Guest guest Posted April 9, 2000 Report Share Posted April 9, 2000 -------------------------------------------------------------------------------- The New England Journal of Medicine -- September 2, 1999 -- Vol. 341, No. 10 Clinical Outcomes after Hepatitis C Infection from Contaminated Anti-D Immune Globulin -------------------------------------------------------------------------------- To the Editor: In the report by Kenny-Walsh and the Irish Hepatology Research Group (April 22 issue) (1) on the outbreak of hepatitis C in Ireland in 1977 associated with the administration of anti-D immune globulin contaminated with hepatitis C virus (HCV), Table 1 lists the estimated number of recipients of anti-D immune globulin on the basis of the estimated number of vials issued and the number of recipients tested. We would like to supply more precise details. Overall, 21,603 persons who indicated that they had received anti-D immune globulin between 1977 and 1979 have been screened for HCV by the Irish Blood Transfusion Service Board. Owing to the lack of complete records when the screening program began in 1994, the HCV-testing program was a self-referral one, which offered testing to all recipients of anti-D immune globulin. The total therefore includes persons who received contaminated anti-D immune globulin and those who received uncontaminated immune globulin as well as a considerable number who did not receive anti-D immune globulin, either because it was not required during that pregnancy or because they were, in fact, Rh-positive. A total of 795 have been found to be positive for HCV antibody, and 413 had positive results on polymerase-chain-reaction testing. Twelve batches, constituting 4062 vials, of contaminated or potentially contaminated anti-D immune globulin were in circulation in 1977 through 1979 (the batches had an expiration date of mid-1979). Since a small number of persons were known to have received multiple doses, the maximal number of possible recipients was 3951. To date, the formal process to identify those who received HCV-contaminated or potentially HCV-contaminated vials has resulted in the identification of 2592 such persons (66 percent of those exposed), of whom 2352 (91 percent) have been tested. It is therefore likely that the estimate of Kenny-Walsh and colleagues that 94 percent of those exposed will have been tested will be met. We have analyzed in detail a subgroup of 1342 tested recipients using record cards that list the batch of anti-D immune globulin and information about the recipient, which were compiled at the time the immune globulin was administered. We found that the infectivity of the batches varied considerably, ranging from 60 percent to 0.7 percent, with an overall infectivity of 25 percent. (2) Emer Lawlor, F.R.C.Path. Grainne Columb, M.B., B.Ch. Blood Transfusion Service Board Dublin 4, Ireland References 1. Kenny-Walsh E. Clinical outcomes after hepatitis C infection from contaminated anti-D immune globulin. N Engl J Med 1999;340:1228-33. Return to Text 2. Lawlor E, Power J, Garson JA, et al. Transmission rates of hepatitis C virus by different batches of a contaminated anti-D immunoglobulin preparation. Vox Sang 1999;76:138-43. Return to Text -------------------------------------------------------------------------------- To the Editor: The Irish Hepatology Research Group found a relatively low prevalence of severe liver disease and HCV viremia among women who had been infected with contaminated anti-D immune globulin, as compared with other cohorts. After an average of 17 years of infection, cirrhosis had developed in only 2 percent. Furthermore, only 55 percent of those with antibodies against HCV tested positively for HCV RNA, in contrast to the much higher percentages in other reports. The authors speculate that the mode of infection may be an important variable in determining disease outcome. A similarly low rate of disease progression was reported in a study of 152 women who had been infected with HCV after receiving contaminated anti-D immune globulin. (1) Another possible explanation for these outcomes is that the immune globulin itself attenuated the acute infection. Attenuation of acute infection associated with polyclonal immunoglobulin has been reported in a number of viral infections, including hepatitis A and B. Unlike hepatitis B, hepatitis C has no effective immunoglobulin prophylaxis. However, it has been hypothesized that passive immunization with polyclonal immunoglobulins containing anti-HCV antibodies protected against recurrent HCV viremia and new HCV infection in liver-transplant recipients. (2) Furthermore, the presence of high titers of antibodies that inhibit binding of the HCV envelope to human cells has been associated with natural resolution of chronic hepatitis C. (3) It is likely