315

THE ROLE OF RECOMBINANT HUMAN ERYTHROPOIETIN(EPOETIN ALFA) IN THE MANAGEMENT OF RIBAVIRIN(RBV)–INDUCED ANEMIAAijaz Ahmed, M.D., Mindie Nguyen, M.D., Rajesh N. Keswani, M.D.,Judy Grossi, R.N. and Emmet B. Keeffe, M.D.*. Division ofGastroenterology and Hepatology, Stanford University School ofMedicine, Stanford, CA.

Purpose: Interferon (IFN) plus RBV therapy for chronic hepatitis C (CHC)can precipitate severe anemia. Retrospective analysis have shown thatmaintenance of RBV weight–based dose (WBD) at or above 80% improvesvirological response (VR). WBD of RBV (greater than 10.6 mg/kg) resultsin significantly higher incidence of hemoglobin (Hb) decline as comparedto non–WBD of RBV. We report a retrospective analysis comparing theefficacy of epoetin alfa versus RBV dose reduction in the manangement ofRBV–induced anemia in CHC patients (pts) who were treated with IFN/RBV.Methods: 39 pts with CHC who underwent IFN/RBV therapy at a com-munity clinic between 06/01/01–05/31/02 were studied. Pts with new–onset anemia (Hb less than 11 g/dl; Hb drop greater than 3 g/dl frombaseline; or a Hb drop plus exercise intolerance) were included. Pts wereeither managed by epoetin alfa (40,000 units/week sc) or RBV dosereduction. Pts who did not meet the criteria for anemia were excluded.End–of–treatment response (ETR) was compared between the epoetin–treated gp without RBV dose reduction and the untreated gp with RBVdose reduction using Chi–square statistics. ETR was adjusted for genotype(1 versus non–1) by logistic regression.Results: 18/39 (46%) pts were excluded. RBV–induced anemia was treatedwith epoetin alfa in 8/21 (38%) pts and with RBV dose reduction in 13/21(62%) pts. Virological ETR was statistically significant (SS) among theepoetin alfa–treated gp as compared to the untreated gp with RBV dosereduction (75% versus 23%, p�0.02). Anemic pts who received epoetinalfa were able to maintain WBD of RBV. Pts who underwent RBV dosereduction were unable to maintain WBD of RBV. 22% of the epoietinalfa–treated gp had genotype 1 while 77% of the untreated gp had genotype1 (p�0.011). On multivariate analysis, genotype 1 is a strong predictor forlack of ETR (OR�32, p�0.01). RBV dose reduction is associated with anodds ratio of 2.2 for lack of ETR but this was not SS (p�0.57,95%CI�0.14 – 33.0).Conclusions: The wide confidence intervals of the odds ratio of RBV dosereduction reflects our small sample size. Large prospective randomizedstudy is needed to confirm or exclude the beneficial effect of epoetin alfaon VR of IFN/RBV.

316

IS WEEKLY PEG IFN ALPHA 2B WITH RIBAVIRIN THERAPYBETTER THAN DAILY IFN ALPHA 2B WITH RIBAVIRINTHERAPY?Urooj Ahmed, M.D., Shaista Ahmed, M.D., Harlan Wright, M.D.,FACG,Bakr Nour, M.D.,FACG, Ahmet Gurakar, M.D.,FACG and RobertSchade, M.D.,FACG*. Nazih Zuhdi Transplantation Institute, OklahomaCity, OK; Gastroenterology/Hepatology, Medical College of Georgia,Augusta, GA and Gastroenterology, VA Medical Center, Augusta, GA.

