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Diabetes mellitus and advanced liver fibrosis are risk factors for severe anaemia during telaprevir-based triple therapy.

ABSTRACT: Adding telaprevir to pegylated-interferon and ribavirin increased both response rates and side effects of hepatitis C virus (HCV) treatment. We identified variables associated with severe anaemia during telaprevir-based triple therapy.An observational study was performed on 142 HCV-infected patients between June 2011 and March 2012. All subjects completed 12 weeks of telaprevir-based triple therapy or discontinued early because of anaemia. Severe anaemia was defined by a haemoglobin?8.9 g/dl; advanced fibrosis was determined by Fib-4?3.25.The 47 (33%) patients who developed severe anaemia were similar to those who did not in sex, race, and prior response to dual therapy, but they were more likely to have diabetes (23.4% vs. 6.3%, P<0.01), advanced fibrosis (46.8% vs. 29.5%, P=0.04) and a history of anaemia during previous dual therapy (29.7% vs. 11.4%, P=0.02). Patients developing severe anaemia were older (59 vs. 56 years, P=0.02), had lower baseline platelet counts (134 vs. 163×10(9) /L, P=0.04), haemoglobin (14.0 vs. 15.0 g/dl, P<0.01), estimated glomerular filtration rate (79 vs. 90 ml/min/1.73 m2, P=0.03) and a higher median ribavirin/weight ratio (14.9 vs. 13.2 mg/kg, P<0.01). In multivariable logistic regression, presence of diabetes (OR=5.61, 95% CI: 1.59-19.72), Fib-4?3.25 (OR=3.09, 95% CI: 1.28-7.46), higher ribavirin/weight ratio (OR=1.31 per mg/kg, 95% CI: 1.13-1.52) and lower baseline haemoglobin (OR=0.57 per g/dl, 95% CI, 0.41-0.80) were independently associated with developing severe anaemia.Severe anaemia occurred in one-third of patients receiving telaprevir-based triple therapy. Risk was greater in patients with diabetes, advanced liver fibrosis, higher ribavirin/weight ratio and lower baseline haemoglobin.

SUBMITTER: Crismale JF

PROVIDER: S-EPMC3972374 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

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Diabetes mellitus and advanced liver fibrosis are risk factors for severe anaemia during telaprevir-based triple therapy.

Crismale James F JF Martel-Laferrière Valérie V Bichoupan Kian K Schonfeld Emily E Pappas Alexis A Wyatt Christina C Odin Joseph A JA Liu Lawrence U LU Schiano Thomas D TD Perumalswami Ponni V PV Bansal Meena M Dieterich Douglas T DT Branch Andrea D AD

Liver international : official journal of the International Association for the Study of the Liver 20131025 7

<h4>Background & aims</h4>Adding telaprevir to pegylated-interferon and ribavirin increased both response rates and side effects of hepatitis C virus (HCV) treatment. We identified variables associated with severe anaemia during telaprevir-based triple therapy.<h4>Methods</h4>An observational study was performed on 142 HCV-infected patients between June 2011 and March 2012. All subjects completed 12 weeks of telaprevir-based triple therapy or discontinued early because of anaemia. Severe anaemia ...[more]

PMID: 24118693

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Project description:ImportanceAdvanced liver fibrosis is a precursor to cirrhosis, a leading cause of mortality. People with severe psoriasis are at risk for liver disease, but our understanding of advanced fibrosis in individuals with psoriasis is limited.ObjectivesTo describe the prevalence of and evaluate the clinical factors associated with advanced liver fibrosis in people with severe psoriasis.Design, setting, and participantsThe Co-morbidities in Severe Psoriasis study, a prospective observational cohort study in a large center serving London and Southeast England, was conducted from October 18, 2012, to April 2, 2015; 400 adults with severe psoriasis (Psoriasis Area Severity Index score, ≥10) were recruited from outpatient clinics. Statistical analysis was conducted from October 2, 2016, to March 3, 2017.Main outcomes and measuresThe primary outcome was a diagnosis of advanced liver fibrosis determined by transient elastography, a noninvasive criterion standard test. Clinical factors evaluated included psoriasis-specific and metabolic indices, alcohol use, and methotrexate exposure.ResultsOf 400 patients recruited (108 women and 289 men; mean [SD] age, 49.5 [13] years), 333 had a successful transient elastography scan and were included in final analysis. Forty-seven patients (14.1%; 95% CI, 10.4%-17.9%) had advanced liver fibrosis as diagnosed by transient elastography. The clinical factors that produced the best-fit model for advanced fibrosis were central obesity (waist circumference), insulin resistance, aspartate aminotransferase level, platelet count, psoriasis disease severity, and reduced alcohol use (R2 = 0.54).Conclusions and relevanceFindings from this study suggest that advanced fibrosis is common in severe psoriasis. Abdominal obesity (by waist circumference) and insulin resistance were associated with the presence of advanced fibrosis. Longitudinal work to characterize the hepatic sequelae of central obesity, insulin resistance, and inflammation as well as the influence of systemic drugs (methotrexate and biologics) will inform future personalized therapeutic decision-making.Trial registrationClinicalTrials.gov identifier: NCT02174367.

Project description:Type 2 diabetes mellitus (T2DM) is closely related to hepatic steatosis and fibrosis. The aim of this study was to analyze the occurrence of hepatic steatosis and fibrosis in patients with T2DM and to explore the risk factors.A total of 629 patients with T2DM were enrolled. Liver stiffness value (LSV) and controlled attenuation parameters (CAP) were measured using Fibroscan. Liver fibrosis was diagnosed when LSV was greater than 7.4?kPa, and advanced liver fibrosis was diagnosed when LSV was greater than 10.6?kPa. Hepatic steatosis diagnosis was made when CAP value was greater than 238?dB/m. Demographic information, physical examination data, and laboratory tests results were collected. The 629 patients were classified into 2 groups by the liver fibrosis and liver steatosis, and then the difference was analyzed.Among patients enrolled, 231 patients were diagnosed as liver fibrosis. The age of the patients in the fibrosis group was significantly greater than that in the non-fibrosis group, and similar trends were observed in the waist-hip ratio (WHR), systolic blood pressure, and diastolic blood pressure. The proportion of smoking and alcoholic consumption was significantly lower in patients with non-fibrosis group. A total of 426 patients were diagnosed with liver steatosis. Body mass index (BMI), WHR, systolic blood pressure, and diastolic blood pressure in patients with steatosis were significantly higher than those in non-steatosis group. We observed that the LSV (P?=?.042) and CAP value (P?<?.001) are positively correlated with metabolic syndrome components in T2DM patients. Older age (OR?=?1.099, P?=?.001), high BMI (OR?=?1.088, P?=?.003), low platelet level (OR?=?0.996, P?=?.014), and smoking (OR?=?1.653, P?=?.013) were independent risk factors of liver fibrosis among T2DM patients. High BMI (OR?=?1.369, P?<?.001), high diastolic blood pressure (OR?=?1.048, P?<?.001), and high gamma glutamyl transpeptidase (OR?=?1.018, P?=?.009) were independent risk factors for liver steatosis among T2DM patients.This study suggested risk factors screening of liver fibrosis and steatosis. Timely intervention should be taken into consideration among high risk patients to prevent progress liver diseases.

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Diabetes mellitus and advanced liver fibrosis are risk factors for severe anaemia during telaprevir-based triple therapy.

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Diabetes mellitus and advanced liver fibrosis are risk factors for severe anaemia during telaprevir-based triple therapy.

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