- Email: [email protected]
233 Early Detection of Hepatitis C Using a One Minute Visual Qualitative Based Kit System in a Community Based Setting in Doha, Qatar
233
HCC, transplantation, or death. Clinical outcome exclusive of HCC was also evaluated. Histological outcome was defined as an increase in Ishak fibrosis stage of > 2 in patients with noncirrhotic fibrosis at baseline. MDBs were scored as 1 (present) or 0 (absent) on H&E staining by a group of expert hepatopathologists. Results: Of 1050 randomized patients, 158 (15%) had MDBs on baseline biopsy. In univariate analysis, MDBs were significantly associated with insulin resistance, laboratory markers of liver disease severity, and presence of higher scores of fibrosis, steatosis, inflammation, and pericellular fibrosis. There was no association between MDBs and gender, age, race, or alcohol use. In multivariate analysis, low albumin (p=0.001) and high HOMA-IR (p=0.018), AFP (p<0.001), and AST/ALT ratio (p=0.008) were significantly associated with MDBs. Of the 1050 randomized pts, 313 (30%) developed a clinical outcome, including 233 patients (20%) without HCC. MDBs on baseline biopsy were highly associated with all clinical outcomes and non-HCC clinical outcomes (p<0.001), however these associations were not significant (p=0.57 and 0.85 respectively) after adjusting for other baseline disease severity variables (AST/ALT ratio, albumin, platelets, fibrosis stage). Of the 468 patients with noncirrhotic fibrosis on baseline biopsy, 154 (33%) experienced fibrosis progression. MDBs were highly associated with histological outcome (p<0.001), and remained significant even after adjusting for baseline variables associated with fibrosis progression (AST/ALT ratio, albumin, platelets, fibrosis stage, steatosis grade) (p=0.04). Conclusion: MDBs on baseline biopsy of patients with HCV infection are associated with advanced fibrosis and increased risk of fibrosis progression over time, though they do not independently predict clinical decompensation, HCC, death, or transplantation.
AASLD Abstracts
Early Detection of Hepatitis C Using a One Minute Visual Qualitative Based Kit System in a Community Based Setting in Doha, Qatar Manik Sharma, Khalid Matar, Nazeeh Z. Dweik, Saad A. Kaabi, Anil K. John, Muneera A. Mohanadi, Ashraf A. Abdel aziz, Moutaz F. Derbala, Fuad I. Pasic, Mohammed T. Butt, Rafae A. Yaqoob, Rajvir Singh BACKGROUND: Early detection and treatment of Hepatitis C can change the natural history of disease. AIM: The primary aim of this study was to detect infection of hepatitis C using a rapid immunochromatographic assay in a community setting. The secondary aims included assessment of prevalence rate and disease characteristics; including liver function tests, viral load, grade and stage of disease on the liver biopsy. METHODS: Two cohorts of 4000 and 3212 people (.004% of the population) were surveyed over a three week period each between December 2008 through August 2009. Qualitative detection of hepatitis C antibodies was done using a colloidal gold enhanced rapid immunochromatographic assay (Health Chem Diagnostics LLC, FL-USA).Viral load was calculated using RT PCR (Taqman) and those found positive underwent liver biopsy.28 and 33patients with proven chronic hepatitis C formed the controls for validation of the kit used in the first and the second cohort. RESULTS: 64 people were detected to have positive antibodies (0.008%) to hepatitis C (Cohort 1 -33/ 4000, Cohort 2- 31/3212). In the first cohort, among 28 persons with positive antibodies detected with the kit, abnormal LFT were observed in 21 (75 %) and 10 (35.7 %) had more than > 2 ALT levels (Range 17- 174 IU/ml).24 agreed for further testing with RT PCR and another 4 agreed for testing using another method (Enzyme immunoassay).The mean viral load was 5757445 IU/ml (Range 27563- 45448680 IU/ml).Only one person detected to have positive antibodies with the kit was found to have negative HCV PCR. 15 patients (62.5%) who underwent liver biopsy, 9 showed evidence of advanced fibrosis (≥F2) and 7 showed moderate necroinflammation (A 2). 12 patients (50%) undertook standard treatment with Pegylated Interferon and Ribavarin and 8 of them have achieved either rapid or early virological response at the last follow up. The prevalence rate was detected to be 15 per thousand people. The second cohort is under evaluation for further assessment and management. CONCLUSION: The kit test based detection technique for hepatitis C is quite an effective strategy for early detection especially in community based setting. Further large surveillance studies are required to detect this disease for its effective control.
