Elevated Liver Enzymes In Patients Research Articles

Incidence of Elevated Liver Enzyme Levels in Patients Receiving Remdesivir and Its Effective Factors.

Emergency use of remdesivir was approved for COVID-19 in some countries. Based on the promising results of remdesivir, the most common side effects were nausea, worsening respiratory failure, increased alanine aminotransferase levels, and constipation. The aim of this study was to determine the incidence of elevated liver enzymes in patients with COVID-19 receiving remdesivir. In this retrospective study, information was collected from patients' files. The study population included patients with moderate to severe COVID-19 who were admitted to Rouhani Babol Hospital. For daily patient selection, the list of patients was extracted from the system, and based on the census, the patient file was selected. Data were analyzed using Stata 16. 620 patients suffering from moderate to severe COVID-19 were included in this study, 43% of whom were men. Of these patients, 120 were selected as the control group who did not receive remdesivir. The increase in liver enzymes in patients receiving remdesivir compared with the control, for alanine transaminase (ALT) and aspartate transaminase (AST), respectively, was 6.20 and 3.64 times, but it was not statistically significant for alkaline phosphatase (ALP). Also, the increase in bilirubin levels in patients receiving remdesivir was not statistically significant. The recipients of remdesivir had high liver enzymes, which is one of the possible side effects of this drug. The intensity of the enzymes was mild and moderate, and they were not dangerous to the health of any of the consumers. Deaths in patients with COVID-19 were not due to drug-induced liver complications but to other factors such as disease-related complications.

Effect of statin use on liver enzymes and lipid profile in patients with non-alcoholic fatty liver disease (NAFLD)

Non-alcoholic fatty liver disease (NAFLD) is an independent risk factor for cardiovascular disease (CVD). Statins are recommended for treatment of dyslipidemia to reduce the overall cardiovascular risk in patients with NAFLD. However, statin treatment was underutilized and the effect of statins on liver enzymes remained unclear in this patient population. This study aimed to provide real-world evidence of the safety and effect of statin use in patients with NAFLD. We conducted a cross-sectional survey study of adults with NAFLD using pooled data from the US NHANES database 2009-2018. NAFLD was defined by Fatty Liver Index (FLI) ≥ 60 and United States Fatty Liver Index (USFLI) ≥ 30. Multivariate regression analyses adjusted for baseline clinical and demographic characteristics were performed to compare the liver enzymes and lipid profile between statin and non-statin users. The study included 2,533 adults with NAFLD, representing 22.6 million individuals in the US, with 27% receiving statin treatment between 2009 and 2018. The mean differences of liver enzymes for AST, ALT, ALP, and GGT between statin and non-statin users were -0.86 (p=0.539), -3.49 (p=0.042), -0.25 (p=0.913), and 0.57 (p=0.901), respectively. In individuals with NAFLD and dyslipidemia, total cholesterol and LDL levels were significantly lower in statin users compared to non-statin users (mean difference, -28.9; p<0.001 and -27.7; p<0.001). The use of statins was not associated with elevated liver enzymes in patients with NAFLD. Significantly lower levels of ALT, total cholesterol, and LDL were observed in statin users compared to non-statin users.

Factors associated with elevated liver enzymes in patients with uncontrolled hyperthyroidism

Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

Nonalcoholic Fatty Liver Disease Is a Risk Factor for Thiopurine Hepatotoxicity in Crohn's Disease.

