interferon alfacon-1 (infergen®) 15 mcg in the treatment of naive chronic hepatitis c patients,...

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IVDU use could be ascertained, 81 completed the Beck Depression Inven- tory-II (BDI-II) and Beck Anxiety Inventory (BAI). Results: Patients with no history of IVDU (IVDU2 group; N 5 27) were 59.3% male and had an average age of 48.41 years (SD 5 9.02). Patients with a positive IVDU history (IVDU1 group; N 5 54) were 64.8% male, with an average age of 44.59 years (SD 5 6.28). There were no significant differences in age or gender composition of the two groups. The average BDI-II and BAI scores for the IVDU2 group were 15.41 (SD 5 10.80) and 11.48 (SD 5 10.09), respectively. For the IVDU1 group, average BDI-II and BAI scores were 17.70 (SD 5 12.33) and 14.46 (SD 5 11.74), respectively. There was no significant difference between the IVDU2 and IVDU1 groups in degree of mood impairment on either measure. Both groups reported depressive and anxious symptoms in the mild range. Conclusions: 1) More than 50% of HCV patients reported a history of IVDU. 2) Patients with a history of IVDU did not exhibit more severe depressive and anxious symptomatology than non-IVDU patients. 3) These results suggest that mood impairment associated with HCV is not greater in patients with a history of IVDU. 348 Severity and comorbidity of depression and anxiety in patients with chronic hepatitis C not receiving antiviral therapy Robin C Hilsabeck, William Perry, Tarek I Hassanein*. University of California, San Diego, San Diego, CA, United States. Purpose: Depression and anxiety in patients with hepatitic C (HCV) has been well documented, and antiviral therapy for HCV has been shown to exacerbate both conditions. Since depression and anxiety of significant severity can adversely affect compliance and tolerance to medication, we examined the severity and comorbidity of these disorders in HCV patients not receiving antiviral therapy. Methods: Seventy-seven patients with chronic HCV and 15 normal com- parison subjects completed the Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI). Results: The average BDI-II and BAI scores for patients were 17.10 (SD 5 12.30) and 13.08 (SD 5 11.29), respectively, which are in the mild range of severity. The normal comparison group obtained average scores of 4.47 (SD 5 3.76) and 3.60 (SD 5 2.87) on the BDI-II and BAI, respectively, which are in the normal range. There was a significant difference between patients and the comparison group on both measures. When considering significant symptomatology (i.e., symptoms in the moderate and severe ranges), 24 patients (31.2%) reported both significant depression and anx- iety. Seven patients (9.1%) reported only significant depression and 4 patients (5.2%) reported only significant anxiety. Forty-two patients (54.5%) did not report either depressive or anxious symptoms in the moderate or severe ranges. Conclusions: 1) Severity varies, with approximately 40% of patients reporting symptomatology in the moderate and severe ranges for depres- sion or anxiety. 2) Anxiety was more prevalent than depression in this sample (59.7% vs. 51.6%, respectively). 3) Moderate to severe symptom- atology of both depression and anxiety was more prevalent than either disorder alone. 4) Management of depression and anxiety prior to initiation of antiviral therapy for HCV is recommended and may improve tolerance and compliance. Severity Patients BAI CONTROLS BAI BDI-II BDI-II Minimal 38 (49.3%) 31 (40.3%) 15 (100%) 12 (80%) Mild 8 (10.4%) 18 (23.4%) 0 3 (20%) Moderate 15 (19.5%) 15 (19.5%) 0 0 Severe 16 (20.8%) 13 (16.9%) 0 0 349 Effect of propranolol for the prevention of spontaneous bacterial peritonitis Shinichi Hoshino, M.D., Susumu Shinoura, M.D., Hiroshi Akamine, M.D., Kaoru Kikuchi, M.D., Yoshihide Keida, M.D. Okinawa Chubu Hospital, Okinawa, Japan. Background: Spontaneous Bacterial Peritonitis (SBP) is a serious com- plication of a patient with liver cirrhosis. It is a well established fact that propranolol effectively reduces portal vein pressure in a cirrhotic patient. Recent studies have also shown that portal hypertension has some rela- tionship with the risk of SBP. Although these fact and studies imply an effect of propranolol for the prevention of SBP in a cirrhotic patient, the clinical study confirming the relationship between propranolol and SBP cannot be found so far. Purpose: This study was designed to assess whether propranolol 30 mg per day can effectively prevent the occurrence of SBP in a cirrhotic patient with ascites. Method: We retrospectively reviewed data on patients of cirrhosis with ascites. Results: 139 patients (99 M, 40 F) of cirrhosis with ascites were studied. 55 patients were treated with propranolol for portal hypertension and 80 patients were not treated with propranolol. No statistical difference of sex, age, etiology and Child-Pugh score could be found between these two groups. The occurrence of SBP in patients with propranolol was 5.5% (3/55) and in patients without propranolol was 27.5% (22/80) with statis- tically significant difference (p 5 0.0013). Conclusion: Propranolol effectively reduces the occurrence of SBP in a cirrhotic patient with ascites. 350 Interferon alfacon-1 (Infergen®) 15 mcg in the treatment of naive chronic hepatitis C patients, three vs. five times a week Carl Jones, Ramez Khoury, Rad Agrawal*. Allegheny General Hospital, Pittsburgh, PA, United States. Purpose: Chronic hepatitis C (CHC) patients treated with a-interferon therapy achieve a sustained biochemical response rate of 20 –25%. The sustained virologic response (SR) in patients with genotype I has been reported to range from 5%–10%. The aim of this open label study is to assess if dosing five times per week (53/wk) is more efficacious than dosing three times per week (TIW) with higher dose Interferon alfacon-1 (Infergen®, also known as consensus interferon). Methods: Naı ¨ve patients with biochemical and histological diagnosis of CHC were entered into the study. Patients were randomized to consensus interferon 15 mcg 53/week or 15 mcg TIW for forty-eight weeks, end of treatment responses are presented in the table below. Results: The median pretreatment HCV RNA level was 5.2 million copies/mL (9800 – 48 million) assayed by National Genetics Institute (100 copies/mL). Eighty percent of patients were infected with geno- type 1. 24% of the patients were African Americans. Dose reductions in the 53/wk and TIW arm were 24% (6/25) and 8% (2/25) respectively. Drop outs due to adverse events were 14% (7/50). Week 48 End of Treatment Response HCV RNA Undetectable 15 mcg TIW 44% (7/16) 15 mcg 53/wk 61% (11/18) Conclusions: The data suggest that patients treated with consensus inter- feron 15 mcg 5 times/week have improved virologic clearance over the TIW therapy group. Both groups tolerated the therapy well. 2513 AJG – September, 2000 Abstracts