236 Independent Validation of the Safe Biopsy Algorithm: Analysis of the Achieve Cohorts Alexander J. Thompson, Paul J. Clark, Hans L. Tillmann, Michael Torbenson, Erik Pulkstenis, Mani Subramanian, John McHutchison, Keyur Patel Background: The SAFE biopsy algorithm, that uses sequential APRI and FibroTest, has recently been proposed as a non-invasive screening tool for significant fibrosis in HCV carriers (HEPATOLOGY 2009;49:1821). We independently investigated the performance of the SAFE biopsy in chronic HCV patients enrolled in the ACHIEVE-1 and ACHIEVE-2/3 trials. Methods: 2255 treatment-naïve patients with chronic HCV-1 or HCV-2/3 were enrolled in two separate phase 3, active-controlled studies of albinterferon alfa-2b plus ribavirin for 48 or 24 weeks, respectively. Clinical evaluation included age, gender, race, body mass index (BMI), HCV genotype, HCV viral load, ALT, AST, platelet count, insulin resistance (HOMA-IR), FibroTest/FibroSure and baseline liver biopsy evaluated for steatosis, METAVIR grade and fibrosis by a single pathologist. Standard APRI and FibroTest cut-offs were applied for stage F2-4 and F4. Statistical analysis was performed using SAS 9.1 Results: Baseline fibrosis prevalence in the ACHIEVE cohort was: F0 (794, 35.8%), F1 (1005, 45.3%), F2 (182, 8.2%), F3 (116, 5.2%) and F4 (124, 5.6%). The prevalence of significant fibrosis (METAVIR F2-4) was therefore lower than in the published SAFE cohort was (19.9% vs 46.7%, P-value <0.001). The SAFE biopsy identified F2-4 with 83% accuracy. 626/2161 (29%) patients avoided having a liver biopsy. However, of these 626 patients, 357 (57%) were misclassified as F2-4. The SAFE biopsy identified cirrhosis (F4) with 92% accuracy, and biopsy was avoided in 96% of patients. Conclusion: In this independent validation, the performance characteristics of the SAFE biopsy were good for identifying the presence of cirrhosis, and most patients would have avoided liver biopsy. However, in this cohort, the SAFE biopsy was less accurate for diagnosing F2-4 fibrosis, most patients would still have required a liver biopsy, and the misclassification rate of patients not undergoing liver biopsy was high.
234 A Prospective Evaluation by Paired Liver Biopsy of Fibrosis Progression in HIV-HCV Coinfection Compared to HCV Monoinfection Richard K. Sterling, Jacob A. Wegelin, Paula G. Smith, Velimir A. Luketic, R. Todd Stravitz, Michael Fuchs, Puri Puneet, Mitchell L. Shiffman, Arun J. Sanyal Background and Aims: Fibrosis progression may be accelerated in HIV/HCV coinfection. However, no studies have directly compared fibrosis progression by paired liver biopsy (LB) in HIV-HCV coinfection and HCV monoinfection. We performed a prospective longitudinal cohort study to compare fibrosis progression by paired LB in patients with HIV/HCV and HCV alone and assessed factors associated with progression. Methods: HIV/HCV and HCV monoinfected patients with paired LB were matched by initial fibrosis stage, demographics, and HCV treatment. Clinical and laboratory data were obtained at the time of LB and at intervening visits every 3-6 months in those with coinfection. Histology was assessed for inflammation, fibrosis and steatosis. In coinfected patients, categorical variables at baseline and area under the curve (AUC) of continuous variables per unit time were analyzed respectively for association with fibrosis progression by the fisher exact and rank sum tests. Results: Of 298 coinfected patients with LB, 56 without sustained virologic response (SVR) or cirrhosis at baseline had paired LB and were matched to HCV controls. The mean (±SD) age was 44(8) yrs, AST 91(70), ALT 93(68) U/L, CD4 571(433), 41% had HIV < 400 copies/ ml, and 79% were on HAART (NRTI in 75%, NNRTI in 24%, and PI in 49%). Coinfected patients had higher piecemeal necrosis (p=.001), lobular inflammation (p=.002) and shorter interval (yrs) between LB (4.7 vs. 5.9, p<.0001). Between 1st and 2nd LB, fibrosis remained unchanged in 55%, progressed 1 unit in 18% and 2 units in 18% in coinfected patients compared to 45%, 30% and 9% in HCV controls, respectively (NS). The fibrosis progression rate was also similar between HIV/HCV and HCV alone (0.13 ± 0.4 vs. 0.064 ± 0.27 units/ yr; p=.72). In 62 HIV/HCV patients with paired LB including those with SVR, there were no associations between fibrosis progression and demographics, baseline or changes in CD4, AST or ALT, HAART use, response to HCV therapy (no treatment, SVR, or non-response), baseline FIB-4 or histology including inflammation, fibrosis, or steatosis. Conclusions: When matched for baseline fibrosis, fibrosis progression is similar in HIV/HCV coinfection and HCV monoinfection. The previous reports of rapid disease progression may have been biased by patient selection in the early HAART era. Because there were no clinical or laboratory parameters that predicted disease progression, all coinfected patients should be considered for repeat assessment of disease severity by LB at periodic intervals in order to identify those who progress.