Patients with Crohn's disease (CD) are predisposed to nonalcoholic fatty liver disease (NAFLD). CD management often includes thiopurines which can promote hepatotoxicity. We aimed to identify the role of NAFLD on the risk of developing liver injury from thiopurines in CD. In this prospective cohort analysis, CD patients at a single center were recruited 6/2017-5/2018. Patients with alternative liver diseases were excluded. The primary outcome was time to elevation of liver enzymes. Patients underwent MRI with assessment of proton density fat fraction (PDFF) on enrollment, where NAFLD was defined as PDFF >5.5%. Statistical analysis was performed using a Cox-proportional hazards model. Of the 311 CD patients studied, 116 (37%) were treated with thiopurines, 54 (47%) of which were found to have NAFLD. At follow-up, there were 44 total cases of elevated liver enzymes in those treated with thiopurines. Multivariable analysis demonstrated that NAFLD was a predictor of elevated liver enzymes in patients with CD treated with thiopurines (HR 3.0, 95% CI 1.2-7.3, P = .018) independent of age, body mass index, hypertension, and type 2 diabetes. Steatosis severity by PDFF positively correlated with peak alanine aminotransferase (ALT) at follow-up. Kaplan-Meier analysis demonstrated poorer complication-free survival (log-rank 13.1, P < .001). NAFLD at baseline is a risk factor for thiopurine-induced hepatotoxicity in patients with CD. The degree of liver fat positively correlated with the degree of ALT elevation. These data suggest that evaluation for hepatic steatosis be considered in patients with liver enzyme elevations with thiopurine therapy.

Outcome of Elevated Liver Enzymes in Patients with COVID-19 Infection

Outcome of Elevated Liver Enzymes in Patients with COVID-19 Infection

Enhancing current human immunodeficiency virus/hepatitis B and human immunodeficiency virus/hepatitis C virus co-infection management.

Enhancing current human immunodeficiency virus/hepatitis B and human immunodeficiency virus/hepatitis C virus co-infection management.

The Elevation of LIVER Enzymes in Patients with Atrial Fibrillation and COVID-19 Is a Marker of Bad Evolution and Mortality

Introduction: The COVID-19 pandemic reflects liver damage. A study carried out in China (Guan WJ et al. N Engl J Med. 2020) reported that in more than 21% of cases there was an elevation of liver enzymes (ELE), with only 2.1% of them having previous liver disease. ELE is frequent in anticoagulated patients and is associated with an increased cardiovascular risk and bleeding complications2,3. It is necessary to evaluate the impact of ELE in patients with atrial fibrillation (AF) and COVID-19 Methods: Multicenter, retrospective and observational study that consecutively included patients admitted with COVID-19 during the months of March and April 2020. The patients were followed were followed up until 30 days after discharge or death. termino en inglés ¿??Anticoagulation was chosen at the clinical discretion. The main variables investigated were the value of liver enzymes (AST, ALT, GGT) at admission, during the first week (peak value) and at hospital discharge. Patients who achieved a 3-fold higher level of ELE(> 120UI) were described as high-risk transaminasemia (HRT). The number of bleedings, thromboembolic events, as well as all-cause mortality were evaluated. Statistical analysis was performed with SPSS 21.0 (SPSS Inc., Chicago, IL). Results: A total of 235 patients were included. The mean age was 79 years [standard deviation (SD) 7.9. years]. The demographic characteristics of the patients with and without HRT are summarized in Table 1. The median follow-up was 59 days (SD 29 days). In AF patients, ELE values rose significantly on admission with respect to discharge p <0.05. No significant difference in the value of ELE was found between those who received LMWH versus ACODS. In patients with AF, there were 30 admissions to intensive care, these had higher ELE values at admission and at discharge, awith ALT at admission and ALT, AST and GGT at discharge being significant, p <0.05. They also presented 24 (10%) bleeding events, which had a significantly higher AST level in the first week (42-60UI). There were 45 (19.1%) patients who died during de follow-up, ELE values were significantly higher on admission. Finally, if we analyze the events in the 48 HRTpatients (21%) compared to the non-TAR 187 patients (79%), they had significantly more hemorrhagic events, and death from all causes, p <0.05, events was resume in Table 2. If we perform a logistic regresión for TAR as a predictor variable of bleddings events, TAR was a risk marker ,independly OR 3,6(1,39-9,33), table 3 Conclusion: In our cohort, AF patients who suffered events had a higher ELE than those who did not suffer significantly. Furthermore, the patients classified as HRT presented an increase in mortality, bleedings events compared to non-HRT (Table 2 and 3). No significant differences were observed in the elevation of the ELE according to the antithrombotic treatment, the patients treated with DOACs did not experience a significant increase in the ELE during the follow-up.DisclosuresOlivera:Daiichi Sankyo:Consultancy, Speakers Bureau;BAYER:Consultancy;Boehringer Ingelheim:Consultancy, Speakers Bureau;Pfizer:Consultancy, Speakers Bureau.Campoy Castaño:Boehringer Ingelheim:Consultancy;Daiichi Sankyo:Speakers Bureau.Sierra:Astellas:Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees;Novartis:Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau;Abbvie:Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau;Jazz Pharmaceuticals:Research Funding;Pfizer:Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau;Daiichi Sankyo:Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau;Roche:Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees;Gilead-Kite:Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees.

