Keiji Tsuji1, Masayuki Kurosaki2, Jun Itakura2, Nami Mori1, Shintaro Takaki1, Chitomi Hasebe3, Takehiro Akahane4, Kouji Joko5, Hitoshi Yagisawa6, Jirou Takezawa7, Ryou Nakata8, Atsunori Kusakabe9, Yuji Kojima10, Hiroyuki Kimura11, Takashi Tamada12, Haruhiko Kobashi13, Akeri Mitsuda14, Masahiko Kondou15, Chikara Ogawa16, Yasushi Uchida17, Tetsuro Sohda18, Ryouichi Narita19, Namiki Izumi20. 1. Department of Gastroenterology, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima, Hiroshima, Japan. 2. Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, 1-26-1 Kyonan-cho, Musashino-shi, Tokyo, 180-8610, Japan. 3. Department of Gastroenterology, Japanese Red Cross Asahikawa Hospital, Asahikawa, Hokkaido, Japan. 4. Department of Gastroenterology, Japanese Red Cross Ishinomaki Hospital, Ishinomaki, Miyagi, Japan. 5. Center for Liver-Biliary-Pancreatic Disease, Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan. 6. Department of Gastroenterology, Japanese Red Cross Akita Hospital, Akita, Akita, Japan. 7. Department of Internal Medicine, Japanese Red Cross Haramachi Hospital, Haramachi, Gunma, Japan. 8. Department of Gastroenterology, Japanese Red Cross Medical Center, Shibuya-ku, Tokyo, Japan. 9. Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Aichi, Japan. 10. Department of Hepatology, Japanese Red Cross Ise Hospital, Ise, Mie, Japan. 11. Department of Gastroenterology, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan. 12. Department of Gastroenterology, Takatsuki Red Cross Hospital, Takatsuki, Osaka, Japan. 13. Department of Gastroenterology, Japanese Red Cross Okayama Hospital, Okayama, Okayama, Japan. 14. Department of Gastroenterology, Japanese Red Cross Tottori Hospital, Tottori, Tottori, Japan. 15. Department of Gastroenterology, Japanese Red Cross Otsu Hospital, Otsu, Shiga, Japan. 16. Department of Gastroenterology, Takamatsu Red Cross Hospital, Takamatsu, Kagawa, Japan. 17. Department of Gastroenterology, Matsue Red Cross Hospital, Matsue, Shimane, Japan. 18. Department of Hepatology, Japanese Red Cross Fukuoka Hospital, Fukuoka, Fukuoka, Japan. 19. Department of Gastroenterology, Oita Red Cross Hospital, Oita, Oita, Japan. 20. Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, 1-26-1 Kyonan-cho, Musashino-shi, Tokyo, 180-8610, Japan. izumi012@musashino.jrc.or.jp.
Abstract
BACKGROUND: We aimed to describe the real-world efficacy and safety of combination therapy with ledipasvir and sofosbuvir (LDV/SOF) for chronic hepatitis C virus (HCV) genotype 1 (GT1) infection. METHODS: This retrospective analysis of a prospective, nationwide, multicenter registry included GT1-infected patients treated with LDV/SOF for 12 weeks. We assessed the rate of sustained virological response at 12 weeks post-treatment (SVR12), incidence of adverse events, and serum markers of hepatocellular carcinoma (HCC). RESULTS: Among the 1461 patients included (mean age, 69 years; 29.5% aged > 75 years; cirrhosis, 23.8%; history of treatment for HCC, 10.9%), the overall SVR12 rate was 98.4% (1438/1461). Factors associated with treatment failure were cirrhosis (odds ratio, 4.19; p = 0.014) and resistance-associated substitutions (RASs) in NS5A at baseline (odds ratio, 7.78; p = 0.0004). The SVR12 rate in patients with cirrhosis and NS5A RASs was 93.0% compared to 100% in patients without cirrhosis or NS5A RASs. In patients with SVR, the levels of alpha-fetoprotein (AFP), AFP-L3, and Mac-2 binding protein glycosylation isomer (M2BPGi) decreased from baseline to end of treatment (from 13.4 ± 37.6 to 6.0 ± 10.6 ng/mL, p < 0.0001; from 2.2 ± 4.9 to 1.5 ± 6.3%, p < 0.005; and from 3.6 ± 3.7 to 2.0 ± 3.5 cut-off index, p < 0.0001; respectively). Adverse events were rare and not associated with age. No decrease in estimated glomerular filtration rate was observed in patients with baseline chronic kidney disease stage 3. CONCLUSIONS: LDV/SOF therapy is highly effective and safe in elderly Japanese patients with HCV GT1, even in the presence of cirrhosis or NS5A RASs. Patients with SVR may have a lower risk of HCC.
