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Recombinant erythropoietin for treatment of peguilated interferon-ribavirin induced anemia
S90
Abstracts
Treated (7) Untreated (2) P-Value
AJG – Vol. 98, No. 9, Suppl., 2003
Average # Days until transplant
Largest tumor (mm)
Average number of tumors
Tumor size post-Rx
482 65 0.03
45.4⫾17.1 24.0⫾11.0 NS
2.0 1.8 NS
28.0⫾19.0 — 0.03
Tumor Average necrosis change at explant in AFP 75% 2.5% 0.0003
-400 ⫹23 NS
Conclusions: Small HCC can be effectively treated using local ablation therapy. The tumor size can be reduced significantly using chemoembolization, alcohol injection, acetic acid injection, or radio-frequency ablation. Tumor ablation significantly prolongs patient survival on the liver transplant list. Tumor necrosis is significantly greater in the treatment group. Serial measurements of AFP do not correlate with tumor size, tumor necrosis, or response to treatment.
262 A META-ANALYSIS OF URSODEOXYCHOLIC ACID FOR THE TREATMENT OF PRIMARY SCLEROSING CHOLANGITIS Steven E. Gruchy, M.D.*, John M. Fardy, M.D. Memorial University of Newfoundland, St. John’s, NF, Canada. Purpose: Primary sclerosing cholangitis (PSC) is a progressive liver disease of unknown etiology. This disease can lead to many potential lethal clinical situations including liver cirrhosis. Ursodeoxycholic acid (UDCA) has been shown to be effective in another cholestatic liver disease, primary biliary cirrhosis. A number of randomized clinical trials using UDCA for the treatment of PSC have been carried out with different results. The main objective of this study was to determine if the literature provides evidence that UDCA is effective at preventing disease progression in patients with PSC. Methods: Meta-analysis was used to evaluate the effect of UDCA on the rate of disease progression in patients with PSC. Only randomized controlled trials that compared UDCA to placebo were included. Three fully published randomized controlled trials as well as one published in abstract form were identified in the literature. A combined end point was used to determine disease progression. This end point consisted of liver biochemistries and liver histology. Results: Pooling of the three fully published randomized controlled trials yielded a standard difference, UDCA compared to placebo, in alkaline phosphatase (ALP) of 18.97 U (95% CI, 8.78, 29.15) favoring UDCA. A standard difference in bilirubin of 15.61 mg/dl (95% CI, 5.200, 26.03) favoring UDCA. Stastitical heterogeneity was not reached when pooling the individual liver biochemistries. An odds ratio of improvement of liver histology in the UDCA group compared to the placebo group was 2.980 (95% CI, 0.823–10.79), which was not significant. Conclusions: These results may indicate that UDCA can improve liver biochemistries; however, whether this improvement in liver biochemistry can be translated into an actual improvement in liver histology and prevention of disease progression can only be determined through further study.
263 MANAGEMENT OF COMPLICATIONS OF CIRRHOSIS IN LIVER TRANSPLANT CANDIDATES Guilherme Macedo, Ph.D.*, Susana Lopes, M.D., Fernando Araujo, M.D., Sonia Barroso, M.D., Jose Costa Maia, M.D., Tavarela Veloso, Ph.D. H.S.Joao, Porto, Portugal. Purpose: Treating complications of cirrhosis became an important issue as it has been recognized that improving biological conditions of liver transplant (OLT) candidates has a significative impact in post OLT morbidity and mortality. Methods: We have evaluated in a 8,5 years period, 240 cirrhotics for transplantation. After identification and exclusion of high risk candidates,
164 patients with Child-Pugh ⱖ8 were selected for elective OLT; all clinical events before OLT were registered. Results: Mean waiting list time was 11 months, and global mortality was 18%. In 60 patients pharmacological primary prophylaxis was begun and in 84, prevention of recurrent bleedind was achieved, along with propranolol, with endoscopic sclerotherapy in acute bleeding (39 patients), elective sclerotherapy (36) and banding (9). In 6 patients hypertonic glucose was injected in bleeding gastric varices and TIPS was used in 5 patients. In 85 patients with ascitis, diuretics were efficient in 50, but in 35 repeated paracentesis was needed and in 3 patients TIPS were effective in controling refractory ascitis. In 24 patients, spontaneous bacterial peritonitis was diagnosed, and all were subsequently enrolled in secondary prophylaxis with quinolone. Only 70 of the 84 bleeding cirrhotic patients were submitted to antibiotics during in-hospital management. Encephalopathy was the main feature in 14 patients (excluding post bleeding or post infection episodes). In 6 hepatocellular carcinoma patients, intention to cure surgery was performed; in 10 patients with hemochromatosis, phlebotomies were begun, and in 10 Wilson’s disease patients, oral chelating agents were given. One HCV cirrhotic patient had a spontaneous liver rupture and had angiographic embolization. Only 20 of 32 HCV cirrhotics were able to had interferon plus ribavirin pre OLT, and lamivudine was begun in 15 HBV infected candidates. Conclusions: We conclude that the inclusion of cirrhotics in a OLT list is a dynamic and evolving process, consuming significative clinical and technical resources, but warrants an improved medical assistance to a particularly high risk group of patients. 