1. Academic Validation
  2. Elevated serum uric acid level was a notable adverse event during combination therapy with sofosbuvir and ribavirin

Elevated serum uric acid level was a notable adverse event during combination therapy with sofosbuvir and ribavirin

  • Hepatol Res. 2018 Feb;48(3):E347-E353. doi: 10.1111/hepr.12971.
Ken Sato 1 2 Atsushi Naganuma 3 Tamon Nagashima 4 Takashi Hoshino 3 Daisuke Uehara 3 Yousuke Arai 4 Katsuhiko Horiuchi 5 Kazuhisa Yuasa 5 Hisashi Takayama 6 Hirotaka Arai 6 Takeshi Hatanaka 3 Tatsuya Ohyama 1 Hiroki Tahara 5 Naondo Sohara 3 Takeshi Kobayashi 1 2 Norio Horiguchi 1 2 Yuichi Yamazaki 1 2 Satoru Kakizaki 1 2 Motoyasu Kusano 7 Masanobu Yamada 1 Takayo Murase 8 Takashi Nakamura 8
Affiliations

Affiliations

  • 1 Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Maebashi, Japan.
  • 2 Department of Hepatology, Heisei Hidaka Clinic, Takasaki, Japan.
  • 3 Department of Gastroenterology, Takasaki General Medical Center, National Hospital Organization, Takasaki, Japan.
  • 4 Department of Gastroenterology, Shibukawa General Medical Center, National Hospital Organization, Shibukawa, Japan.
  • 5 Department of Gastroenterology, Gunma Chuo Hospital, Maebashi, Japan.
  • 6 Department of Gastroenterology, Maebashi Red Cross Hospital, Maebashi, Japan.
  • 7 Department of Endoscopy and Endoscopic Surgery, Gunma University Hospital, Maebashi, Japan.
  • 8 Sanwa Kagaku Kenkyusho Co., Ltd., Inaba, Japan.
Abstract

Aim: Combination therapy with sofosbuvir and ribavirin (SOF/RBV) has been recently available for chronic hepatitis C patients with genotype 2 (CHG2) in Japan. The domestic phase III clinical trial showed a high Antiviral effect with a relatively safe adverse event (AE) profile. Our aim was to report an important AE detected during treatment.

Methods: A prospective multi-institutional study of 12-week combination therapy with SOF/RBV for CHG2 was carried out to evaluate efficacy and safety.

Results: The eligible subjects included 142 patients. Out of 50 assessable patients, 16% of the patients were diagnosed with hyperuricemia. The proportions of subjects with grade 1, grade 3, and grade 4 hyperuricemia were 12, 2, and 2%, respectively. Serum uric acid (UA) levels at week 1 of the therapy (W1) were numerically the highest during therapy in patients with hyperuricemia, and the ratio of W1/baseline serum UA levels was significantly higher than that of post-treatment week 4 or 8/baseline serum UA levels in assessable patients. Serum UA levels at W1 were significantly correlated with body mass index. The difference between serum UA levels at W1 and baseline serum UA levels was significantly correlated with the difference between serum creatinine levels at W1 and baseline serum creatinine levels.

Conclusions: Elevated serum UA level was a notable AE associated with SOF/RBV therapy for CHG2. However, because of the small number of subjects, the exact frequency of AEs should be re-evaluated with larger cohorts. We need to remember that elevated serum UA level might develop during the therapy, especially at W1.

Keywords

chronic hepatitis C; genotype 2; ribavirin; sofosbuvir; uric acid.

Figures
Products
  • Cat. No.
    Product Name
    Description
    Target
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  • HY-15005
    99.97%, HCV 抑制剂
    HCV