Transjugular liver biopsy: an analysis of 650 procedures
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patient who was intolerant to treatment has developed a sustained response to HCVRNA eradication. Conclusions: Interferon alpha 2b and Ribavirin were poorly tolerated in this series of patients with only 50% completing treatment and 13% achieving a sustained response to HCV eradication. Pegylated–interferon and ribavirin should be considered for treating recurrent HCV. 288 HOW LONG SHOULD WE TREAT PRIOR NON–RESPONDERS FOR? AN INTERIM ANALYSIS OF THE “FRONTIER TRIAL” Marcelo Kugelmas, M.D.* and Lisa M. Forman, M.D. Medicine, University of Colorado, Health Sciences Center, Denver, CO. Purpose: Treatment with Pegylated interferon and ribavirin may be an option for patients with chronic hepatitis C who have failed Rebetron combination therapy and/or interferon monotherapy. Our aim is to treat previously non–responders patients with chronic hepatitis C with Peg– Intron and ribavirin for 24, 36, or 48 weeks, and assess safety, sustained viral and histologic response rates. Methods: Two hundred patients with compensated liver function have been accrued so far. All receive Peg –Intron 1.5 mcg/kg/weekly and ribavirin 800 mg/d. This is an interim report of early virologic response (EVR) and end of treatment viral response (ETR) in the first 100 patients. Complete data for sustained virologic responses will be presented at the meeting. Results: Twenty–three patients had a negative qualitative HCV–RNA PCR at the end of the first 12 weeks on therapy (EVR23%). Different lengths of treatment had no association with ETR (p0.837) as eight of thirty–two patients treated for 24 weeks achieved an ETR (25%), eight of thirty–three treated for 36 weeks had an ETR (24.2%), and eight of thirty–five treated for 48 weeks had an ETR (22.9%). Table 1 depicts the analysis of ETR according to prior treatment and genotype. No association was found in between gender, age, or race and ETR to Peg–Intron and ribavirin therapy. Six serious adverse events were recorded in this cohort: suicidal ideation W2, pancreatitis W3, gastritis with hematemesis W6, APAP OD W11, and 2 episodes of chest pain at W6 and 20. Table 1: ETR according to genotype and prior treatment in 100 patients treated with Peg–Intron and Ribavirin for different lengths of time Rebetron Interferon Genotype 1 Genotype not–1 24W 5/27* 3/5 6/27 2/5 36W 4/26 4/7 6/30 2/3 48W 4/29 4/6 6/31 2/4 p value 0.001 0.033 * HCV RNA Neg./Total treated Conclusions: The combination of Peg–Intron and ribavirin seems to offer benefit for patients who previously failed interferon– based therapies. These preliminary data also raise the possibility that 24 weeks of therapy rather than 36 or 48 weeks may suffice for these patients. Prior failure to interferon monotherapy and HCV genotype not–1 seem to be associated with a better chance of ETR. Grant support: NIH M01 RR00051 and Schering–Plough. 289 TRANSJUGULAR LIVER BIOPSY: AN ANALYSIS OF 650 PROCEDURES Guilherme Macedo, M.D.,FACG*, Susana Lopes, M.D., Fatima Carneiro, M.D.,Ph.D. and Fernando Tavarela Veloso, M.D, Ph.D., FACG. Gastroenterology Unit, H.S.Joa ˜o, Porto, Portugal. Purpose: There is a substantial risk of bleeding in percutaneous liver biopsies performed in acute liver disease patients or in chronic liver diseases associated with blood dyscrasia or coagulopathy. Also in large volume ascites, percutaneous route may also be contraindicated. In liver transplant centers, the availability of the transjugular (TLB) procedure allows a support for precise diagnosis and for supplementary decisions, either in elucidating cirrhosis etiology or in having liver tissue sample in acute liver failure situations. Methods: We analysed the cumulative experience in 8 years with this procedure. In 370 TLB, we used TJ Henriksen needle, which allows tissue sampling by aspiration. In 280 procedures we used the modified TJ TruCut needle, with a variation of the initial described technique. We describe the dominant indications and observed diagnosis. Results: In 110 patients, TLB was performed in acute liver disease setting. The diagnostic efficacy was 99% with TruCut needle and 70% with aspiration needle. Complications were: carotid puncture in 4% (25 patients) and extracap- sular puncture with aspiration of ascitic fluid in 0,5% (3 patients). Both complications were uneventful. The procedures were temporarily sus- pended in 4 patients because of arrythmia or dorsolombar pain. Because several difficulties in right internal jugular vein access, TLB was performed in 8 patients through the left vein. Conclusions: We conclude that this is an extremely useful and safe technique in hospitals with highly prevalent liver disease, particularly if envolved in every step of staging and treatment of acute or end stage chronic liver disease patients. 