application of telemedicine in the management of chronic hepatitis c in texas prisons

1
",,,,ere retrospectively reviewed. Patients with other liver diseases, on immunosuppressive therapy, or had prior trat)splants were exclu&d. Hepatic fibrosis was assessed blindly by one pathologist using the ishak score. Significant fibrosis was defined as Ishak score ->3 and cirrhosis >-5. Clinical and laboratory variables for patients with and without significant fibrosis and cirrhosis were tested by uinvariate and multivariate analysis to construct one model that would predict both significant fibrosis and cirrhosis. Results 205 patients were included in the study, 133(65%)men, mean age 46years. 109(53%) patients had lshak score 0-2, 65(32%) lshak 3-4 and 31(15%) Ishak 5-6. The best model for predicting significant hbrosis included INR, platelets and AST, with an area under ROC curve (AROO of 0.79. \121ebest model for predicting cirrhosis included ALT, platelets, AST/ALT ratio, with AROC of 0.92. Progression of fibrosis was associated with rise in AST and drop in platelets. Hence, a novel index (AST Platelet Ratio Index, APRI) was created by dividing AST(xULN) by platelets(k/mm~), and multiplying by 100. AROC of APRl for predicting significant fibrosis and cirrhosis were 080 and 0.90, respectively (see graph). Using the APRI, a score of -<0.5 ~ld NPV ot 85% tor sigmficant tibrosis, and a score of -<2.0 had NPV of 93% for cirrhosis. Conclusion A single, novel in&x using readily available laboratory data was accurate in excluding both significant fibrosis and cirrhosis in 29% and 85% of the study population, respectively. Application of this index may decrease the need for liver biopsy among CHC patiems. ROC curve of APRI 0 0,2 0.4 0.6 0.8 t 1 - specificAy T1264 Application of Telemedicine in the Management of Chronic Hepatitis C in Texas Prisons Daryl T.-Y. Lau, Syed Fehmi, Darlene Sit:uentes Background and Aim: The HCV seroprevalence was estimated to be 29% m the Texas prisons. A standardized HCV treatment algorittml was implemented in }-ear 2000. Since there were over 100 prison units in the state, Telemediciue clinics were utilized for this initiative. An intense HCV education program was provided to die health personnel from the umts prior to the launch of the HCV program. The aim of this study was to summarize our experience applying Telemedicme in managing dmmic HCV in the correctional setting. Methods: The HC%' treatment protocol tbllowed closely to the standard of care in the commmfities. Siilce psychiatric problems were common in this population, patients with history of mental illnesses were evaluated prior to therapy. Those qualified for therapy' and had sentence louger ttran 18 months were asked to sign an informed consent form to ensure their compliance. At screening, tim unit physicians discussed with the hepatologists about the medical conditions arid lafioratoW results of the patients via Telemedicine. The candidates were started on intert~ron-alpha 2a 3MU SC tiw with weight-based nbavirin (1-1.2 g) daily. Treatment duration was dependent on HC_~," genotype: Max. 48 wks for genotype 1 and 24 wks tbr genotype non-l. Throughout the treatment period, regular Tehemedicine cliincs were scheduled between the unit phy'sicians and the specialists to discuss the side effects and laboratory resuhs profiles. Remlts: To date, 470 treatment patients completed at least 6 months of therapy. Among them, there were 52% W~ites (W), 18% African Americans (AM) and 30% Hispanics (Hi. H(N genoty~ 1 was more frequent among A~rican Americans compared to the other two races (AM=95% vs W= 66% vs. H=67%). The overall virological response for genotypel patients at 6 months was 33%. Them were, however, significant ditterencen between the races: W=42% es. B=22% vs. H=33%. Among the genotype non-1 patients, 71% had end~ofLtreatmem virological respouse. 58 (13%) patients had premature discontinuation of therapy due to side effects (4%), non-compliance (4.5%) and early parole (45%) An additional 28 (6%) had dose reduction due to anemia and neutropenia. Conclusion: Based on this preliminary analysis, HCV can be successfully" man- aged in tim complex prison system ntilizing Telcmedicine. There were comparable rates of respoilse and side effects as in the general communities. Carefi.d patient screening and close monitoring are critically important to ensure compliance and to detect early adverse events m this population. T1265 Study of Relationship Between Upper Gastrointestinal Bleeding and Hepato Renal Failure in Cirrhosis Ashraf R. Abulfutuh, Mohammed Morsy, Abd E1 Ghany Solyman, Said El Hendav, T, Mohammed El Desouky, Salwa El Hadad, Moemena Kamel Background:Gastrointestinal bleeding (GIB) has been classically consi&red as a precipitating factor of hepato renal failure in patients with cirrhosis.Aim: This study was aimed at assessing the incidence ,clinical course , predictive factors and prognosis of bepato renal Mlure in patients with cirrhosis and GIB Methods:One-hmadred and seventy-five cortsecutive episodes of GIB in 161 patients with cirrhosis were analyzed .A control group of patients with GIB without cirrhosis matched by age and intensity of the bleeding was analyzed for comparison .Thirty-one clinical and laboratory variables obtained at admission or during hospitalization related with the bleeding episode or with liver and renal function were analyzed as possible predictors of hepato renal failure and in-hospital mortality in patients with cirrhosis .Results: Hepato renal failure occurred in 20 (11%) episo&s in patients with cirrhosis compared to only one (1%) in patients without cirrhosis (p<0.05).In patients v,,ith cirrhosis hepato renal failure fbllowed a progressive course in 10 episodes ,steady"in 5 and transient in 5. In 7 of the 20 episodes.