BACKGROUND: We aimed to describe the real-world efficacy and safety of combination therapy with ledipasvir and sofosbuvir (LDV/SOF) for chronic hepatitis C virus (HCV) genotype 1 (GT1) infection. METHODS: This retrospective analysis of a prospective, nationwide, multicenter registry included GT1-infected patients treated with LDV/SOF for 12 weeks. We assessed the rate of sustained virological response at 12 weeks post-treatment (SVR12), incidence of adverse events, and serum markers of hepatocellular carcinoma (HCC). RESULTS: Among the 1461 patients included (mean age, 69 years; 29.5% aged > 75 years; cirrhosis, 23.8%; history of treatment for HCC, 10.9%), the overall SVR12 rate was 98.4% (1438/1461). Factors associated with treatment failure were cirrhosis (odds ratio, 4.19; p = 0.014) and resistance-associated substitutions (RASs) in NS5A at baseline (odds ratio, 7.78; p = 0.0004). The SVR12 rate in patients with cirrhosis and NS5A RASs was 93.0% compared to 100% in patients without cirrhosis or NS5A RASs. In patients with SVR, the levels of alpha-fetoprotein (AFP), AFP-L3, and Mac-2 binding protein glycosylation isomer (M2BPGi) decreased from baseline to end of treatment (from 13.4 ± 37.6 to 6.0 ± 10.6 ng/mL, p < 0.0001; from 2.2 ± 4.9 to 1.5 ± 6.3%, p < 0.005; and from 3.6 ± 3.7 to 2.0 ± 3.5 cut-off index, p < 0.0001; respectively). Adverse events were rare and not associated with age. No decrease in estimated glomerular filtration rate was observed in patients with baseline chronic kidney disease stage 3. CONCLUSIONS: LDV/SOF therapy is highly effective and safe in elderly Japanese patients with HCV GT1, even in the presence of cirrhosis or NS5A RASs. Patients with SVR may have a lower risk of HCC.
Authors: K Kiyosawa; T Sodeyama; E Tanaka; Y Gibo; K Yoshizawa; Y Nakano; S Furuta; Y Akahane; K Nishioka; R H Purcell Journal: Hepatology Date: 1990-10 Impact factor: 17.425
Authors: Kelvin Nguyen; Melissa Jimenez; Nima Moghadam; Crystal Wu; Alex Farid; Jonathan Grotts; David Elashoff; Gina Choi; Francisco A Durazo; Mohamed M El-Kabany; Steven-Huy B Han; Sammy Saab Journal: J Clin Transl Hepatol Date: 2017-03-08
Authors: Massimo Giuseppe Colombo; Erkin Isakovich Musabaev; Umed Yusupovich Ismailov; Igor A Zaytsev; Alexander V Nersesov; Igor Anatoliyevich Anastasiy; Igor Alexandrovich Karpov; Olga A Golubovska; Kulpash S Kaliaskarova; Ravishankar Ac; Sanjay Hadigal Journal: World J Gastroenterol Date: 2019-08-07 Impact factor: 5.742