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Cost-effective analysis of different strategies of hepatitis a vaccination in adults: A markov model analysis
April 1998 L0130 SUCCESSFUL TREATMENT OF SEVERE THROMBOCYTOPENIA IN A CIRRHOTIC PATIENT WITH PORTAL HYPERTENSION USING PARTIAL SPLENIC ARTERY EMBOLIZATION. W. Dahhan, R.M. Agrawal, A. Thomas, G.J. Brodmerkel. Division of Gastroenterology, Allegheny University of the Health Sciences, Pittsburgh, PA. INTRODUCTION: Patients with cirrhosis and portal hypertension frequently have splenomegaly, thrombocytopenia, anemia and coagulopathy. Splenectomy is an accepted treatment for thrombocytopenia in patients without portal hypertension, however, splenect0my carries a high risk of intraoperative bleeding in those with underlying portal hypertension. Several studies and case reports advocate partial splenic artery embolization for the management of thrombocytopenia due to splenomegaly. CASE: A 69 year old male with Laennec's cirrhosis, portal hypertension (splenomegaly, ascites), presented with severe thrombocytopenia, coagulopathy, anemia, epistaxis, and melena. He was a poor surgical candidate because of comorbidities of insulin dependent diabetes meUitus, chronic renal failure, coronary artery disease, and sip right pneumonectomy for lung cancer 26 years ago. Hg/Hct were 7.6/22.4, platelets: 16,000, PT: 14.2. EGD revealed grade 4 esophageal varices, and portal hypertensive gastropathy. He received 4 units of packed cells. Initially, he underwent a partial splenic artery embolization using polyvinyl alcohol particles. His platelets increased to a range of 26-36,000 one week post embolization, H/H were stable and no additional blood transfusions were needed. Twelve days later a second partial splenic artery embolization was done, which led to a further increase in platelet count to a range of 60-70,000. CT and MRI of the abdomen showed a 50% decrease in spleen size. His H/H at discharge were 9.9/27.9, WBC 4.4 (preadmission was 2.8). CONCLUSION: Partial splenic artery embolization may be a useful procedure for the management of splenomegaly and thrombocytopenia in cirrhotic patients with portal hypertension. It may decrease the frequency of bleeding and blood replacement therapy by increasing platelets count and function. More controlled studies are warranted before considering this procedure as a standard approach for this patient population. [1] Hideya Noguchi. Changes in platelet kinetics after a partial splenic arterial embolization in cirrhotic patients with hypersplenism. Hepatology 1995 Dec;22(6): 1682-1688. [2] Sangro B. Partial splenic embolization for the treatment of hypersplenism in cirrhosis. Hepatology 1993 Aug;18(2):309-314. L0131 INCREASED PREVALENCE OF HGV INFECTION IN A SELECTED COHORT OF HAEMODIALYSIS (HD) PATIENTS NEGATIVE FOR OTHER BLOOD-BORNE VIRUSES. G.N. Dalekos 1, E Zervou 2, D.S. Boumbal, M. Elisaf1, K. Katopodis 3, G.S. Sferopoulos 3, K.C. Siamopoulos 3, EV. Tsianos 1. Dept of Internal Medicine (Divisions of qntemal Medicine and 3Nephrology) Medical School, University of Ioannina and 2Blood Bank at the University Hospital of Ioannina. HGV-RNA detection has already been evaluated in HD patients (0-57%). However, very few data are available on HGV infection in selected cohorts of patients negative for other blood-borne viruses. This study was conducted in an attempt to evaluate the prevalence, risk factors and clinical manifestations of HGV infection in a selected group of HD patients who were negative for HGV, HCV, HIV and HTLV-I/II infections for at least one year befor this study. Sixty four (43 men and 21 women, age range 17-73 years) chronic HD patients were investigated for the presence of HGV-RNA by two available RT-PCRs (Quiagen, Sorin Biomed. Diagn and Acu Gen HGV RT-Amplisensor assay, Biotronics, Tech. Corp). In addition, 285 blood donors (185 men and 100 women, age range 19-65 years) were investigated for HGV-RNA detection. Ten HD patients (15.6%) were positive for HGV-RNA with both of the RT-PCRs, whereas only 2/285 of blood donors (p<0.00005). HGV-RNA detection was associated with significantly lower prevalence of previous markers of HBV infection (p<0.05), lower rate of transfusions (p<0.05) and a lower-although not statistically significant (p<0.10) -mean duration of HD. By contrast, there was not significant differences between HGV-positive andnegative HD patients concerning the rate and the duration of erythropoietin administration, the presence of previous history of increased AST and ALT or the mean AST and ALT values during the three months previous to the study. Conclusions: We demonstrated that a significant proportion (15.6%) of HD patients negative for other blood-borne viruses, tested positive for HGV-RNA. This finding was negatively associated with the known routes of transmission of blood-borne viruses indicating that although HGV can be transmitted by transfusions, acquisition by other means, as already reported for HCV should be kept in mind. This study also showed that the prevalence of HCV does not predict the respective prevalence of HGV. HGV may be an indirect marker for potentially intraunit transmission of viral diseases but its role in liver disease among HD patients remains unclear.