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Page 1: Interferon alfacon-1 (Infergen®) 15 mcg in the treatment of naive chronic hepatitis C patients, three vs. five times a week

IVDU use could be ascertained, 81 completed the Beck Depression Inven-tory-II (BDI-II) and Beck Anxiety Inventory (BAI).Results:Patients with no history of IVDU (IVDU2 group; N5 27) were59.3% male and had an average age of 48.41 years (SD5 9.02). Patientswith a positive IVDU history (IVDU1 group; N5 54) were 64.8% male,with an average age of 44.59 years (SD5 6.28). There were no significantdifferences in age or gender composition of the two groups. The averageBDI-II and BAI scores for the IVDU2 group were 15.41 (SD5 10.80) and11.48 (SD5 10.09), respectively. For the IVDU1 group, average BDI-IIand BAI scores were 17.70 (SD5 12.33) and 14.46 (SD5 11.74),respectively. There was no significant difference between the IVDU2 andIVDU1 groups in degree of mood impairment on either measure. Bothgroups reported depressive and anxious symptoms in the mild range.Conclusions: 1) More than 50% of HCV patients reported a history ofIVDU. 2) Patients with a history of IVDU did not exhibit more severedepressive and anxious symptomatology than non-IVDU patients. 3) Theseresults suggest that mood impairment associated with HCV is not greaterin patients with a history of IVDU.

348

Severity and comorbidity of depression and anxiety in patients withchronic hepatitis C not receiving antiviral therapyRobin C Hilsabeck, William Perry, Tarek I Hassanein*. University ofCalifornia, San Diego, San Diego, CA, United States.