(35%), hepato re)lal failure was associated with ischemic hepatitis. In&pendent predictors of bepato renal failure in patients with cirrhosis were the presence of shock, number of packed red blood cells transfused ,Child Pugh class at admission, and baseline platelet count. Sixteen patients with cirrhosis (9%) died during hospitalization .The develop- ment of bepato renal failure and shock were the only in&pen&nt predictors of mortality,Co> clusion:Hepato renal failure is a relatively- common event in patients with cirrhosis and GIB, the occurrence of which is mainly related to tbe severity of bleeding and baselin liver function. Hepato renal failure is a strong predictor of mortality, better than liver failure in patients with cirrhosis and GIB. The presence of cirrhosis predisposes to the development of hepato renal failure after G1B. T1266 Escalation of Interferon and Ribavirin for Recurrent Hepatitis C after Liver Transplantation: Increasing Adherence to Therapy Nazir Rahim, Katherine Suggett, Christoph Troppmann, Colette Chambers, John McVicar, Lorenzo Rossaro Background: Hepatitis C virus (HCV) treatment after liver transplantation (LT) has been difficult. The reported drop out rates range from 22%-50% with combination interleron (INF) and ribavirin (RBV) therapy. Main reasons for discontinuation are bone marrow toxicity and hemolytic anemia. Aim: To use escalating doses of IFN and RBV in COl~}unction with growth factors to prevent dose reduction and enhance adherence. Methods: We prospectivdy analyzed data tu ten patients (90% male, mean age 48 years, 60% genotype 1, primary immunosuppression with tacrolimus and prednisone) with biopsy proven recurrent HCX/" after LT. IFN dosing started at 1 M1U tiw, increased by 0.5 MIU biweekly to a maximum dose of 3 MILl tiw. RBV dosing started at 200 mg bid, increased by 200 mg biweekly to >- 10 mg/kg/day with intention to treat for 48 weeks. Weekly filgrastim (median: 900, range 300-2400 units) and erythropoietin (20-40 x 103 units) doses were utilized once absolute nentrophil count (ANO or hemoglobin (Hgb) levels dropped below 1.0 xlO3/mm3 or ]lg dl, respectively, with goal to keep ANC above 1.5 xl07mm 3 and Hgb above 10 g/dl. Results: To date, 9 of 10 patients completed 24 weeks of therapy. One patient dropped out of study' prior to 24 weeks of therapy due to hepatic &compensation. All patients achieved -> 80% of target doses at 12 weeks. 70% of patients required filgrasmn or erythropoietin by 8 and 12 weeks, respectively ANC remained stable (baseline: 3.91 -+2.7 12 weeks: 4.2-+3.4; 24 weeks: 3.5_+27 xlO3/mm3, p=NS) and Hgb dropped (baseline: 149+-2.1; 12 weeks: 126 -+ 1.3; 24 weeks 11.6 -+ 1.5 g/dl, p<O.05), but their levels were maintained above target by" using growth factors with less than 20% reduction in doses of IFN and RBV Three of 9 patients achieved viral clearance at 24 weeks with negatis'e qualitative HCV-RNA. Conclu- sion: Our preliminary data suggest that escalating doses of IFN and RBV and early use 0[ growth tactors allow ->80% adharence to therapy in patients with recurrent HCV alier LT. T1267 Significant Percentage Of Normal ALT Values seen in Chronic HCV infected patients at a VA Medical Center. Venkat Raugaraj Often the diagnosis of HCV infection is confirmed after abnormalities are seen m biochemical tests fbr liver injury-, i.e. ALT (alanina aminotransferase). Some have proposed that a uormal ALT indicates minimal or no liver injury. This is diflkult to &tennine in a disease, which is characterized by slow non-linear progression. This study" was undertaken to turther clarify the significance of normal ALT m veterans with active chronic HCV infection. Methods: Eighty sex'en HCW positive outpatients referred for treatment at the VA Medical Center Cincinnati were studied prospectively, lh'e-treatmem laboratory" tests included ALT levds, viral genotypes and HCV-RNA loads were obtained on every patient. Patients with established disease were treated with interferon alpha 2b or Pegylated interteron alpha 2b in combination with Ribavirin using generally accepted protocols Serum HCV-RNA levels were obtained at 0, 3, 6, 12 months alter initiating treaunent and again at 18 months (6 months pnsl treatment). Pre-treatment liver biopsy to stage the fibrosis was performed on every patient Treatment was not initiated on any patient if consumption of alcohol was observed in the preceding 3 month period. We then compared the follov, ing 7 variables (race, age, virolo~" genotype, nntntinn, biopsy result and response to treatment) of each of the two clinical groups, (normal vs elevated ALT levels). Results: From a pool of 87 patients (85 males 2 females), we identified 29 patients (33.33%) with normal serum ALT (<50 IU~) and 58 patients (6667%) with >50 IU/I_ serum ALl" at baseline. On liver biopsy, 10 of the 29 patients (34.48%) with normal ALT had cirrhosis or incomplete cin'hosis. (stage 2.5 to stag 4). In patients with elevated A1.T, the prevalence of cirrhosis/incomplete cirrhosis was seea in 50% of the population. Differences in histologmal injury seen on liver biopsy (p<0.09) and nutritional status (BMI)(p<0.08) sho,a~ed a trend towards significance (p>0.05 < 0.10) AASLD Abstracts A-778

