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1.
Hum Vaccin Immunother ; : 2136435, 2022 Oct 26.
Article in English | MEDLINE | ID: covidwho-2087654

ABSTRACT

Studies have shown that patients with chronic liver disease are at a higher risk of contracting novel coronavirus pneumonia than healthy individuals, and many guidelines state that patients with chronic liver disease should be prioritized for COVID-19 vaccination, but there are a few studies on its safety in CLD patients. We aimed to evaluate the safety of the inactivated COVID-19 vaccine in patients with chronic liver disease, and the effect of anxiety on adverse reactions. A questionnaire survey for self-administered post-vaccination adverse reaction monitoring was conducted from June 17, 2021, to August 11, 2021, in patients with chronic liver disease attending a tertiary care hospital in Taizhou, China. We analyzed the data from of a total of 160 participants who scanned the QR code on social media to respond to the questionnaire. The overall incidence of adverse reactions after COVID-19 vaccination in patients with chronic liver disease was 44.4% (71/160), and the most common adverse reaction was local injection site reaction, accounting for 80.3% of adverse reactions (57/71). No serious adverse reactions were reported. Approximately 53.1% of the patients had anxiety about vaccination, and 51.8% of those who felt anxious reported adverse reactions. The safety of COVID-19 vaccination in patients with chronic liver disease is good, and there is a strong association between adverse reactions and vaccine anxiety. Pre-vaccination education for patients with vaccine anxiety and psychological counseling may reduce reports of adverse reactions and improve patients' confidence in the vaccine.

3.
Front Immunol ; 13: 988004, 2022.
Article in English | MEDLINE | ID: covidwho-2080152

ABSTRACT

The antibody and B cell responses after inactivated SARS-CoV-2 vaccination have not been well documented in patients with autoimmune liver disease (AILD). Therefore, we conducted a prospective observational study that included AILD patients and healthy participants as controls between July 1, 2021, and September 30, 2021, at the Second Affiliated Hospital of Chongqing Medical University. All adverse events (AEs) after the COVID-19 vaccination were recorded and graded. Immunoglobulin (Ig)-G antibodies against the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein (anti-RBD-IgG) and neutralizicadng antibodies (NAbs) were tested following full-course vaccination (BBIBP-CorV or CoronaVac). In addition, SARS-CoV-2-specific B cells were detected by flow cytometry. In total, 76 AILD patients and 136 healthy controls (HCs) were included. All AEs were mild and self-limiting, and the incidences were similar between the AILD and HCs. The seropositivity rates of anti-RBD-IgG and NAbs in AILD were 97.4% (100% in HCs, p = 0.13) and 63.2% (84.6% in HCs, p < 0.001), respectively. The titers of anti-RBD-IgG and NAbs were significantly lower in AILD patients than those in HCs. After adjusting for confounders, immunosuppressive therapy was an independent risk factor for low-level anti-RBD-IgG (adjusted odds ratio [aOR]: 4.7; 95% confidence interval [CI], 1.5-15.2; p = 0.01) and a reduced probability of NAbs seropositivity (aOR, 3.0; 95% CI, 1.0-8.9; p = 0.04) in AILD patients. However, regardless of immunosuppressants, the SARS-CoV-2-specific memory B cells responses were comparable between the AILD and HC groups. Our results suggest that inactivated SARS-CoV-2 vaccines (BBIBP-CorV and CoronaVac) are safe, but their immunogenicity is compromised in patients with AILD. Moreover, immunosuppressants are significantly associated with poor antibody responses to the SARS-CoV-2 vaccines. These results could inform physicians and policymakers about decisions on screening the populations at higher risk of poor antibody responses to SARS-CoV-2 vaccines and providing additional vaccinations in patients with AILD.