237 Progression of Advanced Chronic Hepatitis C (CHC): Further Follow-up Results From the Halt-C Trial Jules L. Dienstag, Herbert L. Bonkovsky, Hae-Young Kim, Leonard B. Seeff, Adrian M. Di Bisceglie, Gyongyi Szabo, Elizabeth C. Wright Background: In advanced chronic hepatitis C (CHC), rate of progression has been derived primarily from retrospective analyses. Recent results from the HALT-C Trial [NEJM 2008;359:2429,] showed that long-term, low-dose pegylated interferon therapy was not effective in preventing progression or death. Thus, the combined HALT-C cohort, followed prospectively for a median of 5.6 (up to 8) years, provided a unique opportunity to assess disease progression in a large, prospectively followed population. Aim: To characterize progression of clinical decompensation and laboratory abnormalities in subjects in the HALTC Trial. Methods: We analyzed results of 1,050 subjects, 622 (60%) with non-cirrhotic fibrosis and 428 (40%) with cirrhosis at baseline. Protocol-defined outcomes included Child-Turcotte-Pugh (CTP) score ≥7 on two consecutive study visits, ascites, hepatocellular carcinoma (HCC), variceal bleeding, encephalopathy, bacterial peritonitis, or death. Additional threshold laboratory values for assessing progression were: creatinine ≥1.2 mg/dL, bilirubin ≥1.5 mg/dL, INR ≥1.5, albumin ≤3g/dL, AST/ALT ≥1, and MELD score ≥15. Kaplan-Meier life-table analyses and log-rank tests were used to compare times of outcomes and derived Cox proportional hazards models to estimate risks of first outcomes. Results: 286 initial clinical outcomes occurred, 105 (3.4% per year, 23.5% cumulative) in the fibrosis and 181 (7.4% per year, 51.7% cumulative) in the cirrhosis stratum (p<0.0001). Among initial outcomes, CTP ≥7 was most frequent, 12.1%; followed by death, 4.6% (only 1.2% were liver-related); HCC, 4.2%; ascites, 3.3%; encephalopathy, 1.7%; and variceal hemorrhage,1.3%. The earliest and most frequent laboratory abnormality was AST/ALT≥1, followed by elevated bilirubin and reduced albumin. Rises in CTP to ≥7 occurred 4 times more frequently in the cirrhotic than the fibrosis stratum (22.0% vs 5.3%), whereas rates of liverrelated death (1.4% vs 1.0%) and HCC (4.7% vs 3.8%) were similar. Outcomes increased
235 Clinical Correlates and Prognostic Value of Mallory-Denk Bodies in Hepatitis C: Analysis of the Halt-C Cohort Mina O. Rakoski, Morton B. Brown, Robert J. Fontana, Herbert L. Bonkovsky, Anna S. Lok, Bishr Omary Background: Mallory-Denk bodies (MDBs) are hepatocyte inclusions found in several chronic liver diseases. Mouse models of MDBs have highlighted essential determinants for their formation including gender and genetic background. The significance of MDBs in human liver disease severity or progression is not understood. Aims: Identify clinical features associated with MDBs in patients with HCV infection and evaluate their role in clinical and histological disease progression. Methods: Data from 1050 patients randomized in the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) trial was analyzed using univariate analysis and logistic regression. Clinical outcome was defined as ascites, CTP score >7 on two occasions, bacterial peritonitis, encephalopathy, variceal bleeding,
AASLD Abstracts
S-780
HCC, transplantation, or death. Clinical outcome exclusive of HCC was also evaluated. Histological outcome was defined as an increase in Ishak fibrosis stage of > 2 in patients with noncirrhotic fibrosis at baseline. MDBs were scored as 1 (present) or 0 (absent) on H&E staining by a group of expert hepatopathologists. Results: Of 1050 randomized patients, 158 (15%) had MDBs on baseline biopsy. In univariate analysis, MDBs were significantly associated with insulin resistance, laboratory markers of liver disease severity, and presence of higher scores of fibrosis, steatosis, inflammation, and pericellular fibrosis. There