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",,,,ere retrospectively reviewed. Patients with other liver diseases, on immunosuppressive therapy, or had prior trat)splants were exclu&d. Hepatic fibrosis was assessed blindly by one pathologist using the ishak score. Significant fibrosis was defined as Ishak score ->3 and cirrhosis >-5. Clinical and laboratory variables for patients with and without significant fibrosis and cirrhosis were tested by uinvariate and multivariate analysis to construct one model that would predict both significant fibrosis and cirrhosis. Results 205 patients were included in the study, 133(65%)men, mean age 46years. 109(53%) patients had lshak score 0-2, 65(32%) lshak 3-4 and 31(15%) Ishak 5-6. The best model for predicting significant hbrosis included INR, platelets and AST, with an area under ROC curve (AROO of 0.79. \121e best model for predicting cirrhosis included ALT, platelets, AST/ALT ratio, with AROC of 0.92. Progression of fibrosis was associated with rise in AST and drop in platelets. Hence, a novel index (AST Platelet Ratio Index, APRI) was created by dividing AST(xULN) by platelets(k/mm~), and multiplying by 100. AROC of APRl for predicting significant fibrosis and cirrhosis were 0 8 0 and 0.90, respectively (see graph). Using the APRI, a score of -<0.5 ~ld NPV ot 85% tor sigmficant tibrosis, and a score of -<2.0 had NPV of 93% for cirrhosis. Conclusion A single, novel in&x using readily available laboratory data was accurate in excluding both significant fibrosis and cirrhosis in 29% and 85% of the study population, respectively. Application of this index may decrease the need for liver biopsy among CHC patiems.