AASLD A1231 • L0132 LIVER ADENOMATOSIS. T. Dao, L. Chiche*, MP. Galais, P. Rousselot**, E. Salame*, P. Segol*. Departments of Hepatogastroenterology, Surgery* and Pathology**, C.H.U. CAEN, FRANCE. Liver adenomatosis (LA) is a rare disease (30 previously reported cases) defined by the presence of multiple adenomas (>10) in an otherwise normal parenchyma. This entity was defined in 1985. Very little data on long term evolution is available. The aim of this study is to describe the features of LA from a series of 9 cases. Method: From 1980 to 1997, we observed 9 patients with LA. Diagnosis was based on imaging findings and miCroscopic examination of a percutaneous (n=l) or surgical biopsy (n=8). Results: Clinical findings are summarized in table 1. No. Sex
l 2 3 4 5 6 7 8 9
F F F F F F F F M
Oral Age Clinical contramanifestations ceptives
Intra tumorous Outcome or intra (follow-up= peritoneal 2-17 years) bleeding No 17 hepatomegaly No W OLT No 45 None No W No 22 abdominalpain Yes W hepatectomy No 22 abdominalpain Yes W OLT 16y 42 abdominalpain Yes W hepatectomy 3y 41 abdominalpain No W No 18 I vomiting No W hepatectomy ly 18 abdominalpain Yes Death No 15 None No W W = well, OLT = orthotopic liver transplantation
Serum ALP and GGT were increased in 3 patients. Serum aFP was normal. Imaging findings were non specific and underestimated the number of nodules. OLT was performed for several episodes of intratumorous bleeding (N°I) or suspicion of malignant tranformation (N°4). 4 patients were members of the same family (N°I, 2, 8, 9). In 1 case (N°5), over 3 years of followup, after stopping oral contraceptive intake, nodules decreased in number and size and disappeared. Conclusion: From these 9 cases and the review of previously reported cases, the main characteristics of LA are: female predominance, high rate of haemorrhagic complications associated with oral contraceptive use. The risk of malignant transformation remains to be evaluated. • L0133 COST-EFFECTIVE ANALYSIS OF DIFFERENT STRATEGIES OF HEPATITIS A VACCINATION IN ADULTS: A MARKOV MODEL ANALYSIS. A Das. Division of Gastroenterology, University Hospitals of Cleveland, Cleveland, Ohio. Introduction: Hepatitis A virus (HAV) causes significant morbidity and mortality in the adult population of developed countries and with the declining prevalence of natural immunity in the general population, the adults in these countries will increasingly become more susceptible to HAV infection and potentially severe disease. Now that a safe and effective vaccine for HAV is available, cost effectiveness of HAV vaccination in the general adult population needs to be evaluated. Methods: Three different strategies of adult vaccination were compared in a hypothetical cohort of 10,000 twenty-year old subjects by constructing a Markov model using DATA 3.0 software (TreeAge softwares, Inc.) and following the cohort through their life time. In strategy I, universal vaccination with an inactivated HAV vaccine (0, 1, 12 month schedule) was pursued; in strategy II, all subjects were initially screened for presence of protective antibody by commercially available immunoassay and if susceptible, they were vaccinated. In the third strategy no vaccination was offered. The outcome measures compared in the three strategies were cost per patient and quality adjusted life years (QALY). Cost estimates, initial and transitional probabilities and other clinical variables were estimated on the basis of available literature. Cost analysis was done with a societal perspective, both direct and indirect costs were considered and future costs were discounted at 5%. Sensitivity analyses were done to evaluate the effect of variations o f the key clinical and cost variables, ranging from a best case to a worst case scenario. Results: In the base case analysis with a seroprevalence of natural immunity at 25%, probability of compliance with vaccination at 80% and protective efficacy of vaccination at 95%, the cost per patient in strategies I, II, III were $109, $92 and & $38 respectively. Strategy II (prescreening and vaccination) dominated the strategy of universal vaccination (strategy I) and the marginal C/E ratio of strategy II over strategy III (no vaccination) was $60,175 per QALY. Except when the excess mortality due to HAV was > 15%, the vaccination strategies (I & II) did not yield any gain in QALYs over strategy III. When the annual prevalence of HAV infection was more than 0.009, of the three strategies, strategy II was the most cost-effective strategy. Coneinsion: Strategies of vaccination of adults against Hepatitis A infection in developed countries may be cost-effective by the standard of current health interventions. Strategy of screening for protective antibody followed by vaccination of susceptible individuals is more cost-effective than a strategy of universal vaccination.