was no association between MDBs and gender, age, race, or alcohol use. In multivariate analysis, low albumin (p=0.001) and high HOMA-IR (p=0.018), AFP (p<0.001), and AST/ALT ratio (p=0.008) were significantly associated with MDBs. Of the 1050 randomized pts, 313 (30%) developed a clinical outcome, including 233 patients (20%) without HCC. MDBs on baseline biopsy were highly associated with all clinical outcomes and non-HCC clinical outcomes (p<0.001), however these associations were not significant (p=0.57 and 0.85 respectively) after adjusting for other baseline disease severity variables (AST/ALT ratio, albumin, platelets, fibrosis stage). Of the 468 patients with noncirrhotic fibrosis on baseline biopsy, 154 (33%) experienced fibrosis progression. MDBs were highly associated with histological outcome (p<0.001), and remained significant even after adjusting for baseline variables associated with fibrosis progression (AST/ALT ratio, albumin, platelets, fibrosis stage, steatosis grade) (p=0.04). Conclusion: MDBs on baseline biopsy of patients with HCV infection are associated with advanced fibrosis and increased risk of fibrosis progression over time, though they do not independently predict clinical decompensation, HCC, death, or transplantation.
AASLD Abstracts
Early Detection of Hepatitis C Using a One Minute Visual Qualitative Based Kit System in a Community Based Setting in Doha, Qatar Manik Sharma, Khalid Matar, Nazeeh Z. Dweik, Saad A. Kaabi, Anil K. John, Muneera A. Mohanadi, Ashraf A. Abdel aziz, Moutaz F. Derbala, Fuad I. Pasic, Mohammed T. Butt, Rafae A. Yaqoob, Rajvir Singh BACKGROUND: Early detection and treatment of Hepatitis C can change the natural history of disease. AIM: The primary aim of this study was to detect infection of hepatitis C using a rapid immunochromatographic assay in a community setting. The secondary aims included assessment of prevalence rate and disease characteristics; including liver function tests, viral load, grade and stage of disease on the liver biopsy. METHODS: Two cohorts of 4000 and 3212 people (.004% of the population) were surveyed over a three week period each between December 2008 through August 2009. Qualitative detection of hepatitis C antibodies was done using a colloidal gold enhanced rapid immunochromatographic assay (Health Chem Diagnostics LLC, FL-USA).Viral load was calculated using RT PCR (Taqman) and those found positive underwent liver biopsy.28 and 33patients with proven chronic hepatitis C formed the controls for validation of the kit used in the first and the second cohort. RESULTS: 64 people were detected to have positive antibodies (0.008%) to hepatitis C (Cohort 1 -33/ 4000, Cohort 2- 31/3212). In the first cohort, among 28 persons with positive antibodies detected with the kit, abnormal LFT were observed in 21 (75 %) and 10 (35.7 %) had more than > 2 ALT levels (Range 17- 174 IU/ml).24 agreed for further testing with RT PCR and another 4 agreed for testing using another method (Enzyme immunoassay).The mean viral load was 5757445 IU/ml (Range 27563- 45448680 IU/ml).Only one person detected to have positive antibodies with the kit was found to have negative HCV PCR. 15 patients (62.5%) who underwent liver biopsy, 9 showed evidence of advanced fibrosis (≥F2) and 7 showed moderate necroinflammation (A 2). 12 patients (50%) undertook standard treatment with Pegylated Interferon and Ribavarin and 8 of them have achieved either rapid or early virological response at the last follow up. The prevalence rate was detected to be 15 per thousand people. The second cohort is under evaluation for further assessment and management. CONCLUSION: The kit test based detection technique for hepatitis C is quite an effective strategy for early detection especially in community based setting. Further large surveillance studies are required to detect this disease for its effective control.