Subject(s)
Autoimmune Diseases , COVID-19 , Liver Diseases , Humans , COVID-19 Vaccines/adverse effects , SARS-CoV-2 , Immunosuppressive Agents/adverse effects , Antibody Formation , Antibodies, Viral , Immunoglobulin G
4.
Journal of Clinical and Experimental Hepatology ; 2022.
Article in English | ScienceDirect | ID: covidwho-2069268

ABSTRACT

Background/Objectives Adherence to medication(s) is an essential component of holistic management in any chronic disease including in post liver transplant patients. Thus, this study aimed to assess adherence to medications in Indian pediatric liver disease patients (including post liver transplant recipients) and to identify variables affecting its occurrence. Methods A cross sectional study was conducted amongst pediatric (<18 years of age) subjects with Wilson disease (WD) and Autoimmune liver disease (AILD) along with post liver transplant (LT) recipients from May 2021 to October 2021. Structured tools using pre-validated questionnaires (‘Medication adherence measure’ (MAM), and the ‘The Child & Adolescent Adherence to Medication Questionnaire’ (CAAMQ) were used to collect data related to non adherence prevalence (based on missed and late doses) and factors influencing the adherence. Results A total of 152 children were included in the study (WD 39.5 %, AILD 32.9 % & Post LT 27.6 %). Prevalence of missed and late dose non adherence (at a cut off of > 20 %) was 12.5 % and 16.4 % respectively. Older age (odd’s ratio/O.R 1.185), stay in a rural area (O.R 5.08), and barriers like ‘bad taste of medication’ (O.R 4.728) and ‘hard to remember the medication’ (O.R 7.180) were independently associated with non adherence (p < 0.05). Conclusions Overall, non adherence was seen in 12 to 16 % i.e. around one-sixth of the patients, with least non adherence seen in post liver transplant recipients (0 to 2.4 %). Older age of the patient, rural place of stay and personal barriers like hard to remember/forgetfulness and bad medication taste were identified as factors independently leading to non adherence.

5.
Middle East Journal of Digestive Diseases ; 14(2):229-234, 2022.
Article in English | ProQuest Central | ID: covidwho-2067666

ABSTRACT

Vitamin D, HOMA-IR, Exercise, Non-alcoholic fatty liver disease INTRODUCTION Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide, defined as fat accumulation, especially triglycerides, in hepatocytes, which are associated with metabolic syndrome, insulin resistance, type 2 diabetes, and cardiovascular disease.1-2 Sedentary lifestyles and poor eating habits are among the main causes of increased insulin resistance and obesity, the two important risk factors for NAFLD.2-3 Different exercise and physical activity cause diverse alterations in insulin resistance and recognizing these changes might affect the interpretation of exerciseinduced mechanisms in patients with NAFLD.4-5 It has been reported that exhaustive eccentric exercise (EEE), along with a positive role in weight loss and physiological adaptation, might lead to cell damage.6 Many studies have reported liver damage and increased insulin resistance following EEE due to the reduced hepatic circulation and subsequent mitochondrial swelling in hepatocytes.7,8 Different approaches (e.g. supplementation) have been considered to neutralize the adverse effects of EEE including increased liver enzymes and muscle damage.9 Among which vitamin D (Vit D ) supplementation plays a significant role in the prevention of NAFLD.10 According to studies, Vit D with anti-fibrosis and anti-inflammatory properties is effective to induce insulin sensitivity by improving liver enzymes and reducing insulin resistance.11,12 To our knowledge, few studies have investigated the EEE-induced glycemic variables responses before and after a short-term Vit D supplementation in patients with NAFLD;thus, we aimed to investigate the effect of short-term Vit D supplementation on glycemic variables alterations in response to EEE in patients with NAFLD. Exclusion criteria were smoking, history of heart or kidney disease, taking lipid-lowering drugs, being infected with coronavirus disease 2019 (COVID-19), Vit D supplementation and regular exercise six months before the start of the study, fundamental diet changes, and failure to follow the study protocol. 26 individuals who met the inclusion criteria were then selected as subjects that were randomly assigned into Exp (n=13) and C (n=13) groups. [...]5 minutes of cooling down at a speed of 3 km/h and a zero slope were performed. Liver enzymes (Alanine transaminase [ALT], Aspartate transaminase [AST], and gamma-glutamyl transferase [GGT]) were measured with the enzymelinked immunosorbent assay (ELISA) method (Greiner Bio-One kit, made in Germany), fasting insulin levels with ELISA method (Mercodia kit, made in Sweden), glucose with enzymatic method (Pars Azmun kit, made in Iran), and the insulin resistance index was also performed using the homeostatic model assessment for insulin resistance (HOMA-IR) (Homeostasis Model Assessment of Insulin Resistance) equation.

