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Serum Fibrosis Markers for the Diagnosis of Liver Disease Among People With Chronic Hepatitis C in Chennai, India.

ABSTRACT: Background. ?Access to hepatitis C virus (HCV) treatment is limited in low- and middle-income countries (LMICs). Noninvasive biomarkers, such as fibrosis 4 (FIB-4) and aminotransferase to platelet ratio index (APRI), are low-cost alternatives to staging liver disease and identifying treatment need in people with chronic HCV infection, but their accuracy has not been evaluated in LMICs. Methods. ?We tested the accuracy of FIB-4 and APRI at validated cutoffs (FIB-4 <1.45, >3.25; APRI <0.5, >1.5) in predicting severe liver stiffness by elastography among 281 persons chronically infected with HCV. Multivariable logistic and Cox regression were used to identify markers of improved prediction and mortality, respectively. Results. ?Sensitivity and specificity of FIB-4 and APRI for predicting severe stiffness were 62% and 87% and 61% and 83%, respectively. Fibrosis 4 and APRI were less accurate in excluding significant stiffness; however, performance of models significantly improved with ?-glutamyl transpeptidase (GGT) and body mass index (BMI) (area under receiver operating characteristic curve, 0.81; 95% confidence interval, .76-.87). Severe liver stiffness predicted via FIB-4 >3.25, APRI >1.5, and a modified FIB-4 that included GGT and BMI were significantly associated with increased mortality. Conclusions. ?Fibrosis 4 and APRI may be useful in identifying individuals with severe stiffness who need treatment and continued monitoring in LMICs. Exclusion of significant stiffness may be improved by including GGT and BMI to FIB-4 models.

SUBMITTER: Cepeda JA

PROVIDER: S-EPMC5047433 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Serum Fibrosis Markers for the Diagnosis of Liver Disease Among People With Chronic Hepatitis C in Chennai, India.

Cepeda Javier A JA Solomon Sunil S SS Srikrishnan Aylur K AK Nandagopal Paneerselvam P Balakrishnan Pachamuthu P Kumar Muniratnam S MS Thomas David L DL Sulkowski Mark S MS Mehta Shruti H SH

Open forum infectious diseases 20160723 3

Background. Access to hepatitis C virus (HCV) treatment is limited in low- and middle-income countries (LMICs). Noninvasive biomarkers, such as fibrosis 4 (FIB-4) and aminotransferase to platelet ratio index (APRI), are low-cost alternatives to staging liver disease and identifying treatment need in people with chronic HCV infection, but their accuracy has not been evaluated in LMICs. Methods. We tested the accuracy of FIB-4 and APRI at validated cutoffs (FIB-4 <1.4 ...[more]

PMID: 27704012

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Project description:OBJECTIVES:The aim of this study was to explore the association of serum fibrosis marker levels with the risk of clinical and histological disease progression in a large cohort of patients with chronic hepatitis C (CHC). METHODS:462 prior non-responders to peginterferon and ribavirin enrolled in the randomised phase of the Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial had baseline and annual serum samples tested for hyaluronic acid (HA), N-terminal peptide of procollagen type 3, tissue inhibitor of matrix metalloproteinase-1 (TIMP-1) and YKL-40. All patients underwent a pretreatment liver biopsy and follow-up biopsies at years 2 and 4. Histological progression was defined as a ?2 point increase in Ishak fibrosis score in patients without cirrhosis. Clinical outcomes included development of decompensation, hepatocellular cancer, death or an increase in the CTP (Child-Turcotte-Pugh) score to ?7. RESULTS:Mean patient age was 49.5 years and 39% had histological cirrhosis at entry. Baseline HA, YKL-40 and TIMP-1 levels combined with other laboratory parameters were all significantly associated with clinical outcomes in the 69 (15%) patients with disease progression (p<0.0001). The best multivariate model to predict clinical outcomes included baseline bilirubin, albumin, international normalised ratio (INR) and YKL-40 levels. All of the baseline serum fibrosis marker levels were also significantly associated with histological fibrosis progression that developed in 70 (33%) of the 209 patients with cirrhosis (p <0.0001). However, baseline HA and platelet counts were best at predicting histological progression (area under the curve (AUC)=0.663). CONCLUSION:Pretreatment serum fibrosis marker levels are significantly increased in patients with CHC at risk of clinical and histological disease progression. If validated in additional cohorts, measurement of these markers could help identify patients with CHC who would benefit from more frequent and intensive monitoring.