Elevated Liver Enzymes in Patients with COVID-19: Look, but Not Too Hard

Elevated Liver Enzymes in Patients with COVID-19: Look, but Not Too Hard

Liver enzyme elevation in patients with ankylosing spondylitis treated with tumor necrosis factor inhibitors: a single-center historical cohort study.

Background/AimsTumor necrosis factor inhibitors (TNFi) have been known to induce liver enzyme elevation, sometimes associated with viral reactivation or toxic hepatitis. We evaluated the incidence and risk factors of TNFi-associated liver enzyme elevation in Korean ankylosing spondylitis (AS) patients who previously had normal liver enzymes.MethodsRetrospectively, we collected data from the records of 363 AS patients treated with TNFi at a tertiary hospital from 2003 to 2017. Liver enzyme elevation was defined as abnormal elevation of aspartate aminotransferase and/or alanine aminotransferase levels on two or more consecutive visits. Patients with previously diagnosed liver disease were excluded.ResultsThe incidence of liver enzyme elevation was 23.7% (occurring in 86 of 363 patients). The median duration of TNFi exposure before liver enzyme elevation was 3.72 months (interquartile range, 1.77 to 12.51). There was no difference in the occurrence of liver enzyme elevation with concomitant disease-modifying anti-rheumatic drugs and TNFi compared to TNFi alone (23.9% vs. 23.6%). In multivariate analysis, the hazard ratios for liver enzyme elevation were 4.62 (95% confidence interval [CI], 1.43 to 15.01) for male sex, 4.06 (95% CI, 2.11 to 7.84) for underlying non-alcoholic fatty liver disease, and 2.53 (95% CI, 1.38 to 4.64) for hyperlipidemia. After switching to another TNFi, the liver enzyme elevation was not normalized in nine of 13 patients.ConclusionsLiver enzyme elevation was observed in a quarter of patients with AS receiving a TNFi. Male sex, non-alcoholic fatty liver disease, and hyperlipidemia were independent risk factors for liver enzyme elevation. Switching to another TNFi had a limited effect on restoring normal liver enzyme levels.

Elevated Liver Enzymes in Patients with Type 2 Diabetes Mellitus and Non-alcoholic Fatty Liver Disease.