6.
Gut ; 71(Suppl 3):A83, 2022.
Article in English | ProQuest Central | ID: covidwho-2064233

ABSTRACT

P69 Table 1Demographic and transplant data for all 14 prioritised patientsPatient/Sex Centre Age at registration (yrs) Primary liver disease Registered prior to Prioritisation Indication of Prioritization LT Waiting time on prioritised tier/Time on list prior to prioritisation 1/M 1 0 CDG Yes Acute decompensation with presence of encephalopathy Yes/LLS 5/27 2/M 2 1 Cryptogenic Cirrhosis Yes CLD with nodular lesions s/o HCC Yes/LLS 16/48 3/F 1 15 AILD Yes Chronic rejection Yes/whole liver 3/4 4/M 2 0 Biliary Atresia Yes PTLD/HAT/Sepsis Yes/LLS 14/71 5/F 2 4 IFALD No Coagulopathy with active bleeding/Renal impairment Yes/LLS 15/820 6/F 2 0 Biliary Atresia Yes Acute decompensation due to portal hypertension Yes/LLS 37/405 7/M 2 10 NSC Yes Decompensated chronic liver disease/Renal impairment Yes/reduced R lobe 4/7 8/M 3 8 PFIC3 Yes Acute decompensation of Chronic liver disease Yes/LLS 6/51 9/F 1 0 Other (Hepatoblastoma) Intestinal Tx prioritized Acute decompensation of Chronic liver disease Yes/LLS 11/ 10/F 2 0 Biliary atresia Yes Decompensated Chronic Liver Disease with Severe Coagulopathy Yes/LLS 10/120 11/M 1 0 Biliary atresia (Hepatoblastoma) Yes Acute decompensation of Chronic liver disease Yes/LLS 9/4 12/F 3 0 Biliary atresia Yes Acute decompensation of Chronic liver disease Yes/LLS 12/323 13/F 1 17 Hepatic Artery thrombosis Yes Hepatic Artery thrombosis Yes/whole liver 2/ 14/F 2 0 Biliary atresia Yes Acute decompensation of Chronic liver disease Suspended 12/65 PFIC3;Progressive Familial Intrahepatic Cholestasis type 3, LT;Liver transplantation, HCC;Hepatocellular Carcinoma NSC;Neonatal Sclerosing Cholangitis, CDG;Congenital Disorder of Glycosylation, AILD;Autoimmune Liver Disease, IFALD;Intestinal Failure Associated Liver Disease,PTLD;Center 1-Kings;Center2-Birmingham;Center3-Leeds.ConclusionThe national paediatric prioritization tier, introduced during the COVID19 pandemic, has been a pivotal initiative for the UK paediatric LT program, showcasing national collaboration. All patients underwent a LT successfully within a short time from prioritization with 100% patient and graft survival. The intention is to maintain this prioritized paediatric tier beyond the pandemic.