Purpose: Comparison of weekly PEG IFN Alpha 2B with daily ribavirinand daily 3 MU of IFN Alpha 2B with ribavirin therapy has not been done.PEG IFN Alpha 2B formulation was created to maintain inteferon bloodlevels and avoid the peaks and troughs observed with 3 MU of Alpha IFN2B three times a week therapy. We performed a retrospective study tocompare results of daily IFN Alpha 2B 3MU with ribavirin and PEG IFNAlpha 2B with ribavirin on viral clearance after 3 months of treatment.Methods: Early viral response (HCV clearance after 3 months of therapy)and need for dose reduction in 34 non–cirrhotic Hepatitis C patients (18females, 16 males) who had been treated with PEG IFN Alpha 2B plusdaily Ribavirin between 06/01 and 04/02 were compared to a group of 25

non–cirrhotic patients (12 females, 13 males) who were treated with daily3 MU IFN Alpha 2B plus ribavirin protocol in 1999.(1) Baseline HCV–RNA levels were determined prior to initiation and after 12 weeks oftreatment (EVR) in each.Results: The mean age of the PEG group was 45 and the mean age of dailyIFN group was 44 yrs. In the PEG group, 15/34 patients (44%) needed dosereduction due to side effects from the treatment. Four of these patientseventually dropped out of treatment, 30 patients remaining on treatmentwere evaluated at the end of the 12th week. 14/30 (47%) became HCV–RNA negative and 16 (53%) remained positive. In the daily Interferongroup 12/25 (43%) needed dose reduction due to side effects. Four patientswere removed due to non–compliance. 12/21 remaining patients (57%)became serum HCV–RNA negative and nine patients (43%) remainedpositive at the end of 12 weeks of treatment.Conclusions: The results between PEG and daily IFN groups were com-parable and no statistically significant differences were observed (P:NS) insuccess, failure or tolerability between these groups. Hence daily IFNAlpha 2b and Ribavirin therapy may be considered as a suitable alternativetreatment option for selected patients. (1) J.OK.St.Med.1999;92(812)573–577.

317

TREATMENT COSTS OF CHRONIC HEPATITIS B ANDRESULTING MEDICAL CONDITIONS IN CANADAYves M. Gagnon, M.Sc., Adrian R. Levy, Ph.D.*, Uchenna H. Iloeje,M.D. and Andrew H. Briggs, D.Phil. Occam Research & ConsultingInc, Vancouver, British Columbia, Canada; University of BritishColumbia, Vancouver, British Columbia, Canada; Bristol–Myers SquibbCompany, Wallingford, CT and University of Oxford, Oxford, UnitedKingdom.

Purpose: Chronic infection with the hepatitis B virus (HBV) leads to aprogressive deterioration of health and increasingly severe medical condi-tions that often result in death. While the natural history is well known,little is known about the costs of treating infected persons. Our goal was todetermine the patterns of resource use and costs in Canada of managinghepatitis B and resulting medical conditions.Methods: Resource utilization and cost data were extracted from: aninterviewer–administered questionnaire completed by eight clinical ex-perts, the Canadian Institute for Health Information hospital dischargedatabase, a large Canadian teaching hospital, and a liver transplant and acancer treatment program. The questionnaire was designed to gather in-formation on frequencies, proportion of patients and health resource quan-tities for six health states. Health resources included diagnostic tests,procedures, hospital stays, outpatient visits, medications and home care.Unit costs were derived from a Canadian list of provincial costs, provincialphysician payment schedules, hospital pharmacies and provincial drugformularies. Average annual treatment costs per patient were calculated foreach health state. A probabilistic analysis incorporating Monte Carlo sim-ulations was conducted to examine the influence of uncertainty in baselinevalues and to estimate 95% confidence intervals (CI) around all mean costs.All costs were reported in 2001 Canadian dollars.Results: The expected annual treatment costs, in increasing order, were:$2,435 (CI: $1,927; $2,977) for chronic hepatitis B, $2,912 (CI: $2,120;$3,836) for compensated cirrhosis, $16,900 (CI: $7,791; $28,410) fordecompensated cirrhosis, $19,092 (CI: $11,636; $29,311) for hepatocellu-lar carcinoma, $41,375 (CI: $30,369; $56,659) for transplant care after thefirst year, and $97,758 (CI: $87,084; $110,869) for liver transplantation.Main cost drivers were medication use and inpatient hospital stays.Conclusions: The financial costs from treating patients with HBV relatedconditions remain substantial. Any new therapy that is able to modifydisease progression and reduce the incidence of the advanced complica-tions of HBV infection should be cost–effective or could even be costsaving.

S104 Abstracts AJG – Vol. 97, No. 9, Suppl., 2002