R O C c u r v e o f A P R I

0 0,2 0.4 0.6 0.8 t

1 - specificAy

T1264

Application of Telemedicine in the Management of Chronic Hepatitis C in Texas Prisons Daryl T.-Y. Lau, Syed Fehmi, Darlene Sit:uentes

Background and Aim: The HCV seroprevalence was estimated to be 29% m the Texas prisons. A standardized HCV treatment algorittml was implemented in }-ear 2000. Since there were over 100 prison units in the state, Telemediciue clinics were utilized for this initiative. An intense HCV education program was provided to die health personnel from the umts prior to the launch of the HCV program. The aim of this study was to summarize our experience applying Telemedicme in managing dmmic HCV in the correctional setting. Methods: The HC%' treatment protocol tbllowed closely to the standard of care in the commmfities. Siilce psychiatric problems were common in this population, patients with history of mental illnesses were evaluated prior to therapy. Those qualified for therapy' and had sentence louger ttran 18 months were asked to sign an informed consent form to ensure their compliance. At screening, tim unit physicians discussed with the hepatologists about the medical conditions arid lafiorato W results of the patients via Telemedicine. The candidates were started on intert~ron-alpha 2a 3MU SC tiw with weight-based nbavirin (1-1.2 g) daily. Treatment duration was dependent on HC_~," genotype: Max. 48 wks for genotype 1 and 24 wks tbr genotype non-l. Throughout the treatment period, regular Tehemedicine cliincs were scheduled between the unit phy'sicians and the specialists to discuss the side effects and laboratory resuhs profiles. Remlts: To date, 470 treatment patients completed at least 6 months of therapy. Among them, there were 52% W~ites (W), 18% African Americans (AM) and 30% Hispanics (Hi. H(N genoty~ 1 was more frequent among A~rican Americans compared to the other two races (AM=95% vs W = 66% vs. H=67%). The overall virological response for genotypel patients at 6 months was 33%. Them were, however, significant ditterencen between the races: W = 4 2 % es. B=22% vs. H=33%. Among the genotype non-1 patients, 71% had end~ofLtreatmem virological respouse. 58 (13%) patients had premature discontinuation of therapy due to side effects (4%), non-compliance (4.5%) and early parole (45%) An additional 28 (6%) had dose reduction due to anemia and neutropenia. Conclusion: Based on this preliminary analysis, HCV can be successfully" man- aged in tim complex prison system ntilizing Telcmedicine. There were comparable rates of respoilse and side effects as in the general communities. Carefi.d patient screening and close monitoring are critically important to ensure compliance and to detect early adverse events m this population.

T1265

Study of Relationship Between Upper Gastrointestinal Bleeding and Hepato Renal Failure in Cirrhosis Ashraf R. Abulfutuh, Mohammed Morsy, Abd E1 Ghany Solyman, Said El Hendav, T, Mohammed El Desouky, Salwa El Hadad, Moemena Kamel

Background:Gastrointestinal bleeding (GIB) has been classically consi&red as a precipitating factor of hepato renal failure in patients with cirrhosis.Aim: This study was aimed at assessing the incidence ,clinical course , predictive factors and prognosis of bepato renal Mlure in patients with cirrhosis and GIB Methods:One-hmadred and seventy-five cortsecutive episodes of GIB in 161 patients with cirrhosis were analyzed .A control group of patients with GIB without cirrhosis matched by age and intensity of the bleeding was analyzed for comparison .Thirty-one clinical and laboratory variables obtained at admission or during hospitalization related with the bleeding episode or with liver and renal function were analyzed as possible predictors of hepato renal failure and in-hospital mortality in patients with cirrhosis .Results: Hepato renal failure occurred in 20 (11%) episo&s in patients with cirrhosis compared to only one (1%) in patients without cirrhosis (p<0.05).In patients v,,ith cirrhosis hepato renal failure fbllowed a progressive course in 10 episodes ,steady" in 5 and transient in 5. In 7 of the 20 episodes.(35%), hepato re)lal failure was associated with ischemic hepatitis. In&pendent predictors of bepato renal failure in patients with cirrhosis were the presence of shock, number of packed red blood cells transfused ,Child Pugh class at admission, and baseline platelet count. Sixteen patients with cirrhosis (9%) died during hospitalization .The develop- ment of bepato renal failure and shock were the only in&pen&nt predictors of mortality,Co> clusion:Hepato renal failure is a relatively- common event in patients with cirrhosis and GIB, the occurrence of which is mainly related to tbe severity of bleeding and baselin liver function. Hepato renal failure is a strong predictor of mortality, better than liver failure in patients with cirrhosis and GIB. The presence of cirrhosis predisposes to the development of hepato renal failure after G1B.