Project description:BACKGROUND:Little is known regarding barriers to hepatitis C virus (HCV) treatment among people who inject drugs (PWID) in low-resource settings, particularly in the era of direct-acting antiviral therapies. METHODS:Between March, 2015-August, 2016, a cross-sectional survey was administered to community-based PWID in Chennai, India to examine the HCV care continuum and associated barriers. Adjusted prevalence ratios (APR) were estimated by multivariable Poisson regression with robust variance. RESULTS:All participants were male (n?=?541); 152 participants had HCV mono-infection and 61 participants had HIV/HCV co-infection. Only one HCV mono-infected and one HIV/HCV co-infected participant was linked to HCV care. Overall, there was moderate knowledge of HCV disease but poor knowledge of HCV treatment. Higher total knowledge scores were negatively associated with HIV/HCV co-infection (vs. HCV mono-infection), though this was not statistically significant in adjusted analysis (APR?=?0.71 [95%CI?=?0.47-1.06]). Participants ?45 years (APR?=?0.73 [95%CI?=?0.58-0.92]) and participants with HIV/HCV co-infection (APR?=?0.64 [95%CI?=?0.47-0.87]) were less willing to take weekly interferon injections for 12 weeks. Willingness to undergo HCV treatment improved with decreasing duration of therapy, higher perceived efficacy, and use of pills vs. interferon, though willingness to use interferon improved with decreasing duration of therapy. Most participants preferred daily visits to a clinic for HCV treatment versus receiving a month's supply. Participants ?45 years (vs. <45?years; APR?=?0.70 [95%CI?=?0.56-0.88]) and participants with HIV/HCV co-infection (APR?=?0.75 [95%CI?=?0.57-0.98]) were less likely to intend on seeking HCV care. Common reasons for not having already seen a provider for HCV treatment differed by HIV status, and included low perceived need for treatment (HCV-mono-infected), competing money/health priorities and costs/fears about treatment (HIV/HCV-co-infected). CONCLUSION:Residual gaps in HCV knowledge and continuing negative perceptions related to interferon-based therapy highlight the need to scale-up educational initiatives. Readiness for HCV treatment was particularly low among HIV/HCV co-infected and older PWID, emphasizing the importance of tailored treatment strategies.

Project description:BackgroundThe accurate assessment of liver fibrosis is essential for patients with chronic liver disease. A liver biopsy is an invasive procedure that has many potential defects and complications. Therefore, noninvasive assessment techniques are of considerable value for clinical diagnosis. Liver and spleen magnetic resonance elastography (MRE) and serum markers have been proposed for quantitative and noninvasive assessment of liver fibrosis. This study aims to compare the diagnostic performance of liver and spleen stiffness measured by MRE, fibrosis index based on the 4 factors (FIB-4), aspartate aminotransferase-to-platelet ratio index (APRI), and their combined models for staging hepatic fibrosis.MethodsOne hundred and twenty patients with chronic liver disease underwent MRE scans. Liver and spleen stiffness were measured by the MRE stiffness maps. Serum markers were collected to calculate FIB-4 and APRI. Liver biopsies were used to identify pathologic grading. Spearman’s rank correlation analysis evaluated the correlation between the parameters and fibrosis stages. Receiver operating characteristic (ROC) analysis evaluated the performance of the four individual parameters, a liver and spleen stiffness combined model, and an all-parameters combined model in assessing liver fibrosis.ResultsLiver stiffness, spleen stiffness, FIB-4, and APRI were all correlated with fibrosis stage (r=0.87, 0.64, 0.65, and 0.51, respectively, all P<0.001). Among the 4 individual diagnostic markers, liver stiffness showed the highest values in staging F1–4, F2–4, F3–4 and F4 (AUC =0.89, 0. 97, 0.95, and 0.95, all P<0.001). The AUCs of the liver and spleen stiffness combined model in the F1–4, F2–4, F3–4, and F4 staging groups were 0.89, 0.97, 0.95, and 0.96, respectively (all P<0.001). The corresponding AUCs of the all-parameters combined model were 0.90, 0.97, 0.95, and 0.96 (all P<0.001). The AUCs of the liver and spleen stiffness combined model were significantly higher than those of APRI, FIB-4 in the F2–4, F3–4, and F4 staging groups (all P<0.05). Both combined models were not significantly different from liver stiffness in staging liver fibrosis (all P>0.05).ConclusionsLiver stiffness measured with MRE had better diagnostic performance than spleen stiffness, APRI, and FIB-4 for fibrosis staging. The combined models did not significantly improve the diagnostic value compared with liver stiffness in staging fibrosis.