BackgroundNon-alcoholic fatty liver disease (NAFLD) is emerging as the most common chronic liver condition. Approximately 70% of type 2 diabetes mellitus (T2DM) patients have a fatty liver; the progression to non-alcoholic steatohepatitis (NASH) dramatically increases the risks of cirrhosis and hepatocellular carcinoma. The aim of our study was to assess the profile of liver enzymes in subjects with T2DM and NAFLD.MethodThis was a cross-sectional clinic-based study in patients with T2DM. An ultrasonography of the abdomen was done in all patients in order to examine the presence of a fatty liver. Body mass index (BMI), lipid profile, and liver enzymes were also analyzed in all patients. Institutional Review Board (IRB) approval was provided by the National Academy of Medical Sciences, Bir Hospital, Nepal. Unpaired t-test, Chi-square/Fisher's exact test (for categorical variables), and the Pearson/Spearman correlation test were used to find a significant difference, association, and correlation between two or more groups, respectively. The Statistical Package for Social Sciences (SPSS)® Statistics, version 16 (IBM SPSS Statistics, Armonk, NY) was used to analyse the data.ResultsThe study was carried out in 210 patients, and out of the 210 patients, 119 (56.6%) were male and 91 (43.3%) were female. The patients were divided into two groups, i.e., the normal alanine aminotransferase (ALT) group and the elevated ALT group. The mean age of the patients was 56.28 ± 12.3 years in the normal alanine aminotransferase (ALT) group and 58.6 ± 24.7 in the elevated ALT group. The number of T2DM patients with a fatty liver was 117 (55.7%) and those with a non-fatty liver was 93 (44.2%) based on an ultrasonography scan. Subjects with NAFLD had a significantly higher ALT (p < 0.001) but no significant rise in serum aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), and alkaline phosphatase (ALP) levels. The area under the receiver operating characteristic (AUROC) curve for the prediction of fatty liver based solely on the ALT was 0.84 with the confidence interval (CI) between 0.76 and 0.92 (p < 0.05).ConclusionsNon-alcoholic fatty liver disease is highly prevalent in patients with T2DM. Timely diagnosis and management of the abnormal liver parameters may help to minimize liver-related morbidity and mortality in the diabetic population.

Discovery of Vilaprisan (BAY 1002670): A Highly Potent and Selective Progesterone Receptor Modulator Optimized for Gynecologic Therapies.

Progesterone plays an important role in the female reproductive system. However, there is also evidence that gynecologic disorders/diseases such as uterine fibroids and endometriosis are progesterone‐dependent. Steroidal and non‐steroidal selective progesterone receptor modulators (SPRMs) have shown potential for the treatment of such diseases. Steroidal SPRMs, including mifepristone and ulipristal acetate, have proven effective in clinical trials. However, several steroidal SPRMs containing a dimethylamino substituent have been associated with elevated liver enzymes in patients. An earlier drug discovery program identified lonaprisan as a highly selective SPRM that did not show drug‐related change in liver enzyme activity. Building on data obtained from that work, here we describe the research program that culminated in the discovery of a novel steroidal SPRM, vilaprisan, which combines an extremely high potency with very favorable drug metabolism and pharmacokinetic properties. Vilaprisan has entered clinical development and is currently undergoing phase 3 clinical trials.

Assessing risk of liver enzyme elevation in patients with immune-mediated diseases and different hepatitis B virus serostatus receiving anti-TNF agents: a nested case-control study

BackgroundLiver enzyme elevation is an important and common adverse effect among patients with immune-mediated diseases who receive tumour necrosis factor inhibitors (anti-TNF), and has various causes. Hence, we evaluated the relative risks of developing liver enzyme elevation in anti-TNF users with differing hepatitis B virus (HBV) infection status.MethodsAt a hospital in central Taiwan, 407 patients with rheumatoid arthritis, ankylosing spondylitis, or psoriasis/psoriatic arthritis received anti-TNF therapy between 1 January 2004 and 30 June 2012. We performed a nested case-control study (n = 368) of cases with serum alanine aminotransferase (ALT) > 40 international units/L ≤ 12 months after starting anti-TNF therapy, and corresponding controls without liver enzyme elevation. Conditional logistic regression was used to evaluate associations between liver enzyme elevation and HBV serostatus, as well as other risk factors.ResultsThirty cases were compared to 338 controls. After adjustment for potential confounders, HBV surface antigen-positive (HBsAg+) serostatus was associated with substantially higher likelihood of developing elevated ALT (adjusted odds ratio 7.91, 95% confidence interval (CI) 2.16–31.31) relative to those with an uninfected HBV status; no such association was observed among HBsAg-negative/HBV core antibody-positive (HBsAg–/HBcAb+) patients (adjusted odds ratio 1.00, 95% CI 0.33–3.25). Increased risk of ALT elevation was associated with methotrexate used alone, without folic acid (adjusted odds ratio 11.60, 95% CI 2.52–56.46), and history of ALT elevation (adjusted odds ratio 13.71, 95% CI 4.32–45.75).ConclusionsHBsAg+ patients with immune-mediated diseases who received anti-TNF therapy had an approximately eight-fold higher likelihood of liver enzyme elevation than those without HBV infection, whereas patients with HBsAg–/HBcAb+ serostatus had a risk similar to that of uninfected patients.

