department of Gastroenterology, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima, Japan.
⁴ Center for Liver-Biliary-Pancreatic Diseases, Matsuyama Red Cross Hospital, Matsuyama, Japan.
⁵ Department of Gastroenterology, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan.
⁶ Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan.
⁷ Department of Gastroenterology, Takamatsu Red Cross Hospital, Takamatsu, Japan.
⁸ Department of Hepatology, Japanese Red Cross Ise Hospital, Ise, Japan.
⁹ Department of Gastroenterology, Japanese Red Cross Asahikawa Hospital, Asahikawa, Japan.
¹⁰ Department of Gastroenterology, Nagano Red Cross Hospital, Nagano, Japan.
¹¹ Department of Gastroenterology, Matsue Red Cross Hospital, Matsue, Japan.
¹² Department of Hepatology, Japanese Red Cross Fukuoka Hospital, Fukuoka, Japan.
¹³ Department of Internal Medicine, Japanese Red Cross Haramachi Hospital, Haramachi, Japan.
¹⁴ Department of Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan.
¹⁵ Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.
¹⁶ Department of Gastroenterology, Takatsuki Red Cross Hospital, Takatsuki, Osaka, Japan.
¹⁷ Department of Hepatology, Japanese Red Cross Okayama Hospital, Okayama, Japan.
¹⁸ Department of Internal Medicine, Tottori Red Cross Hospital, Tottori, Japan.
¹⁹ Department of Gastroenterology, Japanese Red Cross Otsu Hospital, Otsu, Japan.
²⁰ Department of Gastroenterology, Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan.
²¹ Department of Internal Medicine, Karatsu Red Cross Hospital, Karatsu, Japan.
²² Department of Gastroenterology, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan.
²³ Department of Gastroenterology, Shizuoka Red Cross Hospital, Shizuoka, Japan.
²⁴ Department of Gastroenterology, Japanese Red Cross Maebashi Hospital, Maebashi, Japan.

PMID: 30171740
DOI: 10.1111/hepr.13246

Abstract

Aim: This study aimed to describe the real-world efficacy and safety of sofosbuvir (SOF) + ribavirin (RBV) for chronic hepatitis C, genotype 2.

Methods: This was a retrospective analysis of a nationwide, multicenter registry including 914 hepatitis C genotype 2 Japanese patients treated with SOF + RBV for 12 weeks. The rate of sustained virologic response at 12 weeks after treatment (SVR12), incidence of adverse events, and changes in serological parameters were analyzed.

Results: Treatment was completed in 98.9% of patients. Ribavirin dose reduction was required in 29.7% of patients. The SVR12 rate was 96.8% in the intention-to-treat population and 97.6% in the per-protocol population. Factors associated with SVR12 were absence of advanced fibrosis (odds ratio, 5.76, P = 0.003) and interferon-treatment-naïve status (odds ratio, 4.79, P = 0.017). Dose reduction or total adherence of RBV was not associated with SVR. The resistance-associated substitution S282 T in NS5B was not detected in any patient at virologic failure. Serum albumin levels significantly increased, and the degree of increase was greater in patients with advanced fibrosis than in those without (0.21 ± 0.32 vs. 0.05 ± 0.29, P < 0.0001). Alpha-fetoprotein decreased significantly at end of treatment (P < 0.0001), and the degree of decrease was greater in patients with advanced fibrosis than in those without (21.7 ± 60.8 vs. 2.5 ± 15.5, P < 0.001). The most commonly reported adverse event was anemia (13.7%).

Conclusions: Treatment with SOF + RBV was highly effective and safe in Japanese patients with HCV genotype 2 infection.

Keywords: alpha-fetoprotein; chronic hepatitis C; sofosbuvir.