ABSTRACT
Introduction: Liver injury is frequently seen in coronavirus disease 2019 (COVID-19), and it has been reported to be associated with the severity of COVID-19. The direct action of the virus, cytokine storm, coagulation abnormalities, drug-induced, etc. are considered to be the causes of liver injury, and antiviral agents against COVID-19 and steroids used as anti-inflammatory agents have also been reported to contribute to the appearance of liver injury. In Japan, remdesivir, dexamethasone (Dex), baricitinib, etc. are used as therapeutic agents for COVID-19, but there is still not enough evidence about the frequency of liver injury as an adverse event. Aims & Methods: This study aimed to clarify the influence of Dex monotherapy for liver injury in COVID-19 with respiratory failure. We examined 171 patients with COVID-19 with liver injury in the respiratory failure groups and the nonrespiratory failure groups and investigated 41 patients with moderate COVID-19 with respiratory failure who received Dex monotherapy in the liver injury group and the nonliver injury group at the time before treatment. Result(s): The respiratory failure group had 64% more liver damage than the non-respiratory failure group, was older, had more men, and had significantly more complications of lifestyle-related diseases such as hypertension and diabetes. Obesity was more common in the liver injury group prior to Dex monotherapy, and the liver CT value was significantly lower than in the non-liver injury group. Liver injury worsened in 41% of patients after Dex monotherapy, but there was no significant difference in the frequency before Dex monotherapy between the liver injury group and the non-liver injury group, and the degree of liver injury was mild in all cases, improving in 38% of the liver injury group. Conclusion(s): Dex monotherapy was a safe treatment for moderate COVID-19 with respiratory failure, which frequently resulted in liver injury.
ABSTRACT
Purpose: The efficacy and safety of SARS-CoV-2 vaccination have been confirmed in several clinical trials. However, patients with autoimmune liver disease were not subject to clinical trials, and data on the efficacy and safety of vaccines have been not available in these population. Therefore, we retrospectively investigated the safety and effectiveness of SARS-CoV-2 vaccination by questionnaire survey targeting Japanese patients with autoimmune hepatitis (AIH) and primary biliary cholangitis (PBC). Method(s): This is a multi-center, retrospective, cross-sectional, questionnaires-based study. Patients with AIH and PBC who are outpatients at participating facilities, 18 years of age or older, and have given consent to participate in this study are included. We distributed questionnaires asking about sex, date of birth, number and type of vaccinations, the presence and degree of adverse effects (AEs), and the presence or absence of SARS-CoV-2 infection before and after vaccination, and asked them to fill in the questionnaire. In addition, we collected the result of liver tests before and after vaccinations of participating patients from each facility. Result(s): The survey was conducted from September 2021 to May 2022. A total of 471 questionnaires were collected from 220 AIH patients (male/female = 33/187, average age 63.5 +/- 13.1 years old) and 251 PBC patients (38/213, 65.8 +/- 10.1). The number of vaccinations was 0/1/2/unknown = 4/0/210/6 for AIH and 4/2/244/1 for PBC. The median time from the second dose to the completion of the questionnaire was 156 days for AIH and 148 days for PBC. By vaccine type, 193 Pfizer, 11 Moderna, and 16 unknown in AIH, and 223/12/16 in PBC. As for AEs, pain and swelling at the injection site were the most common in both AIH and PBC (75% in the first and 64% in the second in AIH, 64%/61% in PBC), followed by general malaise (19%/21% in AIH, 19%/31% in PBC), and myalgia (16%/ 19% in AIH, 19%/14% in PBC). Fever above 38.5 degreeC was observed in 11%/11% of AIH and 11%/24% of PBC, indicating that more patients with PBC experiencing fever that AIH. Only 1 case of PBC had an anaphylactic reaction. By comparing liver tests before and after vaccinations, 4 (1.8%) and 16 (6.4%) patients with AIH and PBC, respectively, demonstrated elevation to 1.5 times the pre-vaccination value and exceeding the upper normal limit. No patients experienced severe deterioration of liver function. SARS-CoV-2 infection was reported in 4 cases (1.8%) in AIH and 3 cases (1.3%) in PBC. Conclusion(s): The safety and effectiveness of SARS-CoV-2 vaccination is comparable to those in the general population.