264 RECOMBINANT ERYTHROPOIETIN FOR TREATMENT OF PEGUILATED INTERFERON-RIBAVIRIN INDUCED ANEMIA Susana Lopes, M.D., Guilherme Macedo, Ph.D.*, Berta Carvalho, M.D., Tavarela Veloso, Ph.D. H.S.Joao, Porto, Portugal. Purpose: Hemolysis is an universal phenomenon in ribavirin treatment, with interferon, in HCV infected patients. It occurs after the accumulation of ribavirin thriphosphate in red blood cells, which promotes extravascular hemolysis in reticuloendothelial system. Sometimes a significant drop of hemoglobin to less than 10 g/dl, implies dose reduction or withdrawal, because of impaired quality of life and higher risk of cardiovascular morbidity. in oncological studies, it has been suggested that recombinant erythropoietin (RhuEpo) particularly in highly symptomatic patients could achieve to mantain recommended ribavirin dosage for hepatitis C therapy. We present the clinical features of a 28 years old male, transfused in childhood in a right nephrectomy, and recognized to be infected with HCV, genotype 1b (5,98 log) in 2002. Before treatment Hgb was 13,5 g/dl, normal renal function and ALT 152 / AST 102. Histology showed mild necroinflammatory activity with no fibrous septa. At the 4th month of PegINF ⫹ RBV therapy, with adjusted dose to BMI (80 g w PegINF ⫹ 800 mg qd RBV), Hgb dropped to 9,2 g/dl, with normal ALT and negative PCR. He was profoundly asthenic, with orthopneia, and begun 40.000 U/week of RhuEpo, with clinical and biochemical follow up every 2 weeks. At the 8th week of RhuEpo use (6 month PegINF ⫹ RBV treatment), his Hgb was 12,8 g/dl, assymptomatic with normal blood pressure, and reassumed the antiviral treatment schedule as from the beginning. 265 HEPATITIS B VIRUS INFECTION : DEFINITION OF A NEW SUBGROUP OF PATIENTS ELIGIBLE FOR ANTIVIRAL TREATMENT Guilherme Macedo, Ph.D.*, Susana Lopes, M.D., Fernando Araujo, M.D., Fatima Carneiro, Ph.D., Tavarela Veloso, Ph.D. H.S.Joao, Porto, Portugal. Purpose: The group of HBsAg positive patients with permanent or intermittent viral replication inhibition, is highly heterogeneous and includes : coinfected patients (with HCV or HDV), inactive carriers and patients with
Abstracts
Treated (7) Untreated (2) P-Value
AJG – Vol. 98, No. 9, Suppl., 2003
Average # Days until transplant
Largest tumor (mm)
Average number of tumors
Tumor size post-Rx
482 65 0.03
45.4⫾17.1 24.0⫾11.0 NS
2.0 1.8 NS
28.0⫾19.0 — 0.03
Tumor Average necrosis change at explant in AFP 75% 2.5% 0.0003
-400 ⫹23 NS
Conclusions: Small HCC can be effectively treated using local ablation therapy. The tumor size can be reduced significantly using chemoembolization, alcohol injection, acetic acid injection, or radio-frequency ablation. Tumor ablation significantly prolongs patient survival on the liver transplant list. Tumor necrosis is significantly greater in the treatment group. Serial measurements of AFP do not correlate with tumor size, tumor necrosis, or response to treatment.
262 A META-ANALYSIS OF URSODEOXYCHOLIC ACID FOR THE TREATMENT OF PRIMARY SCLEROSING CHOLANGITIS Steven E. Gruchy, M.D.*, John M. Fardy, M.D. Memorial University of Newfoundland, St. John’s, NF, Canada. Purpose: Primary sclerosing cholangitis (PSC) is a progressive liver disease of unknown etiology. This disease can lead to many potential lethal clinical situations including liver cirrhosis. Ursodeoxycholic acid (UDCA) has been shown to be effective in another cholestatic liver disease, primary biliary cirrhosis. A number of randomized clinical trials using UDCA for the treatment of PSC have been carried out with different results. The main objective of this study was to determine if the literature provides evidence that UDCA is effective at preventing disease progression in patients with PSC. Methods: Meta-analysis was used to evaluate the effect of UDCA on the rate of disease progression in patients with PSC. Only randomized controlled trials that compared UDCA to placebo were included. Three fully published randomized controlled trials as well as one published in abstract form were identified in the literature. A combined end point was used to determine disease progression. This end point consisted of liver biochemistries and liver histology. Results: Pooling of the three fully published randomized controlled trials yielded a standard difference, UDCA compared to placebo, in alkaline phosphatase (ALP) of 18.97 U (95% CI, 8.78, 29.15) favoring UDCA. A standard difference in bilirubin of 15.61 mg/dl (95% CI, 5.200, 26.03) favoring UDCA. Stastitical heterogeneity was not reached when pooling the individual liver biochemistries. An odds ratio of improvement of liver histology in the UDCA group compared to the placebo group was 2.980 (95% CI, 0.823–10.79), which was not significant. Conclusions: These results may indicate that UDCA can improve liver biochemistries; however, whether this improvement in liver biochemistry can be translated into an actual improvement in liver histology and prevention of disease progression can only be determined through further study.
