Safety and effectiveness of SARS‐CoV‐2 vaccines for patients with intractable hepatobiliary diseases: A multicenter, questionnaire‐based, cross‐sectional study

Author:

Tanifuji Ayaka1,Ohfuji Satoko2ORCID,Matsumoto Kosuke1,Abe Masanori3,Komori Atsumasa4ORCID,Takahashi Atsushi5ORCID,Kawata Kazuhito6ORCID,Sato Ken7,Joshita Satoru8ORCID,Umemura Takeji8ORCID,Ueno Masayuki910ORCID,Nakayama Nobuaki11ORCID,Kakisaka Keisuke12ORCID,Arinaga‐Hino Teruko13ORCID,Ito Koichi14,Kanai Sachiko15,Miura Ryo1,Arizumi Toshihiko1,Asaoka Yoshinari1ORCID,Ito Takanori16,Shimizu Tetsuya17,Yoshida Hiroshi17,Ohta Masayuki18ORCID,Mizuno Suguru11,Isayama Hiroyuki14,Morimoto Youichi9,Mochida Satoshi11,Ohira Hiromasa5,Tanaka Atsushi1ORCID

Affiliation:

1. Department of Medicine Teikyo University School of Medicine Tokyo Japan

2. Department of Public Health Osaka Metropolitan University Graduate School of Medicine Osaka Japan

3. Department of Gastroenterology and Metabology Ehime University Graduate School of Medicine Ehime Japan

4. Clinical Research Center National Hospital Organization (NHO) Nagasaki Medical Center Nagasaki Japan

5. Department of Gastroenterology Fukushima Medical University School of Medicine Fukushima Japan

6. Hepatology Division Department of Internal Medicine II Hamamatsu University School of Medicine Shizuoka Japan

7. Department of Gastroenterology and Hepatology Gunma University Graduate School of Medicine Gunma Japan

8. Division of Hepatology and Gastroenterology Department of Medicine Shinshu University School of Medicine Nagano Japan

9. Department of Gastroenterology and Hepatology Kurashiki Central Hospital Okayama Japan

10. Department of Gastroenterology and Hepatology Kyoto University Graduate School of Medicine Kyoto Japan

11. Department of Gastroenterology and Hepatology Faculty of Medicine Saitama Medical University Saitama Japan

12. Division of Hepatology Department of Internal Medicine Iwate Medical University Iwate Japan

13. Division of Gastroenterology Department of Medicine Kurume University School of Medicine Fukuoka Japan

14. Department of Gastroenterology Graduate School of Medicine Juntendo University Tokyo Japan

15. Department of Gastroenterology Graduate School of Medicine The University of Tokyo Tokyo Japan

16. Department of Gastroenterology and Hepatology Nagoya University Graduate School of Medicine Aichi Japan

17. Department of Gastrointestinal and Hepato‐Biliary‐Pancreatic Surgery Nippon Medical School Tokyo Japan

18. Research Center for GLOBAL and LOCAL Infectious Diseases Oita University Oita Japan

Abstract

AbstractAimThere are few data regarding the safety and effectiveness of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) vaccines in patients with intractable hepatobiliary diseases. We conducted a multicenter, questionnaire‐based, cross‐sectional study to determine the safety and effectiveness of the SARS‐CoV‐2 vaccines in Japanese patients with intractable hepatobiliary disease.MethodsPatients aged ≥18 years with autoimmune hepatitis (AIH), primary biliary cholangitis, primary sclerosing cholangitis, Budd–Chiari syndrome, idiopathic portal hypertension, and extrahepatic portal vein obstruction at each center were consecutively invited to join the study. Participants were asked to complete a questionnaire regarding their characteristics, vaccination status, post‐vaccination adverse effects, and SARS‐CoV‐2 infection. Additionally, liver disease status, treatment regimens, and liver function test values pre‐ and post‐vaccination were collected.ResultsThe survey was conducted from September 2021 to May 2022, and 528 patients (220 AIH, 251 primary biliary cholangitis, 6 AIH– primary biliary cholangitis/primary sclerosing cholangitis overlap, 39 primary sclerosing cholangitis, 4 Budd–Chiari syndrome, 5 idiopathic portal hypertension, and 3 extrahepatic portal vein obstruction) participated in the study. Post‐vaccination adverse effects were comparable to those observed in the general population. Post‐vaccination liver injuries classified as grade 1 or higher were observed in 83 cases (16%), whereas grades 2 and 3 were observed in only six cases (1.1%); AIH‐like liver injury requiring treatment was not observed. Overall, 12 patients (2.3%) were infected with SARS‐CoV‐2, and only one patient was infected 6 months after the second vaccination.ConclusionSARS‐CoV‐2 vaccines demonstrated satisfactory safety and effectiveness in Japanese patients with intractable hepatobiliary diseases.

Publisher

Wiley

Reference32 articles.

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5. Immune Dysfunction and Infections in Patients With Cirrhosis

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