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Hepatitis B vaccined children at five years of age in need of a booster dose
686A
AASLD ABSTRACTS
HEPATOLOGY October 2001
2055
2056
HEPATITIS B VACCINED CHILDREN AT FIVE YEARS OF AGE IN NEED OF A BOOSTER DOSE. Mohamed A E1 Guindi, Liver Institute, Cairo Egypt; Aleef A Alam, Ahmed A Raouf, Liver Institute, Shebin E1 Kom Egypt
COST-EFFECTIVENESS OF INTERFERON ALFA-2B COMBINED W I T H RIBAVIRIN AS INITIAL TREATMENT OF CHRONIC HEPATITIS C IN THE GERMAN HEALTH CARE SYSTEM. Uwe Siebert, Gaby Sroczynski, Harvard Sch of Public Health, Boston, MA;J(irgen Wasem, Univ of Greifswald, Greifswald Germany; Ulrike Ravens-Sieberer, Robert Koch Inst, Berlin Germany; Wolfgang Greiner, Univ of Hanover, Hanover Germany; B~rbel M Bellach, Robert Koch Inst, Berlin Germany; Pamela Aidelsburger, Univ of Greifswald, Greifswald Germany; Michael Corzillius, Univ of Kiel, Kiel Germany; Monika Bullinger, Univ of Hamburg, Hamburg Germany; J-Matthias Graf von der Schulenburg, Univ of Hanover, Hanover Germany; John B Wong, Tufts Univ Sch of Medicine, Boston, MA; Siegbert Rossol, Univ Hosp of Mannheim, Germany, on behalf of the German Hepatitis C Model (GEHMO) Grp
Objective: Viral hepatitis is a major cause of morbidity and mortality. Hepatitis B and C account for more than 75 percent of the causes for all chronic hepatitis. Hepatitis B vaccination has been implemented in the Egyptian Extended Program for Immunization since 1995. The aim of this work is to study the efficacy of this program and the need for further immunization schedule. Methods: Three hundred neonates immediately after birth were included in the study. Half of them were given 0.5 ml of Engerix-B vaccine and the rest received 0.25 ml of the vaccine at birth, at one month and at six months of age. All proved to be immune against Hepatitis B. After 5 years these children were subjected to clinical evaluation and several investigations including HBsAg, FIBs antibody, HBcAg, HBeAg, anti-HAV, anti-HCV, PCR's, schistosomiasis, mothers profile and others. Results: Two hundred and eighty five child (90.5%) showed negative HBs antibodies while the other 30 children showed positive HBs antibodies at 5 years. Eighty seven of the non-immunized children were given 0.5 ml of the same vaccine to detect their immune response. Originally 30 of these children received 0.25 ml vaccine at birth and the other 57 children received 0.5 ml vaccine at birth. After 45 days from this booster dose, anti-s was repeated. The results revealed that 44 children were converted to positive anti-s and the other 43 remained ant-s negative or non-immunized. The level of antibodies varied greatly in the converted group. Also, a higher number of this converted group was given originally 0.25ml of the vaccine at birth and later on at 1 and 6 months. Therefore, 90% of the vaccinated children showed nondetectable levels of anti-s after 5 years, and 50% of them are in need of more than one dose. Conclusion: There is no difference between 0.25 and 0.5 ml vaccine dose for hepatitis B. All children should receive at least a booster dose of the hepatitis B vaccine at 5 years of age, as most of these children s h o w e d - v e anti-s even after one booster dose.