Project description:Chronic hepatitis B (CHB) virus continues to be a leading cause of morbidity and mortality worldwide. The diagnosis of liver fibrosis has a key role in selecting patients with CHB for antiviral treatment. However, serum biomarkers demonstrate limited diagnostic utility. The present study aimed to compare the performances of fibrosis biomarkers for diagnosing significant liver fibrosis that indicates the need for antiviral therapy in patients with CHB and to identify the most appropriate biomarker for these patients. The current study included 96 antiviral-naïve patients with CHB who underwent liver biopsy. METAVIR scoring system was used to assess liver fibrosis and necroinflammation. The diagnostic performances were evaluated of the platelet (PLT) count; the levels of hyaluronan, serum 7S domain of type 4 collagen, procollagen type III N-terminal peptide, tissue inhibitor of metalloproteinases 1, Mac-2 binding protein glycosylation isomer (M2BPGi) and N-terminal type III collagen propeptide (Pro-C3); the fibrosis index based on four factors; the aspartate aminotransferase-to-platelet ratio index; and enhanced liver fibrosis score for identifying significant liver fibrosis [?fibrosis stage 2 (F2)]. All fibrosis biomarkers, except the Pro-C3 level, correlated with the fibrosis stage. M2BPGi was better than other biomarkers for diagnosing ?F2, with the highest area under the curve of 0.902. M2BPGi demonstrated a higher diagnostic accuracy for significant fibrosis than mild/severe fibrosis or cirrhosis. However, no significant correlation was observed between the M2BPGi level and fibrosis stage in patients with CHB having significant liver necroinflammation defined as ? necroinflammatory activity 2. The M2BPGi level and PLT count were exclusively correlated with the fibrosis stage in 73 patients without significant liver necroinflammation. M2BPGi demonstrated the highest diagnostic performance for significant fibrosis in patients having significant liver fibrosis with no significant liver necroinflammation. In conclusion, the M2BPGi level can accurately diagnose significant liver fibrosis that indicates the need for antiviral therapy in patients with CHB.

Project description:BackgroundNon-invasive evaluation for liver fibrosis is clinically important, especially in patients with undetectable hepatitis B virus (HBV) DNA treated with nucleoside analogs.AimTo clarify the monitoring power of hepatitis B core-related antigen (HBcrAg) for hepatic histologic changes in patients with chronic hepatitis B (CHB) treated with entecavir.MethodsThis prospective multicenter study used multiple ordinal and multivariate logistics regression analysis to assess variables associated with Ishak fibrosis score and regression for fibrosis regression, respectively, in 403 CHB patients, including 374 with entecavir for 72 weeks (291 underwent paired liver biopsy) and 29 as controls.ResultsLevel of HBcrAg correlated negatively with liver fibrosis staging (γ = -0.357, P < 0.001) in hepatitis B e antigen (HBeAg)-positive patients, and positively with liver fibrosis staging in HBeAg-negative patients. Higher HBcrAg concentration was associated with younger age, HBeAg positive status, high HBV DNA loads, high level of hepatitis B surface antigen (HBsAg) and higher necroinflammation, but not with HBV genotype. Serum concentration of HBcrAg, basal core promoter/precore (BCP/PC) mutant, quantitation of HBsAg (qHBsAg) and platelet counts were independently associated with Ishak fibrosis score on multiple ordinal regression. HBV DNA was undetectable in 88.37% of patients treated with entecavir at week 72, while their level of HBcrAg was still detectable. A greater reduction in post-treatment HBcrAg concentration was associated with the regression of hepatic fibrosis and histological improvement. HBcrAg concentration > 6.33 log IU/mL at baseline and logarithmic reduction > 1.03 log IU/mL at week 72 were associated with a higher chance of regression of liver fibrosis and histological improvement, respectively.ConclusionHBcrAg level is associated with liver fibrosis progression. HBcrAg is an excellent monitor of hepatic histological changes, especially in CHB patients treated with nucleoside analogs.

Dataset Information

Serum Fibrosis Markers for the Diagnosis of Liver Disease Among People With Chronic Hepatitis C in Chennai, India.

Publications

Serum Fibrosis Markers for the Diagnosis of Liver Disease Among People With Chronic Hepatitis C in Chennai, India.

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