290 PEGYLATED–INTERFERON FOR RECURRENT HEPATITIS C IN LIVER TRANSPLANT RECIPIENTS WITH RENAL FAILURE Sandeep Mukherjee, M.D., Richard K. Gilroy, M.D., Timothy M. McCashland, M.D., Daniel F. Schafer, M.D., Rowen K. Zetterman, M.D.,FACG and Michael F. Sorrell, M.D.,FACG*. Department of Medicine, Section of Gastroenterology and Hepatology, University of Nebraska Medical Center, Omaha, NE. Purpose: Recurrent hepatitis C (HCV) is universal following liver trans- plantation (OLT) and is an important cause of retransplantation. It is treated with interferon and ribavirin and more recently pegylated–interferon with ribavirin has been used. We describe our experience with pegylated– interferon monotherapy in a small series of patients in whom ribavirin was contra–indicated due to the presence of renal failure Methods: Between June 2001 and the present, patients diagnosed with recurrent HCV were screened to determine if they were eligible for treat- ment. Recurrent HCV was defined as the presence of HCV viremia (HCVRNA) with a liver biopsy demonstrating recurrent hepatitis, steatosis or non–specific changes. This cohort of patients was followed prospec- tively after starting a treatment protocol of Pegylated–Interferon alpha 2b 1.0 mcg/kg qweekly (Schering–Plough, Kenilworth, New Jersey). All patients were treated for 1 year irrespective of genotype and doses adjusted per treatment protocol. Steroids were discontinued in all patients prior to treatment. Complete blood counts were performed weekly for the first month and monthly thereafter with liver function tests. HCVRNA and liver biopsies were performed prior to treatment, end of treatment (EOT) and 6 months after EOT for those who were HCVRNA negative at EOT. HCVRNA was also checked 3 months into treatment. Results: 39 patients with recurrent HCV were screened. 8 were eligible for treatment with Pegylated –Interferon monotherapy as they had a serum creatinine 1.8 mg/dl. 4 of these patients had also failed Interferon alpha and ribavirin previously. There were 7 males and 1 females with an average age of 55 years. All patients were genotype 1. 7 patients were intolerant to treatment requiring Peg–interferon discontinuation within the first 3 months.1 patient has completed 4 months of treatment and was HCVRNA negative at 3 months.Interestingly, 2 of the 7 intolerant patients have undetectable HCVRNA more than 6 months after Peg–interferon discon- tinuation. Conclusions: Pegylated –Interferon alpha 2b is poorly tolerated in liver transplant recipients with recurrent HCV and chronic renal failure. Larger studies and long–term follow up of this group of patients will be required to determine the effectiveness of this therapy. S95 AJG – September, Suppl., 2002 Abstracts
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Transcript of Transjugular liver biopsy: an analysis of 650 procedures
patient who was intolerant to treatment has developed a sustained responseto HCVRNA eradication.Conclusions: Interferon alpha 2b and Ribavirin were poorly tolerated inthis series of patients with only 50% completing treatment and 13%achieving a sustained response to HCV eradication. Pegylated–interferonand ribavirin should be considered for treating recurrent HCV.
288
HOW LONG SHOULD WE TREAT PRIOR NON–RESPONDERSFOR? AN INTERIM ANALYSIS OF THE “FRONTIER TRIAL”Marcelo Kugelmas, M.D.* and Lisa M. Forman, M.D. Medicine,University of Colorado, Health Sciences Center, Denver, CO.
Purpose: Treatment with Pegylated interferon and ribavirin may be anoption for patients with chronic hepatitis C who have failed Rebetroncombination therapy and/or interferon monotherapy. Our aim is to treatpreviously non–responders patients with chronic hepatitis C with Peg–Intron and ribavirin for 24, 36, or 48 weeks, and assess safety, sustainedviral and histologic response rates.Methods: Two hundred patients with compensated liver function have beenaccrued so far. All receive Peg –Intron 1.5 mcg/kg/weekly and ribavirin 800mg/d. This is an interim report of early virologic response (EVR) and end oftreatment viral response (ETR) in the first 100 patients. Complete data forsustained virologic responses will be presented at the meeting.Results: Twenty–three patients had a negative qualitative HCV–RNA PCRat the end of the first 12 weeks on therapy (EVR�23%). Different lengthsof treatment had no association with ETR (p�0.837) as eight of thirty–twopatients treated for 24 weeks achieved an ETR (25%), eight of thirty–threetreated for 36 weeks had an ETR (24.2%), and eight of thirty–five treatedfor 48 weeks had an ETR (22.9%). Table 1 depicts the analysis of ETRaccording to prior treatment and genotype. No association was found inbetween gender, age, or race and ETR to Peg–Intron and ribavirin therapy.Six serious adverse events were recorded in this cohort: suicidal ideationW2, pancreatitis W3, gastritis with hematemesis W6, APAP OD W11, and2 episodes of chest pain at W6 and 20.
Table 1: ETR according to genotype and prior treatment in 100 patients treatedwith Peg–Intron and Ribavirin for different lengths of time
Rebetron Interferon Genotype 1 Genotype not–1
24W 5/27* 3/5 6/27 2/536W 4/26 4/7 6/30 2/348W 4/29 4/6 6/31 2/4p value �0.001 0.033
* HCV RNA Neg./Total treated
Conclusions: The combination of Peg–Intron and ribavirin seems to offerbenefit for patients who previously failed interferon–based therapies. Thesepreliminary data also raise the possibility that 24 weeks of therapy ratherthan 36 or 48 weeks may suffice for these patients. Prior failure tointerferon monotherapy and HCV genotype not–1 seem to be associatedwith a better chance of ETR.