7.
Gut ; 71(Suppl 3):A75, 2022.
Article in English | ProQuest Central | ID: covidwho-2064232

ABSTRACT

IntroductionAcute extensive non-malignant non-cirrhotic portomesenteric thrombosis can lead to bowel infarction and frequently does not resolve with anticoagulation. In 2019 we published our first case series of a stepwise thrombolysis protocol involving the use of low dose tissue plasminogen activator (L-tPa) followed, if indicated, by Catheter-Directed Thrombolysis (CDT) and Transjugular Intrahepatic Portosystemic Shunt (TIPSS). We present an updated series, aiming to explore the recanalization rates, symptom resolution and any adverse events for patients who received this protocol.MethodWe retrospectively reviewed the clinical records of patients who received the stepwise regimen at Royal Free Hospital between December 2019 & March 2022.ResultsA total of 35 patients were included with a mean age of 47 (SD=14) years;63% were males. Thrombophilia was identified in 13 (37%) cases and 14 (40%) had other local or systemic causes for thrombosis (1 had COVID-19;3 received ChAdOx1 vaccination). Three patients had underlying chronic liver disease. All patients had ongoing abdominal pain despite anticoagulation. Occlusive portal vein thrombosis (PVT) was found in 30 (86%) patients with 18 (51%) having thrombosis of all three vessels (PVT + splenic vein + superior mesenteric vein). While all patients received L-tPa within a median of 15 (IQR =18) days of symptoms, CDT was applied in 17 (49%) patients and TIPSS was inserted in 15 (43%). CDT was delivered through EKOS™ endovascular system in 11/17 (65%). A degree of recanalization was observed in 24 (69%). TIPSS was patent at discharge in 14/15 (93%).The majority 28 (80%) were maintained on warfarin and 11 had concomitant anti-platelet therapy. Fifteen patients had imaging follow-up available [median duration of 9 (IQR = 11) months]. Recanalization was maintained in 9/15 (60%) and TIPSS remained patent in 6/9 (67%). At a median follow up of 6.5 (IQR = 9) months, complete symptom resolution was achieved in 30/34 (88%).Nine patients underwent bowel resection within a median duration of 11 (IQR= 10.5) days from presentation;mean length of bowel resected was 67 cm (SD = 50). One patient was discharged on parenteral nutrition and had a stoma. One patient died during the initial admission (related to bowel ischemia) and 1 had intracranial haemorrhage. Minor bleeding was recorded in 8 patients.ConclusionOur protocol resulted in good recanalization and patency rates with the majority achieving symptom resolution. While some patients required surgical intervention, bowel continuity was maintained and only one patient had a stoma.

8.
Gut ; 71(Suppl 3):A73, 2022.
Article in English | ProQuest Central | ID: covidwho-2064229

ABSTRACT

P55 Figure 1Patient survival to 90 days in precovid year compared with covid year[Figure omitted. See PDF]DiscussionAlthough the overall mortality of patients presenting with UGIVB to UHNM was high, there was no significant difference in the mortality between the pre-COVID and the COVID year. This finding contrasts with the previously published data from London. Several factors may have contributed to this difference including variations in patient characteristics, availability of endoscopy services during the periods of lockdown and the variations in the overall burden of COVID pandemic on the hospitals in different parts of the country.

9.
Gut ; 71(Suppl 3):A72, 2022.
Article in English | ProQuest Central | ID: covidwho-2064228

ABSTRACT

P54 Figure 1ConclusionUnsurprisingly, there were 1.5 times more fibroscan cases in the pre-covid year (1633 in 2019 compared to 1058 in 2021), indicating the negative impact of COVID-19 in the diagnosis of chronic liver diseases. In addition, NAFLD had a higher rate of advanced fibrosis compared to hepatitis B with the possibility of more sequential HBV follow-up, late referral of NAFLD or impact of fasting state on steatohepatitis.We need to evaluate the interval and indications of repeat fibroscan in each etiology due to no significant variation of LSM value despite different fibroscan intervals. We also need to improve the fibroscan access in district hospitals and other specialities regarding external referral data.

10.
Gut ; 71(Suppl 3):A57-A59, 2022.
Article in English | ProQuest Central | ID: covidwho-2064226

ABSTRACT

P35 Figure 1ConclusionsUnplanned hospital attendances are common amongst cirrhotic patients, particularly those from lower socioeconomic groups. Over half of patients with at least one liver-related admission died during the follow up period, with two thirds of these deaths occurring during or shortly after discharge.The data shows the true burden of liver disease and highlights the need for improved in-patient care for this vulnerable patient group.