Associations of Elevated Liver Enzymes among Hospitalized Adolescents with Anorexia Nervosa

To analyze the prevalence, predictors, and evolution of increased liver enzymes in a large sample of adolescents hospitalized with anorexia nervosa (AN). Electronic medical records of all subjects 10-22years of age with AN, first admitted to a tertiary children's hospital from January 2007 to December 2012, were reviewed retrospectively. Demographic factors, anthropometric factors, initial prescribed calories, and alanine aminotransferase levels were recorded. Multivariate analysis was performed to assess the effect of sex, degree of malnutrition, and initial calories prescribed on having alanine aminotransferase ≥40 IU/L. A total of 356 subjects met eligibility criteria (age 16.1±2.4; 89.0% female; admission body mass index [BMI] 15.9±1.9; admission percentage median BMI 78.2±8.5), with elevated liver enzymes present in 37.0% on admission and in 41.1% at any point during the hospitalization. Lower percentage median BMI (aOR 0.96; 95% CI 0.93-0.98) and male sex (aOR 0.45; 95% CI 0.22-0.94) were significantly associated with odds of elevated liver enzymes on admission. Higher initial prescribed calories were associated with odds of elevated liver enzymes after admission (aOR 1.81; 95% CI 1.04-3.18). In this study of AN and elevated liver enzymes, the degree of malnutrition and male sex predicted elevated liver enzymes on admission but initial prescribed calories also may be associated with elevated liver enzymes after admission in a small proportion of patients. Future research should better characterize the evolution of elevated liver enzymes in patients hospitalized with AN undergoing refeeding.

Benefits of exenatide on obesity and non-alcoholic fatty liver disease with elevated liver enzymes in patients with type 2 diabetes.

The purpose of this study was to evaluate the advantages of exenatide treatment on obesity and non-alcoholic fatty liver disease (NAFLD) with elevated liver enzymes in patients with type 2 diabetes (T2D). A total of 60 newly diagnosed patients with obesity, NAFLD with elevated liver enzymes and T2D were included in the study. The patients were randomly divided into two groups. The exenatide treatment group (n = 30) were treated with exenatide and insulin glargine, and the intensive insulin therapy group (n = 30) were treated with insulin aspart and insulin glargine for 12 weeks. Selected clinical characteristics were determined, and ultrasonography was performed at both baseline and 12 weeks following treatment. At baseline, the clinical characteristics were matched between the two groups. After 12 weeks, fasting blood glucose (FBG), postprandial blood glucose (PBG), glycosylated haemoglobin (HbA1c), total cholesterol (TC), triglyceride (TG) and total bilirubin levels were significantly decreased in the two groups (p < 0.001). Body weight and waist circumference were significantly decreased in the exenatide group but increased in the intensive insulin group (p < 0.001). The levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and γ-glutamyl transpeptidase (γGGT) in the exenatide group were significantly lower than in the intensive insulin group (p < 0.001). The mean body weight change correlated with the levels of ALT, AST and γGGT change (ALT, r = 0.761; AST, r = 0.733; γGGT, r = 0.752; p < 0.001). Moreover, the reversal rate of fatty liver was significantly higher in the exenatide group (93.3%) than the intensive insulin group (66.7%) (p < 0.01). Exenatide has a better hepatic-protective effect than intensive insulin therapy and perhaps represents a unique option for adjunctive therapy for patients with obesity, non-alcoholic fatty liver disease with elevated liver enzymes and T2D.