Introduction: Chronic hepatitis C causes significant morbidity and mortality in Germany. Initial treatment with combination therapy of interferon ce-2b and ribavirin results in a higher sustained virological response rate than with interferon alone but is more expensive. Objective: The objective of this study was to assess the clinical benefits, costs, and costeffectiveness of 24- or 48-week combination therapy versus interferon ~x-2balone as initial treatment for patients with chronic hepatitis C in the German health care system. Methods: After adaptation to the German health care system and the practice patterns of German physicians, a previously published and validated decision-analytic Markov modal was used to project chronic hepatitis C progression for different treatment strategies. Outcome measures included life expectancy, quality-adjusted life expectancy, lifetime direct costs, and cost-effectiveness in Euro per quality-adjusted life-year gained (¢/QALY).Clinical data were derived from two large randomized trials that included 1513 patients. An interviewbased quality-of-life study was performed in 348 patients to assess utilities for different stages of chronic hepatitis C. Detailed data on costs were based on actual variable costs, reimbursement data, and health resource utilization data from 196 chronic hepatitis C patients. Subgroup analyses were performed for age at time of treatment and pretreatment histology. Univariate and multivariate sensitivity analyses were conducted on all model parameters. Results: In 40-year old chronic hepatitis C patients, combination therapy for 24 and 48 weeks increased life expectancy by 1.6 and 2.3 years, respectively, compared with interferon alone for 48 weeks. The discounted incremental cost-effectiveness ratio for combination therapy compared to interferone alone was 5500 g/QALYfor 24 weeks and 6800 UQALY for 48 weeks. Increasing the duration of combination therapy from 24 to 48 weeks resnhed in a cost-effectiveness ratio of 9800 g/QALY. The cost-effectiveness of combination therapy differed for age, liver histology, and duration of treatment. For patients with cirrhosis, combination therapy for 48 weeks was more effective and less expensive than both other treatment regimens. These results were robust, even when effectiveness and cost for treatment and progressed disease, quality-of-life weights, and discount rate were varied in sensitivity analyses. For patients with mild or moderate chronic hepatitis C older than age 65, however, the cost-effectiveness ratio of combination therapy for 48 weeks versus 24 weeks was greater than 50,000 C/QALY.Conclusion: Based upon these decision-analytic estimates for the German health care system, combination therapy with interferon c~-2band ribavirin for 24 or 48 weeks should prolong life, increase quality of life, and be cost-effective compared to other well-accepted treatments in other therapeutic areas, particularly for younger patients.
2057
2058
ELIMINATION OF HEPATITIS B VIRUS INFECTION: RESULTS OF CATCH UP VACCINATION STRATEGIES IN CHILDREN. George H Zacharakis, Evagelia Pouliou, Nikolaos Vafeiadis, Fevronia Tzara, Kostantinos Papoutselis, IKA Alexandroupolis, Alexandroupolis Greece
PERFORMANCE OF ULTRASOUND LOCALIZATION FOR LIVER BIOPSY BY NON-RADIOLOGISTS (HEPATOLOGIST) IS SAFE AND EFFECTIVE. Patrick Lynch, Rebecca Lamparelli, Andres T Blei, Richard M Green, Steve Flamm, Northwestern University, Chicago, IL
Aim: To evaluate the prevalence of hepatitis B virus infection before and after catch-up hepatitis B immunizations in Thrace, located north of Greece. Methods: Sera from 11402 children aged 13-18 years, admitted to the Unit of Preventive Medicine in Alexandroupolis in 1992-1994 and 1998-2000, were tested for the presence of: HBsAg, anti-HBs, and anti-HBc by EIA 2nd and 3ird generation (Abbott Diagnostics). Results: In 1994, the first survey showed high rates of hepatitis B virus infection. To prevent this infection, vaccination was recommended for children aged < 11 years and catch up vaccination for children aged 11-12 years who had not received hepatitis B vaccine (HepB). In 1992-1994 among 7864 sera tested, the anti-HBs were detected in the sera of 550 individuals (7 %), who probably had been vaccinated. Positivity for HBsAg and anti-HBc was detected in 152 sera (1.9 %), which is high, compared to the rest of Greece (up to 1%). Positivity for anti-HBc and anti-HBs was detected in 243 sera (3.1%). In 1998-2000, among 3538 sera tested, 1700 (48.5 %) were negative for all markers. The anti-HBs were detected in the serum of 1581 patients (45%), who had been vaccinated. Positivity for anti-HBc and anti-HBs was detected m 68 sera (1.9%), for HBsAg in 21 (0.6%) and for anti-HBc 30 (0.85%). Conclusions: Our study shows that the 'catch-up' strategies -were successful, since the increase of the percentage of vaccinated adolescents from 7 to 45% produced a significant drop of hepatitis B virus infection in this population from 1.9 to 0,6%. However, the low rates of hepatitis B vaccine coverage in adolescents, as shown in the first survey portend a generation which, as it is too old to benefit from infant programs and school entry laws, will grow in adulthood without the protection of immunization. This study suggests a need for continued focused vaccination programs for progress toward elimination of HBV transmission in Greece, since the Ministry of Health has delayed the implementation of the national immunization program of newborns, which initiated in 1998.