11.
Gut ; 71(Suppl 3):A24-A25, 2022.
Article in English | ProQuest Central | ID: covidwho-2064223

ABSTRACT

OP27 Figure 1The authors propose a model, summarised in Figure 1, to integrate palliative and supportive care alongside and within standard hepatology care for patients with end stage liver disease who are ineligible for transplant, in an era where remote and distant review requires innovation to provide care in the right place and at the right time, to safeguard the previous progress made.

12.
Gut ; 71(Suppl 3):A24, 2022.
Article in English | ProQuest Central | ID: covidwho-2064222

ABSTRACT

The COVID-19 pandemic has presented unique challenges. Beyond the direct COVID-related mortality in those with liver disease, we sought to determine the effect of lockdown on people with liver disease in Scotland. The effect of lockdown on those with alcohol-related disease is of interest;and whether there were associated implications for a change in alcohol intake and consequent presentations with decompensated disease.We performed a retrospective analysis of patients admitted to seven Scottish hospitals with a history of liver disease between 1 April and 30 April 2020 (n=111) and compared across the same time in 2017, 2018 and 2019 (n=348). We also repeated an intermediate assessment based on a single centre to examine for delayed effects between 1 April and 31 July 2020 (n=89) compared to the same time period in 2017–2019 (n=284). Information was collected on patient demographics, disease characteristics, length of stay and inpatient mortality.We found that results and outcomes for patients admitted in 2020 were similar to those in previous years in terms of morbidity, mortality, and length of stay. In the Scotland-wide cohort: admission UKELD (United Kingdom Model for End-Stage Liver Disease) (56 (52–60) vs 54 (50–60);p<0.01), inpatient mortality ((10.9% vs 8.6%);p=0.499) and length of stay (8 days (4–15) vs 7 days (4–13);p=0.140). In the single centre cohort: admission UKELD (57 (53–62) vs 57 (53–60);p=0.246), inpatient mortality ((13.7% vs 10.1%;p=0.373) and length of stay (7 days (4–14) vs 7 days (3.5–14);p=0.525)).In the Scotland wide cohort, patients admitted in 2020 had a significantly higher serum sodium at presentation (137 (132–140) vs 135 (130–138) p<0.01)This group also had lower rates of HCC (1.8% vs 7.2%;p=0.04)In the single centre cohort, patients admitted in 2020 had lower rates of hepatic encephalopathy (21.3% vs 35.9%;p=0.01) and were less likely to be admitted due to decompensation (70.8% vs 82.7%;p=0.01). This assessment of immediate and medium-term lockdown impacts on those with chronic liver disease suggested a minimal effect on the presentation of decompensated liver disease to secondary care in terms of patient outcomes.

13.
Gut ; 71(Suppl 3):A20-A21, 2022.
Article in English | ProQuest Central | ID: covidwho-2064220

ABSTRACT

Transjugular intrahepatic portosystemic shunt (TIPSS) is an effective treatment for decompression of portal hypertension and is most commonly indicated in patients with chronic liver disease (CLD) or portal vein thrombosis (PVT). It is a technically challenging intervention. CLD patients are often frail with comorbidities conferring increased procedural risk. We tell the story of one year of procedures at the Royal Free Hospital (RFH), one of the major centres for TIPSS in Europe.A retrospective electronic casenote review was carried out for all patients who underwent TIPSS procedure at the RFH between April 2021 and April 2022. The outcomes of interest were success rate, complications and survival including those who went on to transplantation. A successful procedure was defined as a correctly placed stent with no procedural complications and symptom resolution. Eighty-four (84) patients underwent TIPSS during the 12-month period. Of these, 3 were abandoned: 2 because portal hypertension was absent on direct measurement and 1 due to anatomical infeasibility. Of the 81 completed, the most common indication was diuretic-intolerant ascites (n=32), followed by variceal bleeding (n=27), PVT (n=14), and other indications (n=8). The clinical success rates post-TIPSS for each indication are as follows. For diuretic intolerant ascites, 53.1% (17/32) of patients no longer require large volume paracentesis (LVP), 28.1% (9/21) require LVP at a reduced frequency, 6.3% (2/32) have been transplanted and 1 patient continues to have LVP at the same rate. For variceal bleeding, 85.2% (23/27) of patients have had no further episodes of bleeding. For PVT, 85.7% (12/14) of TIPSS remain patent with no patient requiring surgical intervention. No procedural complications were reported. Overall survival post-TIPSS is 87.7% (71/81) with procedure-related mortality accounting for no deaths. 8 patients who received TIPSS went on to be listed for liver transplant, of those 3 successfully received a graft, 4 remain listed and 1 has died while listed.A high number of TIPSS procedures were performed. The majority were successful with favourable clinical outcomes. Major challenges faced by the service during this time included staff shortages, bed capacity, transfer logistics and the wider impacts of the COVID-19 pandemic. This service depends on the collective expertise and close working of multiple specialties including hepatology, interventional radiology, intensive care and anaesthetics along with logistical and operational support. In an environment where all of these healthcare professionals work together to support the provision of TIPSS, patients can benefit from positive outcomes.

