Linerixibat dose-response analysis of C4 concentrations as a quantitative approach to predict gastrointestinal tolerability

ABSTRACT

Background and aims: Liver injury is common in patients with coronavirus disease-2019 (COVID-19) infection. Recently, few studies have reported the development of autoimmune hepatitis (AIH) following COVID-19 vaccination. However, there is a lack of studies reporting the outcomes of AIH following ChAdOx1 (vector-based) and BBV152 (inactivated virus) from India. Herewe aimed to describe the clinical profile of patients who developed AIH following COVID-19 vaccination. The causal association is attributed based on the temporal relationship in patients with no prior liver diseases. Method: Patients presenting with deranged liver functions following COVID-19 vaccination to hepatology clinic were included. Virus infections were ruled out in all patients either by serology or viral quantification methods. We aimed to assess the demographics, clinical profile, and outcome of patients with vaccine-induced AIH (V-AIH) in the absence of known liver disease. Results: A total of 31 patients presented with altered liver chemistries following vaccination. Seventeen patients were diagnosed with VAIH (age-39.8 ± 11.4 years;males-70.4%). None of the patient had history of alcohol overconsumption. Seventy six percent of patients had received ChAdOx1 and 23.53% had received BBV152 vaccine (Table). Seventy six percent of patients following first dose of vaccine and 23.5% following second dose of vaccinewere diagnosed as V-AIH. Mean duration for development of symptoms after first dosewas 25.7 days. Common symptom at presentation was jaundice in 82.3% of patients. Antinuclear antibodywas positive in 71% of patients and 17% patients were negative for all serological markers of autoimmune hepatitis but had elevated IgG levels. Fifty-nine percent of patients required immunosuppression of which 41% percet of patients received oral steroids, 17% patients received intravenous steroids for 3 days followed by oral steroid, 12% patients received azathioprine. One patient succumbed to pneumonia with multiorgan failure by day 30. At 3 months, it was observed that only 17% patients needed prolonged immunosuppression and had deranged liver functions until last follow-up. Mean duration of recovery amongst rest of 76.4% patients was 5.15 ± 3.1 weeks.