The use of ultrasound localization for liver biopsies has become commonplace at many academic centers, requiring interactions between hepatologists and radiology departments. This technique has been shown to increase the safety of the procedure and to decrease post-biopsy pain. The availability of portableultrasound equipment allows the performance of the biopsy at the bedside or in the office. We reviewed our experience using such ultrasound localization for liver biopsies performed by hepatologists. Methods. All outpatient liver biopsies performed by 4 hepatologists over a 6-month period were included in this review. Ultrasound localization was performed using commercially available equipment (Dymax, TM18), where the viewing screen measures 6.5 x 5 cm and where three depths of insonation can be obtained. All patients had acceptable coagulation parameters and were observed for at least three hours before discharge. A 16 gauge Monopty needle was used in all cases. Two sets of parameters were analyzed. In the first, factors related to ultrasound technique, including the ability to visualize the liver or misdirection of biopsy path. In the second, factors related to the biopsy itself, such as use of narcotics, admission for hospitalization and tissue adequacy for pathologic diagnosis (biopsy sample one cm or greater in length). Results. 110 patients underwent liver biopsy during the study interval. All procedures were performed via the standard right intercostal approach, with one pass made in the majority of subjects. In all subjects, the main anatomic structures, such as the diaphragm, kidney and gallbladder, were easily discerned and did not require additional assistance. Localization was unsuccessful in one patient, a patient with an atrophic right liver lobe; thus, 1% of the group required additional procedures. No complications arose from a misdirected biopsy. Pain requiring meperidine (Demerol) developed in 3 patients (2.7%), 2 of which were admitted for observation. Tissue adequacy as noted by a core greater than 1.0 cm was noted in 104/110 (95%) cases. The median time for the performance of the entire biopsy procedure was 10 minutes. The appropriate billing code was used. Conclusions. Ultrasound localization of the liver by a hepatologist can be easily performed at the bedside using available equipment that does not require specialized training for major organ localization. The procedure provides a safe, effective and time-efficient approach to the performance of liver biopsy.
AASLD ABSTRACTS
HEPATOLOGY October 2001
2055
2056
HEPATITIS B VACCINED CHILDREN AT FIVE YEARS OF AGE IN NEED OF A BOOSTER DOSE. Mohamed A E1 Guindi, Liver Institute, Cairo Egypt; Aleef A Alam, Ahmed A Raouf, Liver Institute, Shebin E1 Kom Egypt
COST-EFFECTIVENESS OF INTERFERON ALFA-2B COMBINED W I T H RIBAVIRIN AS INITIAL TREATMENT OF CHRONIC HEPATITIS C IN THE GERMAN HEALTH CARE SYSTEM. Uwe Siebert, Gaby Sroczynski, Harvard Sch of Public Health, Boston, MA;J(irgen Wasem, Univ of Greifswald, Greifswald Germany; Ulrike Ravens-Sieberer, Robert Koch Inst, Berlin Germany; Wolfgang Greiner, Univ of Hanover, Hanover Germany; B~rbel M Bellach, Robert Koch Inst, Berlin Germany; Pamela Aidelsburger, Univ of Greifswald, Greifswald Germany; Michael Corzillius, Univ of Kiel, Kiel Germany; Monika Bullinger, Univ of Hamburg, Hamburg Germany; J-Matthias Graf von der Schulenburg, Univ of Hanover, Hanover Germany; John B Wong, Tufts Univ Sch of Medicine, Boston, MA; Siegbert Rossol, Univ Hosp of Mannheim, Germany, on behalf of the German Hepatitis C Model (GEHMO) Grp
Objective: Viral hepatitis is a major cause of morbidity and mortality. Hepatitis B and C account for more than 75 percent of the causes for all chronic hepatitis. Hepatitis B vaccination has been implemented in the Egyptian Extended Program for Immunization since 1995. The aim of this work is to study the efficacy of this program and the need for further immunization schedule. Methods: Three hundred neonates immediately after birth were included in the study. Half of them were given 0.5 ml of Engerix-B vaccine and the rest received 0.25 ml of the vaccine at birth, at one month and at six months of age. All proved to be immune against Hepatitis B. After 5 years these children were subjected to clinical evaluation