Association of iron overload with non-alcoholic fatty liver disease in patients with type 2 diabetes

Objective To analyze the association of fat content,enzymes,and fibrosis in liver with iron overload in patients with type 2 diabetes,and to explore the relationship between iron overload and severity of nonalcoholic fatty liver disease (NAFLD) in these patients.Methods Five hundred and thirty hospitalized patients with type 2 diabetes and 18 patients with abnormal glucose metabolism undergoing liver biopsy were recruited.History data,results of laboratory tests,liver ultrasound,hepatic 1 H-MRS were collected and serum ferritin level was determined.Results The serum ferritin level was significantly higher in patients with NAFLD than that without NAFLD [(328.7±252.2 vs 239.9 ± 171.8) μg/L,P＜0.01].Serum ferritin was an independent risk factor for NAFLD (P＜0.05).Multiple linear regression analysis showed that serum ferritin was positively correlated with liver fat content after adjustment for sex,age,and duration of diabetes.The serum ferritin level in NAFLD with elevated liver enzymes was significantly higher than that in simple steatosis [(429.9 ± 287.4 vs 293.4 ± 233.3) μg/L,P＜0.01].Serum ferritin was an independent risk factor for elevated liver enzymes in patients with NAFLD (P ＜0.05).Serum ferritin level in patients with advanced fibrosis was significantly lower than that in patients without advanced fibrosis [(246.8 ± 191.2 vs 382.5 ± 253.7) μg/L,P＜0.01].In 18 patients with NAFLD proven by biopsy,serum ferritin level was slightly higher in NASH group than that in simple steatosis group,but there was no statistically significant difference.Serum ferritin levels were comparable between patients with and without advanced fibrosis.Conclusion The iron overload in type 2 diabetic patients seems to be an independent risk factor for the development of NAFLD and elevated liver enzymes.Iron load in patients with advanced fibrosis is significantly decreased. Key words: Diabetes mellitus, type 2 ; Non-alcoholic fatty liver disease ; Serum ferritin ; Histopathology

Elevated liver enzymes following polytraumatic injury.

This retrospective cohort study examined the prevalence and potential risk factors for elevated liver enzymes in patients following traumatic brain injury (TBI). The participants were servicemembers with TBI admitted to the Polytrauma Rehabilitation Center (PRC) at the Hunter Holmes McGuire Department of Veterans Affairs Medical Center in Richmond, Virginia, from January 2008 through December 2011. The PRC had 207 patients during this time period, 121 of whom had a liver panel within 30 d of injury. Patients were retrospectively analyzed and placed into one of two categories based on alanine aminotransferase (ALT) values. Of the 121 subjects, 59 (49%) had an ALT of 44 IU/L or greater on their initial set of laboratories. These subjects were compared with those with an ALT of 43 IU/L or less using chi square analysis. There were no significant differences between the two groups with regards to sex, military status, race, theater, TBI mechanism, severity of TBI, or concomitant injuries. Regardless of demographics, mechanism of injury, or extent of trauma, elevated liver enzymes are common in patients admitted to the rehabilitation unit following TBI. For the majority of these patients, enzymes returned to normal with conservative management. In most cases, no specific etiology was ever defined. Further analysis will be performed to determine the most efficient way to monitor these patients so that unnecessary test are avoided and medical expenses are minimized.

Elevated Liver Enzymes in Patients with Cholecystitis

Aims: To investigate changes in liver function tests in calcular cholecystitis (acute and chronic) and to relate that changes to cholecystitis. Methods: A retrospective study including 389 patients with clinical and sonographic evidence of cholecystitis with exclusion of other causes of elevated liver function tests, which are done preoperatively and four weeks postoperatively. Results: Increased liver function tests observed in both acute and chronic cholecystitis. The only significant differences between both groups were a higher bilirubin level (P= 0.001) and WBC (P= 0.018). Pre and post-cholecystectomy levels of AST, ALK-P and GGT were significantly changed (P= 0.001). Conclusion: Our study showed that the abnormal biochemical liver function tests resolved rapidly and spontaneously after cholecystectomy indicating transient hepatocellular injury with cholecystitis.