14.
Gut ; 71(Suppl 3):A13-A14, 2022.
Article in English | ProQuest Central | ID: covidwho-2064219

ABSTRACT

OP06 Table 1Demographics of patients Valid (n=) Missing (n=) Mean Std. Deviation Minimum Maximum Age (years) 134 0 55.522 15.111 17 87 Metabolic risk factors BMI in kg/m2 129 5 34.875 7.168 21.5 59.3 HbA1c (mmol/mol) 118 16 47.398 14.793 27 94 Total cholesterol (mmol/L) 119 15 4.646 1.195 1.9 7.4 Triglyceride level (mmol/L) 104 30 2.117 1.211 0.6 7.1 Blood tests AST U/L 116 18 48.621 36.672 14 318 ALT U/L 134 0 61.515 49.304 8 367 Bilirubin umol/L 134 0 11.261 9.398 3 59 Albumin g/L 133 1 44.12 4.624 21 53 Platelet count (x10*9/L) 134 0 229.343 83.631 23 509 INR 98 36 1.052 0.22 0.9 2.5 Fibrosis assessment Enhanced liver fibrosis (ELF) 16 118 9.671 0.754 8.31 11.06 Elastography (kPa) 79 55 10.944 7.049 2.5 39 CAP score 78 56 315.808 59.388 104 400 ConclusionOur study showed that patients with underlying metabolic risk factors were treated in 80% of cases. TE is not performed in all patients due to social isolation limitation imposed by covid-19 infection. In those who had TE;the index diagnosis of cirrhosis was seen in around 20% at the time of TE.

15.
Gut ; 71(Suppl 3):A3, 2022.
Article in English | ProQuest Central | ID: covidwho-2064218

ABSTRACT

The 2013 NCEPOD report ‘Measuring the Units’ reviewed the care of patients who died with alcohol-related liver disease (ArLD) in 2011. It highlighted that the care of patients who died of ArLD was less than good in more than 50% of cases reviewed. Given the ongoing concerns about the variation in outcomes of patients with ArLD, a Survey of the care of patients admitted to hospital with ArLD was commissioned by NCEPOD.All Acute Trusts in England, Wales and Northern Ireland were sent the Survey, which required completion based on Trust data and Lead Gastroenterologist/Hepatologist input. The questions covered numbers of admissions and mortality, alcohol screening and withdrawal management, the presence and constitution of an Alcohol Care Team (ACT), triage of decompensated ArLD patients to Gastroenterology/Hepatology and use of the BSG/BASL chronic liver disease care bundle, as well as escalation of care. In view of the impact of COVID-19, the Survey was sent round to Acute Trusts in January 2021 interrogating information from 2019.ResultsNCEPOD received responses from 145 Acute Trusts including District General Hospitals, regional Liver Units as well as Liver Transplant Units. This included 20,876 ArLD admissions and 2481 deaths in hospital, constituting 11.9% of admissions), with a wide variation in the numbers of reported admissions and deaths between Trusts. The use of symptom-triggered alcohol withdrawal scale (CIWA-Ar) was only 9.9% in the original report, but was employed on specific wards in 88.2% of Trusts in this Survey. The presence of a multidisciplinary ACT increased from 23.2% of Trusts in 2011 to 51.9%, although only 20% of Trusts responding had a Consultant Lead with dedicated sessions. 78% of Trusts stated that they triage patients with decompensated cirrhosis to a Gastroenterologist/Hepatologist and 70% of responding Trusts stated that they used BSG/BASL decompensated chronic liver disease care bundle. The responding clinician reported that it was subjectively more difficult to get patients with decompensated ArLD rather than other forms of cirrhosis into Critical Care in 28.3% of Trusts. Only 23% of ArLD patients who died had coded evidence of palliative care input.ConclusionsThis Survey compares specific aspects of care in patients with ArLD between 2011 and 2019 and indicates that there have been noteworthy improvements in certain areas of care provision, but also points to where attention is required in order to achieve consistent, high-quality care for this patient group, who have a high in-patient mortality.

