Department of Hepatology, Post-Graduate Institute of Medical Education and Research, Chandigarh, India.
Department of Virology, Post-Graduate Institute of Medical Education and Research, Chandigarh, India.
Dig Dis Sci. 2023 Feb;68(2):676-684. doi: 10.1007/s10620-022-07641-2. Epub 2022 Sep 25.
Patients with cirrhosis have a higher risk of severe COVID-19 and mortality and are high-priority patients for vaccination. However, cirrhotics were excluded from the phase 2/3 vaccine trials. Hence, we aimed to assess the antibody response and safety of Covishield (ChAdOx1nCoV-19) among patients with cirrhosis.
Patients who attended the tele-hepatology services at our institute from March 2020 to June 2021 and diagnosed with cirrhosis as per their medical records were telephonically interviewed in July 2021 using a pre-specified questionnaire. Patients who had completed 2 doses of ChAdOx1-nCOV (with the 2 dose administered at least 2 weeks back) and without history of documented COVID-19 infection (pre- or post-vaccination) were tested for antibodies against the spike protein. Seropositive patients were divided into high, moderate, and low antibody responses based on the signal/cut-off.
We interviewed 784 patients with cirrhosis. At least 1 dose of ChAdOx1-nCOV was received by 231 patients among whom 134 (58%) had received 2 doses. Documented COVID-19 was reported in 3.9% patients who received at least 1 dose of ChAdOx1-nCOV including breakthrough infections in 3.7% patients vaccinated with 2 doses. Local and systemic adverse events were reported by 42% and 22.1% patients. None developed anaphylaxis, acute decompensation, acute-on-chronic liver failure, or other serious adverse events requiring hospitalization. Seroconversion was documented in 81 (92%) out of 88 patients. No difference was observed in level of antibody response between patients with compensated and decompensated cirrhosis (p = 0.12).
Our preliminary data suggest that ChAdOx1-nCOV is safe with high seroconversion rates in patients with cirrhosis.
患有肝硬化的患者患严重 COVID-19 和死亡的风险更高，因此是疫苗接种的重点人群。然而，在 2/3 期疫苗试验中排除了肝硬化患者。因此，我们旨在评估 Covishield（ChAdOx1nCoV-19）在肝硬化患者中的抗体反应和安全性。
我们于 2020 年 3 月至 2021 年 6 月期间通过远程肝病服务，对我院的肝硬化患者进行了电话采访，采访使用了预先确定的问卷，采访时间为 2021 年 7 月。患者完成了 2 剂 ChAdOx1-nCOV（至少 2 周前接种了第 2 剂）且无记录的 COVID-19 感染（接种前或接种后）史，对针对刺突蛋白的抗体进行了检测。根据信号/截止值，将血清阳性患者分为高、中、低抗体反应。
我们采访了 784 名肝硬化患者。其中，231 名患者至少接种了 1 剂 ChAdOx1-nCOV，其中 134 名（58%）接种了 2 剂。至少接种了 1 剂 ChAdOx1-nCOV 的患者中有 3.9%报告了 COVID-19，其中 3.7%接种了 2 剂的患者发生了突破性感染。42%和 22.1%的患者报告了局部和全身不良事件。无发生过敏反应、代偿失调恶化、慢加急性肝衰竭或其他需要住院治疗的严重不良事件的报道。88 名患者中的 81 名（92%）记录到了血清转化率。在代偿失调和失代偿失调的肝硬化患者之间，抗体反应水平没有差异（p=0.12）。
我们的初步数据表明，ChAdOx1-nCOV 在肝硬化患者中是安全的，具有较高的血清转化率。
