Effect of treatment periods on efficacy of glecaprevir and pibrentasvir in chronic hepatitis C: A nationwide, prospective, multicenter study

Author:

Morita Atsuhiro1,Tamaki Nobuharu2,Kobashi Haruhiko3,Mori Nami4,Tsuji Keiji4,Takaki Shintaro4,Hasebe Chitomi5,Akahane Takehiro6,Ochi Hironori7,Mashiba Toshie7,Urawa Naohito8,Fujii Hideki9,Mitsuda Akeri10,Kondo Masahiko11,Ogawa Chikara12,Uchida Yasushi13,Narita Ryoichi14,Marusawa Hiroyuki15,Kubotsu Yoshihito16,Matsushita Tomomichi17,Shigeno Masaya18,Yoshida Hideo19,Tanaka Katsuaki20,Okamoto Eisuke21,Kasai Toyotaka22,Ishii Toru23,Okada Kazuhiko24,Kurosaki Masayuki2,Izumi Namiki2

Affiliation:

1. Department of Gastroenterology Japanese Red Cross Kyoto Daini Hospital Kyoto Japan

2. Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan

3. Department of Gastroenterology Japanese Red Cross Okayama Hospital Okayama Japan

4. Department of Gastroenterology Hiroshima Red Cross Hospital & Atomic‐bomb Survivors Hospital Hiroshima Japan

5. Department of Gastroenterology Japanese Red Cross Asahikawa Hospital Asahikawa Japan

6. Department of Gastroenterology Ishinomaki Red Cross Hospital Ishinomaki Japan

7. Center for Liver‐Biliary‐Pancreatic Disease Matsuyama Red Cross Hospital Matsuyama Japan

8. Department of Gastroenterology and Hepatology Ise Red Cross Hospital Ise Japan

9. Department of Gastroenterology Japanese Red Cross Kyoto Daiichi Hospital Kyoto Japan

10. Department of Gastroenterology Tottori Red Cross Hospital Tottori Japan

11. Department of Gastroenterology Otsu Red Cross Hospital Otsu Japan

12. Department of Gastroenterology and Hepatology Takamatsu Red Cross Hospital Takamatsu Japan

13. Department of Gastroenterology Matsue Red Cross Hospital Matsue Japan

14. Department of Gastroenterology Oita Red Cross Hospital Oita Japan

15. Department of Gastroenterology and Hepatology Osaka Red Cross Hospital Osaka Japan

16. Department of Internal Medicine Karatsu Red Cross Hospital Saga Japan

17. Department of Gastroenterology Japanese Red Cross Gifu Hospital Gifu Japan

18. Department of Gastroenterology Japanese Red Cross Nagasaki Genbaku Hospital Nagasaki Japan

19. Department of Gastroenterology Japanese Red Cross Medical Center Tokyo Japan

20. Department of Gastroenterology Hatano Red Cross Hospital Hatano Japan

21. Department of Gastroenterology Masuda Red Cross Hospital Masuda Japan

22. Department of Gastroenterology Fukaya Red Cross Hospital Saitama Japan

23. Department of Gastroenterology Japanese Red Cross Akita Hospital Akita Japan

24. Department of Gastroenterology Toyama Red Cross Hospital Toyama Japan

Abstract

AbstractBackground and aimIn patients with chronic hepatitis C, 8 weeks of glecaprevir and pibrentasvir (GLE/PIB) treatment for chronic hepatitis (non‐cirrhosis) and 12 weeks for cirrhosis have been approved in Japan. However, whether 8 weeks of treatment for cirrhosis may reduce treatment efficacy has not been adequately investigated.MethodsThis prospective, nationwide, multicenter cohort study enrolled 1275 patients with chronic hepatitis C who received GLE/PIB therapy. The effect of liver fibrosis and treatment periods on the efficiency of GLE/PIB therapy was investigated. The primary endpoint was the sustained virological response (SVR) rate in patients with chronic hepatitis (non‐cirrhosis) and cirrhosis. The association between treatment periods and liver fibrosis on the SVR after 12 weeks of treatment rate was investigated.ResultsThe SVR rates in patients with chronic hepatitis with 8 weeks of treatment, chronic hepatitis with 12 weeks of treatment, cirrhosis with 8 weeks of treatment, and cirrhosis with 12 weeks of treatment were 98.9% (800/809), 100% (87/87), 100% (166/166), and 99.1% (211/213), respectively, and were was not different among these groups (P = 0.4).ConclusionGLE/PIB therapy for chronic hepatitis C had high efficacy regardless of liver fibrosis status and treatment periods. Periods of GLE/PIB therapy could be chosen with available modalities, and high SVR rates could be achieved regardless of the decision.

Funder

Ministry of Health, Labour and Welfare

Japan Agency for Medical Research and Development

Publisher

Wiley

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