16.
Gut ; 71(11):2363-2364, 2022.
Article in English | ProQuest Central | ID: covidwho-2064217
17.
Drug Safety ; 45(10):1186, 2022.
Article in English | ProQuest Central | ID: covidwho-2046964

ABSTRACT

Introduction: Remdesivir, has been evaluated in the treatment of SARS-CoV-2 pneumonia in several clinical trials, then it has been used in routine care since the European approval in this indication. Objective: The main objective of the RESPIR'Nantes study was to describe the clinical outcome and safety of patients treated with remdesivir in real life. We chose here to focus on safety outcomes. Methods: To describe the safety, we considered adverse events (AEs), based on those reported to date in the Summary of Product Characteristics and potential post-marketing signals from the inter- national pharmacovigilance database Vigilyze®. AEs were classified according to the System Organ Class (SOC) of the Medical Dic- tionary of Adverse Events terminology. The AEs of SOC "hepatobiliary disorders" and "renal and urinary disorders" being the most reported to date, a detailed analysis was performed Results: A total of 76 patients were included in the study from March 13 to December 31, 2020. The most common AEs were metabolism and nutrition disorders, hepatobiliary disorders, gastrointestinal dis- orders and renal and urinary disorders. Patients with hepatobiliary disorders had mainly include transami- nases increases and 60% had pre-existing hepatobiliary disease that worsened during treatment. The median time to onset or worsening of hepatobiliary disease was one day [1-2]. It led to discontinuation of treatment in one case. Among patients with renal and urinary disor- ders, 50% had increased blood creatinine levels prior therapy initiation. The median time to onset or worsening of renal and urinary disorders was one day [0-16]. It led to discontinuation of treatment in two cases. Conclusion: A potential signal of pharmacovigilance has been identified for liver and renal disorders in Vigilyze® and we have reported the expected remdesivir Aes. However, it is difficult to suspect remdesivir only without considering the pathology itself, but remdesevir appears to have favorable safety profile in patients who require minimal supplemental oxygen.