263 MANAGEMENT OF COMPLICATIONS OF CIRRHOSIS IN LIVER TRANSPLANT CANDIDATES Guilherme Macedo, Ph.D.*, Susana Lopes, M.D., Fernando Araujo, M.D., Sonia Barroso, M.D., Jose Costa Maia, M.D., Tavarela Veloso, Ph.D. H.S.Joao, Porto, Portugal. Purpose: Treating complications of cirrhosis became an important issue as it has been recognized that improving biological conditions of liver transplant (OLT) candidates has a significative impact in post OLT morbidity and mortality. Methods: We have evaluated in a 8,5 years period, 240 cirrhotics for transplantation. After identification and exclusion of high risk candidates,
164 patients with Child-Pugh ⱖ8 were selected for elective OLT; all clinical events before OLT were registered. Results: Mean waiting list time was 11 months, and global mortality was 18%. In 60 patients pharmacological primary prophylaxis was begun and in 84, prevention of recurrent bleedind was achieved, along with propranolol, with endoscopic sclerotherapy in acute bleeding (39 patients), elective sclerotherapy (36) and banding (9). In 6 patients hypertonic glucose was injected in bleeding gastric varices and TIPS was used in 5 patients. In 85 patients with ascitis, diuretics were efficient in 50, but in 35 repeated paracentesis was needed and in 3 patients TIPS were effective in controling refractory ascitis. In 24 patients, spontaneous bacterial peritonitis was diagnosed, and all were subsequently enrolled in secondary prophylaxis with quinolone. Only 70 of the 84 bleeding cirrhotic patients were submitted to antibiotics during in-hospital management. Encephalopathy was the main feature in 14 patients (excluding post bleeding or post infection episodes). In 6 hepatocellular carcinoma patients, intention to cure surgery was performed; in 10 patients with hemochromatosis, phlebotomies were begun, and in 10 Wilson’s disease patients, oral chelating agents were given. One HCV cirrhotic patient had a spontaneous liver rupture and had angiographic embolization. Only 20 of 32 HCV cirrhotics were able to had interferon plus ribavirin pre OLT, and lamivudine was begun in 15 HBV infected candidates. Conclusions: We conclude that the inclusion of cirrhotics in a OLT list is a dynamic and evolving process, consuming significative clinical and technical resources, but warrants an improved medical assistance to a particularly high risk group of patients. 264 RECOMBINANT ERYTHROPOIETIN FOR TREATMENT OF PEGUILATED INTERFERON-RIBAVIRIN INDUCED ANEMIA Susana Lopes, M.D., Guilherme Macedo, Ph.D.*, Berta Carvalho, M.D., Tavarela Veloso, Ph.D. H.S.Joao, Porto, Portugal. Purpose: Hemolysis is an universal phenomenon in ribavirin treatment, with interferon, in HCV infected patients. It occurs after the accumulation of ribavirin thriphosphate in red blood cells, which promotes extravascular hemolysis in reticuloendothelial system. Sometimes a significant drop of hemoglobin to less than 10 g/dl, implies dose reduction or withdrawal, because of impaired quality of life and higher risk of cardiovascular morbidity. in oncological studies, it has been suggested that recombinant erythropoietin (RhuEpo) particularly in highly symptomatic patients could achieve to mantain recommended ribavirin dosage for hepatitis C therapy. We present the clinical features of a 28 years old male, transfused in childhood in a right nephrectomy, and recognized to be infected with HCV, genotype 1b (5,98 log) in 2002. Before treatment Hgb was 13,5 g/dl, normal renal function and ALT 152 / AST 102. Histology showed mild necroinflammatory activity with no fibrous septa. At the 4th month of PegINF ⫹ RBV therapy, with adjusted dose to BMI (80 g w PegINF ⫹ 800 mg qd RBV), Hgb dropped to 9,2 g/dl, with normal ALT and negative PCR. He was profoundly asthenic, with orthopneia, and begun 40.000 U/week of RhuEpo, with clinical and biochemical follow up every 2 weeks. At the 8th week of RhuEpo use (6 month PegINF ⫹ RBV treatment), his Hgb was 12,8 g/dl, assymptomatic with normal blood pressure, and reassumed the antiviral treatment schedule as from the beginning. 265 HEPATITIS B VIRUS INFECTION : DEFINITION OF A NEW SUBGROUP OF PATIENTS ELIGIBLE FOR ANTIVIRAL TREATMENT Guilherme Macedo, Ph.D.*, Susana Lopes, M.D., Fernando Araujo, M.D., Fatima Carneiro, Ph.D., Tavarela Veloso, Ph.D. H.S.Joao, Porto, Portugal. Purpose: The group of HBsAg positive patients with permanent or intermittent viral replication inhibition, is highly heterogeneous and includes : coinfected patients (with HCV or HDV), inactive carriers and patients with