236 Independent Validation of the Safe Biopsy Algorithm: Analysis of the Achieve Cohorts Alexander J. Thompson, Paul J. Clark, Hans L. Tillmann, Michael Torbenson, Erik Pulkstenis, Mani Subramanian, John McHutchison, Keyur Patel Background: The SAFE biopsy algorithm, that uses sequential APRI and FibroTest, has recently been proposed as a non-invasive screening tool for significant fibrosis in HCV carriers (HEPATOLOGY 2009;49:1821). We independently investigated the performance of the SAFE biopsy in chronic HCV patients enrolled in the ACHIEVE-1 and ACHIEVE-2/3 trials. Methods: 2255 treatment-naïve patients with chronic HCV-1 or HCV-2/3 were enrolled in two separate phase 3, active-controlled studies of albinterferon alfa-2b plus ribavirin for 48 or 24 weeks, respectively. Clinical evaluation included age, gender, race, body mass index (BMI), HCV genotype, HCV viral load, ALT, AST, platelet count, insulin resistance (HOMA-IR), FibroTest/FibroSure and baseline liver biopsy evaluated for steatosis, METAVIR grade and fibrosis by a single pathologist. Standard APRI and FibroTest cut-offs were applied for stage F2-4 and F4. Statistical analysis was performed using SAS 9.1 Results: Baseline fibrosis prevalence in the ACHIEVE cohort was: F0 (794, 35.8%), F1 (1005, 45.3%), F2 (182, 8.2%), F3 (116, 5.2%) and F4 (124, 5.6%). The prevalence of significant fibrosis (METAVIR F2-4) was therefore lower than in the published SAFE cohort was (19.9% vs 46.7%, P-value <0.001). The SAFE biopsy identified F2-4 with 83% accuracy. 626/2161 (29%) patients avoided having a liver biopsy. However, of these 626 patients, 357 (57%) were misclassified as F2-4. The SAFE biopsy identified cirrhosis (F4) with 92% accuracy, and biopsy was avoided in 96% of patients. Conclusion: In this independent validation, the performance characteristics of the SAFE biopsy were good for identifying the presence of cirrhosis, and most patients would have avoided liver biopsy. However, in this cohort, the SAFE biopsy was less accurate for diagnosing F2-4 fibrosis, most patients would still have required a liver biopsy, and the misclassification rate of patients not undergoing liver biopsy was high.
234 A Prospective Evaluation by Paired Liver Biopsy of Fibrosis Progression in HIV-HCV Coinfection Compared to HCV Monoinfection Richard K. Sterling, Jacob A. Wegelin, Paula G. Smith, Velimir A. Luketic, R. Todd Stravitz, Michael Fuchs, Puri Puneet, Mitchell L. Shiffman, Arun J. Sanyal Background and Aims: Fibrosis progression may be accelerated in HIV/HCV coinfection. However, no studies have directly compared fibrosis progression by paired liver biopsy (LB) in HIV-HCV coinfection and HCV monoinfection. We performed a prospective longitudinal cohort study to compare fibrosis progression by paired LB in patients with HIV/HCV and HCV alone and assessed factors associated with progression. Methods: HIV/HCV and HCV monoinfected patients with paired LB were matched by initial fibrosis stage, demographics, and HCV treatment. Clinical and laboratory data were obtained at the time of LB and at intervening visits every 3-6 months in those with coinfection. Histology was assessed for inflammation, fibrosis and steatosis. In coinfected patients, categorical variables at baseline and area under the curve (AUC) of continuous variables per unit time were analyzed respectively for association with fibrosis progression by the fisher exact and rank sum tests. Results: Of 298 coinfected patients with LB, 56 without sustained virologic response (SVR) or cirrhosis at baseline had paired LB and were matched to HCV controls. The mean (±SD) age was 44(8) yrs, AST 91(70), ALT 93(68) U/L, CD4 571(433), 41% had HIV < 400 copies/ ml, and 79% were on HAART (NRTI in 75%, NNRTI in 24%, and PI in 49%). Coinfected patients had higher piecemeal necrosis (p=.001), lobular inflammation (p=.002) and shorter interval (yrs) between LB (4.7 vs. 5.9, p<.0001). Between 1st and 2nd LB, fibrosis remained unchanged in 55%, progressed 1 unit in 18% and 2 units in 18% in coinfected patients compared to 45%, 30% and 9% in HCV controls, respectively (NS). The fibrosis progression rate was also similar between HIV/HCV and HCV alone (0.13 ± 0.4 vs. 0.064 ± 0.27 units/ yr; p=.72). In 62 HIV/HCV patients with paired LB including those with SVR, there were no associations between fibrosis progression and demographics, baseline or changes in CD4, AST or ALT, HAART use, response to HCV therapy (no treatment, SVR, or non-response), baseline FIB-4 or histology including inflammation, fibrosis, or steatosis. Conclusions: When matched for baseline fibrosis, fibrosis progression is similar in HIV/HCV coinfection and HCV monoinfection. The previous reports of rapid disease progression may have been biased by patient selection in the early HAART era. Because there were no clinical or laboratory parameters that predicted disease progression, all coinfected patients should be considered for repeat assessment of disease severity by LB at periodic intervals in order to identify those who progress.