18.
Drug Safety ; 45(10):1189-1190, 2022.
Article in English | ProQuest Central | ID: covidwho-2045080

ABSTRACT

Introduction: Sotrovimab is a monoclonal therapy authorized for emergency use (EUA) on May 26, 2021, by the US (FDA) for treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and children > 12 years old). The drug showed positive viral testing in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and, reduced risk for progressing to severe COVID-19, including hospitalization or death1. Objective: This paper reviewed published data on safety of Sotrovimab 500mg in COVID-19 patients. Methods: The study based on reviewing published literature. Pubmed and FDA web was searched for data on Safety of Sotrovimab use in COVID-19 patients (May2021-May2022). Results: Gupta A et al2 reported among (n = 291 Sotrovimab group, n = 292 placebo group) mild diarrhea occurred in 5 cases (1%) in Sotrovimab group, compared to 1 case of moderate diarrhea, while diarrhea occurred in 3 patients in placebo group. One patient who received Sotrovimab had moderate dyspnea, an infusion-related reaction that was related to Sotrovimab. Hospitalization adverse events occurred in 2% of Sotrovimab group and in 6% in placebo group. No death or serious adverse events e.g., hematological disorders or liver damage were related to Sotrovimab. Further study by Gupta A et al3 for Sotrovimab (n = 528) or placebo (n = 529) reported that adverse events were infrequent and are similar between two groups (22% for Sotrovimab vs 23% for placebo);the most common events were diarrhea with Sotrovimab (n = 8;2%) and COVID-19 pneumonia with placebo (n = 22;4%). Kreuzberger N et al4 reported treatment with Sotrovimab may reduce the number of participants with oxygen requirement weaned in 3 days and risk of all-cause hospitalization or death without exhibiting significant adverse reaction. Fernandes G et al5 observed that following administration of Sotrovimab to kidney transplant recipients infected with Omicron variant, two patients required hospitalization for oxygen therapy. None were admitted to the intensive care unit or died. Conclusion: This review found limited number of safety studies of Sotrovimab in COVID-19, which reflects low numbers of publications. This is probably because of the Emergency utilization of drug and limitation of use in many countries. Lately, FDA US announced Sotrovimab is no longer authorized to treat COVID-19 in US due to increases in the proportion of COVID-19 cases caused by the Omicron variants6. Further data is needed to evaluate Sotrovimab safety in COVID-19 patients and examine risk-benefit, adverse events, and risk correlation to disease severity in patients with various risk factors.

19.
Vestnik Rossiyskoy voyenno meditsinskoy akademii ; 3:49-54, 2021.
Article in Russian | GIM | ID: covidwho-2040519

ABSTRACT

This study presents the results of the examination of potential donors of blood and its components for immunoglobulins M and G to patients with coronavirus disease 2019 (COVID-19) living in St. Petersburg. A total of 6782 people aged 18-24 years were evaluated, which accounted for 2.07% of the region's population (326 760 people) of this age group. The study was carried out in the spring and autumn of 2020. A negative result (absence of antibodies) was obtained in 93.5% of the participants. The rates of immunoglobulins M and M + G were 0.58% and 4.18%, respectively, in the spring and autumn. Moreover, the number of participants who had immunoglobulins M and G + M in the autumn period was four times higher than the indicators of the spring period, which indicated greater infection activities in the population during this period. This is most likely due to the active movement of the population in the summer. When comparing the rates of COVID-19 infection and the frequency of occurrence in donors of the same age, markers of human immunodeficiency virus 1 and 2 and hepatitis B and C in 2020 (0.024, 0.012 and 0.13%, respectively) indicate the urgency of the problem of donor selection during blood services, especially during a difficult epidemiological situation because of COVID-19. Along with organizational measures for the selection of donors (e.g., attracting individuals from organized groups in which there are no signs of an unfavorable epidemiological situation to donation), mandatory testing of potential donors for immunoglobulins M and G should be considered.

20.
Sri Lankan Journal of Infectious Diseases ; 12(2), 2022.
Article in English | CAB Abstracts | ID: covidwho-2040071

ABSTRACT

The COVID-19 pandemic has caused resource depletion and a shift in priorities in the public health system, impacting the control of other communicable diseases of public interest. Hepatitis A virus is a notifiable disease transmitted through faeco-oral transmission. We conducted a retrospective analysis of patients with a clinical diagnosis of hepatitis whose specimens were submitted to the Virology Laboratory of the National Hospital, Kandy, from January 2019 to December 2021. During pre-pandemic time 28 (4.4%) were positive for hepatitis A, while it was 86 (10.2%) during the pandemic. There was a statistically significant difference in incidence between the two cohorts (p < 0.0001). The majority of patients in 2021 (25 patients;64.1%) resided in Badulla. Our data shows an increased incidence of hepatitis A cases during the pandemic, and residents in Badulla were predominantly affected in 2021. Strategies should therefore be undertaken to prevent further cases in the central part of the country.

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