Purpose: Depression and anxiety in patients with hepatitic C (HCV) hasbeen well documented, and antiviral therapy for HCV has been shown toexacerbate both conditions. Since depression and anxiety of significantseverity can adversely affect compliance and tolerance to medication, weexamined the severity and comorbidity of these disorders in HCV patientsnot receiving antiviral therapy.Methods: Seventy-seven patients with chronic HCV and 15 normal com-parison subjects completed the Beck Depression Inventory-II (BDI-II) andBeck Anxiety Inventory (BAI).Results:The average BDI-II and BAI scores for patients were 17.10 (SD512.30) and 13.08 (SD5 11.29), respectively, which are in the mild rangeof severity. The normal comparison group obtained average scores of 4.47(SD 5 3.76) and 3.60 (SD5 2.87) on the BDI-II and BAI, respectively,which are in the normal range. There was a significant difference betweenpatients and the comparison group on both measures. When consideringsignificant symptomatology (i.e., symptoms in the moderate and severeranges), 24 patients (31.2%) reported both significant depression and anx-iety. Seven patients (9.1%) reported only significant depression and 4patients (5.2%) reported only significant anxiety. Forty-two patients(54.5%) did not report either depressive or anxious symptoms in themoderate or severe ranges.Conclusions: 1) Severity varies, with approximately 40% of patientsreporting symptomatology in the moderate and severe ranges for depres-sion or anxiety. 2) Anxiety was more prevalent than depression in thissample (59.7% vs. 51.6%, respectively). 3) Moderate to severe symptom-atology of both depression and anxiety was more prevalent than eitherdisorder alone. 4) Management of depression and anxiety prior to initiationof antiviral therapy for HCV is recommended and may improve toleranceand compliance.

Severity

Patients

BAI

CONTROLS

BAIBDI-II BDI-II

Minimal 38 (49.3%) 31 (40.3%) 15 (100%) 12 (80%)Mild 8 (10.4%) 18 (23.4%) 0 3 (20%)Moderate 15 (19.5%) 15 (19.5%) 0 0Severe 16 (20.8%) 13 (16.9%) 0 0

349

Effect of propranolol for the prevention of spontaneous bacterialperitonitisShinichi Hoshino, M.D., Susumu Shinoura, M.D., Hiroshi Akamine,M.D., Kaoru Kikuchi, M.D., Yoshihide Keida, M.D. Okinawa ChubuHospital, Okinawa, Japan.

Background: Spontaneous Bacterial Peritonitis (SBP) is a serious com-plication of a patient with liver cirrhosis. It is a well established fact thatpropranolol effectively reduces portal vein pressure in a cirrhotic patient.Recent studies have also shown that portal hypertension has some rela-tionship with the risk of SBP. Although these fact and studies imply aneffect of propranolol for the prevention of SBP in a cirrhotic patient, theclinical study confirming the relationship between propranolol and SBPcannot be found so far.Purpose:This study was designed to assess whether propranolol 30 mg perday can effectively prevent the occurrence of SBP in a cirrhotic patient withascites.Method: We retrospectively reviewed data on patients of cirrhosis withascites.Results: 139 patients (99 M, 40 F) of cirrhosis with ascites were studied.55 patients were treated with propranolol for portal hypertension and 80patients were not treated with propranolol. No statistical difference of sex,age, etiology and Child-Pugh score could be found between these twogroups. The occurrence of SBP in patients with propranolol was 5.5%(3/55) and in patients without propranolol was 27.5% (22/80) with statis-tically significant difference (p5 0.0013).Conclusion: Propranolol effectively reduces the occurrence of SBP in acirrhotic patient with ascites.

350

Interferon alfacon-1 (Infergen®) 15 mcg in the treatment of naivechronic hepatitis C patients, three vs. five times a weekCarl Jones, Ramez Khoury, Rad Agrawal*. Allegheny GeneralHospital, Pittsburgh, PA, United States.

Purpose: Chronic hepatitis C (CHC) patients treated witha-interferontherapy achieve a sustained biochemical response rate of 20–25%. Thesustained virologic response (SR) in patients with genotype I has beenreported to range from 5%–10%. The aim of this open label study is toassess if dosing five times per week (53/wk) is more efficacious thandosing three times per week (TIW) with higher dose Interferon alfacon-1(Infergen®, also known as consensus interferon).Methods: Naı̈ve patients with biochemical and histological diagnosis ofCHC were entered into the study. Patients were randomized to consensusinterferon 15 mcg 53/week or 15 mcg TIW for forty-eight weeks, end oftreatment responses are presented in the table below.Results: The median pretreatment HCV RNA level was 5.2 millioncopies/mL (9800 – 48 million) assayed by National Genetics Institute(100 copies/mL). Eighty percent of patients were infected with geno-type 1.

24% of the patients were African Americans. Dose reductions in the53/wk and TIW arm were 24% (6/25) and 8% (2/25) respectively. Dropouts due to adverse events were 14% (7/50). Week 48 End of TreatmentResponse

HCV RNA Undetectable

15 mcg TIW 44% (7/16)15 mcg 53/wk 61% (11/18)

Conclusions:The data suggest that patients treated with consensus inter-feron 15 mcg 5 times/week have improved virologic clearance over theTIW therapy group. Both groups tolerated the therapy well.

2513AJG – September, 2000 Abstracts