Elevated liver enzymes in patients with ankylosing spondylitis treated with etanercept

TNF-alpha blocking agents are very effective in patients with ankylosing spondylitis (AS), but several cases of liver problems have been published. We systematically studied the frequency of this potential side effect in our AS patients treated with etanercept. Consecutive AS patients treated with etanercept for at least 3 months were included. Liver disease was defined as elevated liver enzymes more than 1.5 times the upper normal limit (UNL) and was categorised as probably, possibly, probably not or not related to etanercept treatment. Patients with and without raised liver enzymes were compared for prognostic factors. A total of 105 patients were included. Fifteen patients had elevated liver enzymes more than once. In nine cases, the liver disease was probably (five) or possibly (four) related to etanercept treatment. The liver enzyme elevations were serious (>3× UNL) in six cases and resulted in permanent cessation of etanercept in two cases. The nine patients with liver disease were compared with patients without elevated liver enzymes. No differences were found in age or use of alcohol; however, in patients with liver disease, a higher body mass index and a trend for a higher atherogenic index were observed. Hepatic steatosis was observed in five of six patients with elevated liver enzymes. Elevated serum aminotransferases, probably or possibly related to etanercept treatment, were observed in 9 % of the AS patients. An increased risk for the elevation of liver enzymes was found in patients with a higher body mass index. We recommend regular testing of liver enzymes in patients treated with etanercept.

Body iron, serum ferritin, and nonalcoholic fatty liver disease

Body iron, serum ferritin, and nonalcoholic fatty liver disease

Hepatic safety profile of raltegravir in HIV-infected patients with chronic hepatitis C

Patients with chronic hepatitis C virus (HCV) infection experience antiretroviral-associated liver toxicity more frequently than HIV mono-infected persons. Herein, we report the hepatic safety profile of raltegravir in a relatively large group of HIV/HCV co-infected patients, a population that was poorly represented in the registrational studies. Prospective, observational study of all antiretroviral-experienced HIV-infected patients who initiated raltegravir from January 2006 to January 2009 at a reference HIV clinic. Clinical data, laboratory parameters and liver stiffness measured at baseline, week 4 and every 3 months thereafter were collected. Chronic hepatitis C was defined as positive serum HCV-RNA. Grade 1-4 hepatotoxicity was defined following the AIDS Clinical Trials Group definition for liver enzyme elevations (LEEs). A control group of patients who initiated protease inhibitors (PIs) or non-nucleoside reverse transcriptase inhibitors (NNRTIs) was examined similarly. Data from 218 HIV-infected patients on raltegravir were analysed, 126 HIV mono-infected and 92 HIV/HCV co-infected patients. Any degree of LEEs occurred in 10 (7.9%) HIV mono-infected and 23 (25%) co-infected patients (relative risk 3.1; 95% confidence interval 2.9-3.4; P = 0.002). Severe hepatotoxicity (grade 3-4), however, was only seen in 3 (1.4%) patients, all co-infected with HCV. It occurred at months 1, 15 and 15, respectively. In all three subjects other reasons than raltegravir exposure most likely explained LEEs. Multivariate analysis revealed HCV co-infection as the only independent variable associated with any degree of hepatotoxicity on raltegravir (P = 0.03). Finally, the rate of LEEs in patients on raltegravir was lower than in those who were treated with PIs or NNRTIs. LEEs are less frequent in patients treated with raltegravir than with other antiretroviral drug classes. However, HIV/HCV co-infected patients treated with raltegravir experienced LEEs more frequently than HIV mono-infected persons. In this series, LEEs in patients treated with raltegravir were uniformly mild and no cases of grade 3-4 hepatotoxicity could be directly attributed to the drug. These results reinforce the overall hepatic safety profile of raltegravir.