and several investigations including HBsAg, FIBs antibody, HBcAg, HBeAg, anti-HAV, anti-HCV, PCR's, schistosomiasis, mothers profile and others. Results: Two hundred and eighty five child (90.5%) showed negative HBs antibodies while the other 30 children showed positive HBs antibodies at 5 years. Eighty seven of the non-immunized children were given 0.5 ml of the same vaccine to detect their immune response. Originally 30 of these children received 0.25 ml vaccine at birth and the other 57 children received 0.5 ml vaccine at birth. After 45 days from this booster dose, anti-s was repeated. The results revealed that 44 children were converted to positive anti-s and the other 43 remained ant-s negative or non-immunized. The level of antibodies varied greatly in the converted group. Also, a higher number of this converted group was given originally 0.25ml of the vaccine at birth and later on at 1 and 6 months. Therefore, 90% of the vaccinated children showed nondetectable levels of anti-s after 5 years, and 50% of them are in need of more than one dose. Conclusion: There is no difference between 0.25 and 0.5 ml vaccine dose for hepatitis B. All children should receive at least a booster dose of the hepatitis B vaccine at 5 years of age, as most of these children s h o w e d - v e anti-s even after one booster dose.
Introduction: Chronic hepatitis C causes significant morbidity and mortality in Germany. Initial treatment with combination therapy of interferon ce-2b and ribavirin results in a higher sustained virological response rate than with interferon alone but is more expensive. Objective: The objective of this study was to assess the clinical benefits, costs, and costeffectiveness of 24- or 48-week combination therapy versus interferon ~x-2balone as initial treatment for patients with chronic hepatitis C in the German health care system. Methods: After adaptation to the German health care system and the practice patterns of German physicians, a previously published and validated decision-analytic Markov modal was used to project chronic hepatitis C progression for different treatment strategies. Outcome measures included life expectancy, quality-adjusted life expectancy, lifetime direct costs, and cost-effectiveness in Euro per quality-adjusted life-year gained (¢/QALY).Clinical data were derived from two large randomized trials that included 1513 patients. An interviewbased quality-of-life study was performed in 348 patients to assess utilities for different stages of chronic hepatitis C. Detailed data on costs were based on actual variable costs, reimbursement data, and health resource utilization data from 196 chronic hepatitis C patients. Subgroup analyses were performed for age at time of treatment and pretreatment histology. Univariate and multivariate sensitivity analyses were conducted on all model parameters. Results: In 40-year old chronic hepatitis C patients, combination therapy for 24 and 48 weeks increased life expectancy by 1.6 and 2.3 years, respectively, compared with interferon alone for 48 weeks. The discounted incremental cost-effectiveness ratio for combination therapy compared to interferone alone was 5500 g/QALYfor 24 weeks and 6800 UQALY for 48 weeks. Increasing the duration of combination therapy from 24 to 48 weeks resnhed in a cost-effectiveness ratio of 9800 g/QALY. The cost-effectiveness of combination therapy differed for age, liver histology, and duration of treatment. For patients with cirrhosis, combination therapy for 48 weeks was more effective and less expensive than both other treatment regimens. These results were robust, even when effectiveness and cost for treatment and progressed disease, quality-of-life weights, and discount rate were varied in sensitivity analyses. For patients with mild or moderate chronic hepatitis C older than age 65, however, the cost-effectiveness ratio of combination therapy for 48 weeks versus 24 weeks was greater than 50,000 C/QALY.Conclusion: Based upon these decision-analytic estimates for the German health care system, combination therapy with interferon c~-2band ribavirin for 24 or 48 weeks should prolong life, increase quality of life, and be cost-effective compared to other well-accepted treatments in other therapeutic areas, particularly for younger patients.