T1266

Escalation of Interferon and Ribavirin for Recurrent Hepatitis C after Liver Transplantation: Increasing Adherence to Therapy Nazir Rahim, Katherine Suggett, Christoph Troppmann, Colette Chambers, John McVicar, Lorenzo Rossaro

Background: Hepatitis C virus (HCV) treatment after liver transplantation (LT) has been difficult. The reported drop out rates range from 22%-50% with combination interleron (INF) and ribavirin (RBV) therapy. Main reasons for discontinuation are bone marrow toxicity and hemolytic anemia. Aim: To use escalating doses of IFN and RBV in COl~}unction with growth factors to prevent dose reduction and enhance adherence. Methods: We prospectivdy analyzed data tu ten patients (90% male, mean age 48 years, 60% genotype 1, primary immunosuppression with tacrolimus and prednisone) with biopsy proven recurrent HCX/" after LT. IFN dosing started at 1 M1U tiw, increased by 0.5 MIU biweekly to a maximum dose of 3 MILl tiw. RBV dosing started at 200 mg bid, increased by 200 mg biweekly to >- 10 mg/kg/day with intention to treat for 48 weeks. Weekly filgrastim (median: 900, range 300-2400 units) and erythropoietin (20-40 x 103 units) doses were utilized once absolute nentrophil count (ANO or hemoglobin (Hgb) levels dropped below 1.0 xlO3/mm 3 or ] l g dl, respectively, with goal to keep ANC above 1.5 x l07mm 3 and Hgb above 10 g/dl. Results: To date, 9 of 10 patients completed 24 weeks of therapy. One patient dropped out of study' prior to 24 weeks of therapy due to hepatic &compensation. All patients achieved -> 80% of target doses at 12 weeks. 70% of patients required filgrasmn or erythropoietin by 8 and 12 weeks, respectively ANC remained stable (baseline: 3.91 -+2.7 12 weeks: 4.2-+3.4; 24 weeks: 3.5_+27 xlO3/mm 3, p=NS) and Hgb dropped (baseline: 149+-2.1; 12 weeks: 126 -+ 1.3; 24 weeks 11.6 -+ 1.5 g/dl, p<O.05), but their levels were maintained above target by" using growth factors with less than 20% reduction in doses of IFN and RBV Three of 9 patients achieved viral clearance at 24 weeks with negatis'e qualitative HCV-RNA. Conclu- sion: Our preliminary data suggest that escalating doses of IFN and RBV and early use 0[ growth tactors allow ->80% adharence to therapy in patients with recurrent HCV alier LT.

T1267

Significant Percentage Of Normal ALT Values seen in Chronic HCV infected patients at a VA Medical Center. Venkat Raugaraj

Often the diagnosis of HCV infection is confirmed after abnormalities are seen m biochemical tests fbr liver injury-, i.e. ALT (alanina aminotransferase). Some have proposed that a uormal ALT indicates minimal or no liver injury. This is diflkult to &tennine in a disease, which is characterized by slow non-linear progression. This study" was undertaken to turther clarify the significance of normal ALT m veterans with active chronic HCV infection. Methods: Eighty sex'en HCW positive outpatients referred for treatment at the VA Medical Center Cincinnati were studied prospectively, lh'e-treatmem laboratory" tests included ALT levds, viral genotypes and HCV-RNA loads were obtained on every patient. Patients with established disease were treated with interferon alpha 2b or Pegylated interteron alpha 2b in combination with Ribavirin using generally accepted protocols Serum HCV-RNA levels were obtained at 0, 3, 6, 12 months alter initiating treaunent and again at 18 months (6 months pnsl treatment). Pre-treatment liver biopsy to stage the fibrosis was performed on every patient Treatment was not initiated on any patient if consumption of alcohol was observed in the preceding 3 month period. We then compared the follov, ing 7 variables (race, age, virolo~" genotype, nntntinn, biopsy result and response to treatment) of each of the two clinical groups, (normal vs elevated ALT levels). Results: From a pool of 87 patients (85 males 2 females), we identified 29 patients (33.33%) with normal serum ALT (<50 IU~) and 58 patients (6667%) with >50 IU/I_ serum ALl" at baseline. On liver biopsy, 10 of the 29 patients (34.48%) with normal ALT had cirrhosis or incomplete cin'hosis. (stage 2.5 to stag 4). In patients with elevated A1.T, the prevalence of cirrhosis/incomplete cirrhosis was seea in 50% of the population. Differences in histologmal injury seen on liver biopsy (p<0.09) and nutritional status (BMI)(p<0.08) sho,a~ed a trend towards significance (p>0.05 < 0.10)

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