AASLD A1231 • L0132 LIVER ADENOMATOSIS. T. Dao, L. Chiche*, MP. Galais, P. Rousselot**, E. Salame*, P. Segol*. Departments of Hepatogastroenterology, Surgery* and Pathology**, C.H.U. CAEN, FRANCE. Liver adenomatosis (LA) is a rare disease (30 previously reported cases) defined by the presence of multiple adenomas (>10) in an otherwise normal parenchyma. This entity was defined in 1985. Very little data on long term evolution is available. The aim of this study is to describe the features of LA from a series of 9 cases. Method: From 1980 to 1997, we observed 9 patients with LA. Diagnosis was based on imaging findings and miCroscopic examination of a percutaneous (n=l) or surgical biopsy (n=8). Results: Clinical findings are summarized in table 1. No. Sex
l 2 3 4 5 6 7 8 9
F F F F F F F F M
Oral Age Clinical contramanifestations ceptives
Intra tumorous Outcome or intra (follow-up= peritoneal 2-17 years) bleeding No 17 hepatomegaly No W OLT No 45 None No W No 22 abdominalpain Yes W hepatectomy No 22 abdominalpain Yes W OLT 16y 42 abdominalpain Yes W hepatectomy 3y 41 abdominalpain No W No 18 I vomiting No W hepatectomy ly 18 abdominalpain Yes Death No 15 None No W W = well, OLT = orthotopic liver transplantation
Serum ALP and GGT were increased in 3 patients. Serum aFP was normal. Imaging findings were non specific and underestimated the number of nodules. OLT was performed for several episodes of intratumorous bleeding (N°I) or suspicion of malignant tranformation (N°4). 4 patients were members of the same family (N°I, 2, 8, 9). In 1 case (N°5), over 3 years of followup, after stopping oral contraceptive intake, nodules decreased in number and size and disappeared. Conclusion: From these 9 cases and the review of previously reported cases, the main characteristics of LA are: female predominance, high rate of haemorrhagic complications associated with oral contraceptive use. The risk of malignant transformation remains to be evaluated. • L0133 COST-EFFECTIVE ANALYSIS OF DIFFERENT STRATEGIES OF HEPATITIS A VACCINATION IN ADULTS: A MARKOV MODEL ANALYSIS. A Das. Division of Gastroenterology, University Hospitals of Cleveland, Cleveland, Ohio. Introduction: Hepatitis A virus (HAV) causes significant morbidity and mortality in the adult population of developed countries and with the declining prevalence of natural immunity in the general population, the adults in these countries will increasingly become more susceptible to HAV infection and potentially severe disease. Now that a safe and effective vaccine for HAV is available, cost effectiveness of HAV vaccination in the general adult population needs to be evaluated. Methods: Three different strategies of adult vaccination were compared in a hypothetical cohort of 10,000 twenty-year old subjects by constructing a Markov model using DATA 3.0 software (TreeAge softwares, Inc.) and following the cohort through their life time. In strategy I, universal vaccination with an inactivated HAV vaccine (0, 1, 12 month schedule) was pursued; in strategy II, all subjects were initially screened for presence of protective antibody by commercially available immunoassay and if susceptible, they were vaccinated. In the third strategy no vaccination was offered. The outcome measures compared in the three strategies were cost per patient and quality adjusted life years (QALY). Cost estimates, initial and transitional probabilities and other clinical variables were estimated on the basis of available literature. Cost analysis was done with a societal perspective, both direct and indirect costs were considered and future costs were discounted at 5%. Sensitivity analyses were done to evaluate the effect of variations o f the key clinical and cost variables, ranging from a best case to a worst case scenario. Results: In the base case analysis with a seroprevalence of natural immunity at 25%, probability of compliance with vaccination at 80% and protective efficacy of vaccination at 95%, the cost per patient in strategies I, II, III were $109, $92 and & $38 respectively. Strategy II (prescreening and vaccination) dominated the strategy of universal vaccination (strategy I) and the marginal C/E ratio of strategy II over strategy III (no vaccination) was $60,175 per QALY. Except when the excess mortality due to HAV was > 15%, the vaccination strategies (I & II) did not yield any gain in QALYs over strategy III. When the annual prevalence of HAV infection was more than 0.009, of the three strategies, strategy II was the most cost-effective strategy. Coneinsion: Strategies of vaccination of adults against Hepatitis A infection in developed countries may be cost-effective by the standard of current health interventions. Strategy of screening for protective antibody followed by vaccination of susceptible individuals is more cost-effective than a strategy of universal vaccination.