Grant support: NIH M01 RR00051 and Schering–Plough.
289
TRANSJUGULAR LIVER BIOPSY: AN ANALYSIS OF 650PROCEDURESGuilherme Macedo, M.D.,FACG*, Susana Lopes, M.D., FatimaCarneiro, M.D.,Ph.D. and Fernando Tavarela Veloso, M.D, Ph.D.,FACG. Gastroenterology Unit, H.S.Joao, Porto, Portugal.
Purpose: There is a substantial risk of bleeding in percutaneous liverbiopsies performed in acute liver disease patients or in chronic liverdiseases associated with blood dyscrasia or coagulopathy. Also in largevolume ascites, percutaneous route may also be contraindicated. In livertransplant centers, the availability of the transjugular (TLB) procedure
allows a support for precise diagnosis and for supplementary decisions,either in elucidating cirrhosis etiology or in having liver tissue sample inacute liver failure situations.Methods: We analysed the cumulative experience in 8 years with thisprocedure. In 370 TLB, we used TJ Henriksen needle, which allows tissuesampling by aspiration. In 280 procedures we used the modified TJ TruCutneedle, with a variation of the initial described technique. We describe thedominant indications and observed diagnosis.Results: In 110 patients, TLB was performed in acute liver disease setting.The diagnostic efficacy was 99% with TruCut needle and 70% withaspiration needle.
Complications were: carotid puncture in 4% (25 patients) and extracap-sular puncture with aspiration of ascitic fluid in 0,5% (3 patients). Bothcomplications were uneventful. The procedures were temporarily sus-pended in 4 patients because of arrythmia or dorsolombar pain. Becauseseveral difficulties in right internal jugular vein access, TLB was performedin 8 patients through the left vein.Conclusions: We conclude that this is an extremely useful and safetechnique in hospitals with highly prevalent liver disease, particularly ifenvolved in every step of staging and treatment of acute or end stagechronic liver disease patients.
290
PEGYLATED–INTERFERON FOR RECURRENT HEPATITIS CIN LIVER TRANSPLANT RECIPIENTS WITH RENAL FAILURESandeep Mukherjee, M.D., Richard K. Gilroy, M.D., Timothy M.McCashland, M.D., Daniel F. Schafer, M.D., Rowen K. Zetterman,M.D.,FACG and Michael F. Sorrell, M.D.,FACG*. Department ofMedicine, Section of Gastroenterology and Hepatology, University ofNebraska Medical Center, Omaha, NE.
Purpose: Recurrent hepatitis C (HCV) is universal following liver trans-plantation (OLT) and is an important cause of retransplantation. It is treatedwith interferon and ribavirin and more recently pegylated–interferon withribavirin has been used. We describe our experience with pegylated–interferon monotherapy in a small series of patients in whom ribavirin wascontra–indicated due to the presence of renal failureMethods: Between June 2001 and the present, patients diagnosed withrecurrent HCV were screened to determine if they were eligible for treat-ment. Recurrent HCV was defined as the presence of HCV viremia(HCVRNA) with a liver biopsy demonstrating recurrent hepatitis, steatosisor non–specific changes. This cohort of patients was followed prospec-tively after starting a treatment protocol of Pegylated–Interferon alpha 2b1.0 mcg/kg qweekly (Schering–Plough, Kenilworth, New Jersey). Allpatients were treated for 1 year irrespective of genotype and doses adjustedper treatment protocol. Steroids were discontinued in all patients prior totreatment. Complete blood counts were performed weekly for the firstmonth and monthly thereafter with liver function tests. HCVRNA and liverbiopsies were performed prior to treatment, end of treatment (EOT) and 6months after EOT for those who were HCVRNA negative at EOT.HCVRNA was also checked 3 months into treatment.Results: 39 patients with recurrent HCV were screened. 8 were eligible fortreatment with Pegylated –Interferon monotherapy as they had a serumcreatinine � 1.8 mg/dl. 4 of these patients had also failed Interferon alphaand ribavirin previously. There were 7 males and 1 females with an averageage of 55 years. All patients were genotype 1. 7 patients were intolerant totreatment requiring Peg–interferon discontinuation within the first 3months.1 patient has completed 4 months of treatment and was HCVRNAnegative at 3 months.Interestingly, 2 of the 7 intolerant patients haveundetectable HCVRNA more than 6 months after Peg–interferon discon-tinuation.Conclusions: Pegylated –Interferon alpha 2b is poorly tolerated in livertransplant recipients with recurrent HCV and chronic renal failure. Largerstudies and long–term follow up of this group of patients will be requiredto determine the effectiveness of this therapy.
S95AJG – September, Suppl., 2002 Abstracts