2057
2058
ELIMINATION OF HEPATITIS B VIRUS INFECTION: RESULTS OF CATCH UP VACCINATION STRATEGIES IN CHILDREN. George H Zacharakis, Evagelia Pouliou, Nikolaos Vafeiadis, Fevronia Tzara, Kostantinos Papoutselis, IKA Alexandroupolis, Alexandroupolis Greece
PERFORMANCE OF ULTRASOUND LOCALIZATION FOR LIVER BIOPSY BY NON-RADIOLOGISTS (HEPATOLOGIST) IS SAFE AND EFFECTIVE. Patrick Lynch, Rebecca Lamparelli, Andres T Blei, Richard M Green, Steve Flamm, Northwestern University, Chicago, IL
Aim: To evaluate the prevalence of hepatitis B virus infection before and after catch-up hepatitis B immunizations in Thrace, located north of Greece. Methods: Sera from 11402 children aged 13-18 years, admitted to the Unit of Preventive Medicine in Alexandroupolis in 1992-1994 and 1998-2000, were tested for the presence of: HBsAg, anti-HBs, and anti-HBc by EIA 2nd and 3ird generation (Abbott Diagnostics). Results: In 1994, the first survey showed high rates of hepatitis B virus infection. To prevent this infection, vaccination was recommended for children aged < 11 years and catch up vaccination for children aged 11-12 years who had not received hepatitis B vaccine (HepB). In 1992-1994 among 7864 sera tested, the anti-HBs were detected in the sera of 550 individuals (7 %), who probably had been vaccinated. Positivity for HBsAg and anti-HBc was detected in 152 sera (1.9 %), which is high, compared to the rest of Greece (up to 1%). Positivity for anti-HBc and anti-HBs was detected in 243 sera (3.1%). In 1998-2000, among 3538 sera tested, 1700 (48.5 %) were negative for all markers. The anti-HBs were detected in the serum of 1581 patients (45%), who had been vaccinated. Positivity for anti-HBc and anti-HBs was detected m 68 sera (1.9%), for HBsAg in 21 (0.6%) and for anti-HBc 30 (0.85%). Conclusions: Our study shows that the 'catch-up' strategies -were successful, since the increase of the percentage of vaccinated adolescents from 7 to 45% produced a significant drop of hepatitis B virus infection in this population from 1.9 to 0,6%. However, the low rates of hepatitis B vaccine coverage in adolescents, as shown in the first survey portend a generation which, as it is too old to benefit from infant programs and school entry laws, will grow in adulthood without the protection of immunization. This study suggests a need for continued focused vaccination programs for progress toward elimination of HBV transmission in Greece, since the Ministry of Health has delayed the implementation of the national immunization program of newborns, which initiated in 1998.
The use of ultrasound localization for liver biopsies has become commonplace at many academic centers, requiring interactions between hepatologists and radiology departments. This technique has been shown to increase the safety of the procedure and to decrease post-biopsy pain. The availability of portableultrasound equipment allows the performance of the biopsy at the bedside or in the office. We reviewed our experience using such ultrasound localization for liver biopsies performed by hepatologists. Methods. All outpatient liver biopsies performed by 4 hepatologists over a 6-month period were included in this review. Ultrasound localization was performed using commercially available equipment (Dymax, TM18), where the viewing screen measures 6.5 x 5 cm and where three depths of insonation can be obtained. All patients had acceptable coagulation parameters and were observed for at least three hours before discharge. A 16 gauge Monopty needle was used in all cases. Two sets of parameters were analyzed. In the first, factors related to ultrasound technique, including the ability to visualize the liver or misdirection of biopsy path. In the second, factors related to the biopsy itself, such as use of narcotics, admission for hospitalization and tissue adequacy for pathologic diagnosis (biopsy sample one cm or greater in length). Results. 110 patients underwent liver biopsy during the study interval. All procedures were performed via the standard right intercostal approach, with one pass made in the majority of subjects. In all subjects, the main anatomic structures, such as the diaphragm, kidney and gallbladder, were easily discerned and did not require additional assistance. Localization was unsuccessful in one patient, a patient with an atrophic right liver lobe; thus, 1% of the group required additional procedures. No complications arose from a misdirected biopsy. Pain requiring meperidine (Demerol) developed in 3 patients (2.7%), 2 of which were admitted for observation. Tissue adequacy as noted by a core greater than 1.0 cm was noted in 104/110 (95%) cases. The median time for the performance of the entire biopsy procedure was 10 minutes. The appropriate billing code was used. Conclusions. Ultrasound localization of the liver by a hepatologist can be easily performed at the bedside using available equipment that does not require specialized training for major organ localization. The procedure provides a safe, effective and time-efficient approach to the performance of liver biopsy.