237 Progression of Advanced Chronic Hepatitis C (CHC): Further Follow-up Results From the Halt-C Trial Jules L. Dienstag, Herbert L. Bonkovsky, Hae-Young Kim, Leonard B. Seeff, Adrian M. Di Bisceglie, Gyongyi Szabo, Elizabeth C. Wright Background: In advanced chronic hepatitis C (CHC), rate of progression has been derived primarily from retrospective analyses. Recent results from the HALT-C Trial [NEJM 2008;359:2429,] showed that long-term, low-dose pegylated interferon therapy was not effective in preventing progression or death. Thus, the combined HALT-C cohort, followed prospectively for a median of 5.6 (up to 8) years, provided a unique opportunity to assess disease progression in a large, prospectively followed population. Aim: To characterize progression of clinical decompensation and laboratory abnormalities in subjects in the HALTC Trial. Methods: We analyzed results of 1,050 subjects, 622 (60%) with non-cirrhotic fibrosis and 428 (40%) with cirrhosis at baseline. Protocol-defined outcomes included Child-Turcotte-Pugh (CTP) score ≥7 on two consecutive study visits, ascites, hepatocellular carcinoma (HCC), variceal bleeding, encephalopathy, bacterial peritonitis, or death. Additional threshold laboratory values for assessing progression were: creatinine ≥1.2 mg/dL, bilirubin ≥1.5 mg/dL, INR ≥1.5, albumin ≤3g/dL, AST/ALT ≥1, and MELD score ≥15. Kaplan-Meier life-table analyses and log-rank tests were used to compare times of outcomes and derived Cox proportional hazards models to estimate risks of first outcomes. Results: 286 initial clinical outcomes occurred, 105 (3.4% per year, 23.5% cumulative) in the fibrosis and 181 (7.4% per year, 51.7% cumulative) in the cirrhosis stratum (p<0.0001). Among initial outcomes, CTP ≥7 was most frequent, 12.1%; followed by death, 4.6% (only 1.2% were liver-related); HCC, 4.2%; ascites, 3.3%; encephalopathy, 1.7%; and variceal hemorrhage,1.3%. The earliest and most frequent laboratory abnormality was AST/ALT≥1, followed by elevated bilirubin and reduced albumin. Rises in CTP to ≥7 occurred 4 times more frequently in the cirrhotic than the fibrosis stratum (22.0% vs 5.3%), whereas rates of liverrelated death (1.4% vs 1.0%) and HCC (4.7% vs 3.8%) were similar. Outcomes increased
235 Clinical Correlates and Prognostic Value of Mallory-Denk Bodies in Hepatitis C: Analysis of the Halt-C Cohort Mina O. Rakoski, Morton B. Brown, Robert J. Fontana, Herbert L. Bonkovsky, Anna S. Lok, Bishr Omary Background: Mallory-Denk bodies (MDBs) are hepatocyte inclusions found in several chronic liver diseases. Mouse models of MDBs have highlighted essential determinants for their formation including gender and genetic background. The significance of MDBs in human liver disease severity or progression is not understood. Aims: Identify clinical features associated with MDBs in patients with HCV infection and evaluate their role in clinical and histological disease progression. Methods: Data from 1050 patients randomized in the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) trial was analyzed using univariate analysis and logistic regression. Clinical outcome was defined as ascites, CTP score >7 on two occasions, bacterial peritonitis, encephalopathy, variceal bleeding,
AASLD Abstracts
S-780