COVID-19 Vaccination in Liver Cirrhosis: Safety and Immune and Clinical Responses

Inês Canha, Mário Jorge Silva, Maria Azevedo Silva, Mara Sarmento Costa, Rita Ornelas Saraiva, André Ruge, Mariana Verdelho Machado, Catarina Sousa Félix, Bárbara Morão, Pedro Narra Figueiredo, Milena Mendes, Carina Leal, F. Calinas
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Abstract

Introduction: Three years after the beginning of the SARS-CoV-2 pandemic, the safety and efficacy of COVID-19 vaccination in liver cirrhosis (LC) patients remain controversial. We aimed to study the safety, immunological, and clinical responses of LC patients to COVID-19 vaccination. Methods: Prospective multicentric study in adults with LC eligible for COVID-19 vaccination, without prior known infection. Patients were followed up until the timing of a booster dose, SARS-CoV-2 infection, or death. Spike-protein immunoglobulin G antibody titers for SARS-CoV-2 at 2 weeks, 3 months, and 6 months postvaccination were assessed. Antibody titers <33.8 binding antibody units (BAU)/mL were considered seronegative and <200 BAU/mL suboptimal. Postvaccination infection and its severity were registered. Results: We included 124 LC patients, 81% males, mean aged 61 ± 10 years, with a mean follow-up of 221 ± 26 days. Alcohol was the most common (61%) cause of cirrhosis, and 7% were under immunosuppressants for autoimmune hepatitis; 69% had portal hypertension, 42% had a previous decompensation, and 21% had a Child-Pugh-Turcotte score of B/C. The type of vaccine administrated was BNT162b2 (n = 59, 48%), ChAdOx1nCoV-19 (n = 45, 36%), mRNA-1273 (n = 14, 11%), and Ad26.COV2.S (n = 6, 5%). Eighteen percent of the patients reported adverse events after vaccination, none serious. Median [Q1; Q3] antibody titers were 1,185 [280; 2,080] BAU/mL at 2 weeks, 301 [72; 1,175] BAU/mL at 3 months, and 192 [49; 656] BAU/mL at 6 months. There were seronegative and suboptimal antibody responses in 8% and 23% of the patients at 2 weeks, 16% and 38% at 3 months, and 22% and 48% at 6 months. Older age and adenovirus vector vaccines were the only factors associated with seronegative and suboptimal responses at 2 weeks and 3 months (p < 0.05) in a multivariable logistic regression analysis. Eleven patients (9%) were infected with SARS-CoV-2 during follow-up (3.8–6.6 months postvaccination), all with mild disease. There were no differences regarding the type of vaccine, and 73% had antibody titers >200 BAU/mL at 3 months. Conclusion: COVID-19 vaccines in patients with LC were safe, without serious adverse events. The humoral and clinical responses were similar to the reported for the general population. Humoral response was adversely impacted by older age and adenovirus vector vaccines and unrelated to the liver disease severity.
肝硬化患者接种 COVID-19 疫苗:安全性、免疫和临床反应
导言:在 SARS-CoV-2 大流行开始三年后,肝硬化(LC)患者接种 COVID-19 疫苗的安全性和有效性仍存在争议。我们旨在研究肝硬化患者接种 COVID-19 疫苗的安全性、免疫学和临床反应。研究方法前瞻性多中心研究,对象为符合接种 COVID-19 疫苗条件的成人肝硬化患者,既往未发现感染。对患者进行随访,直至其接种加强剂、感染 SARS-CoV-2 或死亡。评估接种后 2 周、3 个月和 6 个月的 SARS-CoV-2 免疫球蛋白 G 抗体滴度。3 个月时抗体滴度为 200 BAU/mL。结论对 LC 患者接种 COVID-19 疫苗是安全的,没有出现严重的不良反应。体液反应和临床反应与普通人群的报告相似。体液反应受年龄和腺病毒载体疫苗的不利影响,与肝病严重程度无关。
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