that anti-D immune globulin preparations used in the 1970s contained immunoglobulins against hepatitis C, some of which may have had these neutralizing properties. (4) A.L. Bonis, M.D. New England Medical Center Boston, MA 02111 References 1. Muller R. The natural history of hepatitis C: clinical experiences. J Hepatol 1996;24:Suppl:52-4. Return to Text 2. Feray C, Gigou M, D, et al. Incidence of hepatitis C in patients receiving different preparations of hepatitis B immunoglobulins after liver transplantation. Ann Intern Med 1998;128:810-6. Return to Text 3. Ishii K, D, Watanabe Y, et al. High titers of antibodies inhibiting the binding of envelope to human cells correlate with natural resolution of chronic hepatitis C. Hepatology 1998;28:1117-20. Return to Text 4. Kusnierz G, Walewska I, Maczynska-Rusiniak B, Kacperska E, Gloskowska Z, Madalinski K. Study of anti-RH(D) immunoglobulin for the presence of antibodies with different properties. Acta Haematol Pol 1977;8:281-7. (In Polish.) Return to Text -------------------------------------------------------------------------------- The authors reply: To the Editor: We welcome the very useful clarification data provided by Drs. Lawlor and Columb. The comparatively mild clinical course of the HCV RNA-positive women is consistent with the estimated infectivity of 25 percent for those exposed to anti-D immune globulin contaminated with HCV. Dr. Bonis addresses the low prevalence of severe disease in our study population and raises the possibility of attenuation of the acute infection by the immune globulin preparation. Although his interesting hypothesis might be explored further, we again suggest that the relatively good outcome reported in our paper may have been the result of a single exposure (in the vast majority of cases) with a comparatively small infectious dose unaccompanied by the immunosuppressant effects of blood transfusion. Kenny-Walsh, M.D. Crowley, Ph.D. Fergus Shanahan, M.D. University College Cork Cork, Ireland Vox Sang 1999;76(3):175-80 Related Articles, Books, LinkOut -------------------------------------------------- A second outbreak of hepatitis C virus infection from anti-D immunoglobulin in Ireland. DB, Lawlor E, Power J, O'Riordan J, McAllister J, Lycett C, son F, Pathirana S, Garson JA, Tedder RS, Yap PL, Simmonds P Department of Medical Microbiology, University of Edinburgh, Medical School, Edinburgh, UK. .B.@... OBJECTIVE: To investigate the infectivity for hepatitis C virus (HCV) of intravenous anti-D immunoglobulin batches manufactured in Ireland between 1991 and 1994. METHODS: Women who had received anti-D manufactured between 1991 and 1994 were screened for serological markers of HCV infection and for the presence of HCV RNA by RT-PCR amplification and virus genotyping. RESULTS: 44 women exposed to anti-D manufactured between 1991 and 1994 were polymerase chain reaction positive for HCV RNA, 19 of whom were infected with genotype 3a virus shown by phylogenetic analysis of the NS5B gene to be closely related to that from the single implicated donor. CONCLUSIONS: Anti-D manufactured in 1991-1994 transmitted infection of HCV genotype 3a. The prevalence of HCV-specific antibody in anti-D recipients was relatively low (0.59%), consistent with the low level of virus RNA in these anti-D batches. Publication Types: Clinical trial PMID: 10341334, UI: 99274651 ______________________________________________________ Get Your Private, Free Email at http://www.hotmail.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 9, 2000 Report Share Posted April 9, 2000 -------------------------------------------------------------------------------- The New England Journal of Medicine -- September 2, 1999 -- Vol. 341, No. 10 Clinical Outcomes after Hepatitis C Infection from Contaminated Anti-D Immune Globulin -------------------------------------------------------------------------------- To the Editor: In the report by Kenny-Walsh and the Irish Hepatology Research Group (April 22 issue) (1) on the outbreak of hepatitis C in Ireland in 1977 associated with the administration of anti-D immune globulin contaminated with hepatitis C virus (HCV), Table 1 lists the estimated number of recipients of anti-D immune globulin on the basis of the estimated number of vials issued and the number of recipients tested. We would like to supply more precise details. Overall, 21,603 persons who indicated that they had received anti-D immune globulin between 1977 and 1979 have been screened for HCV by the Irish Blood Transfusion Service Board. Owing to the lack of complete records when the screening program began in 1994, the HCV-testing program was a self-referral one, which offered testing to all recipients of anti-D immune globulin. The total therefore includes persons who received contaminated anti-D immune globulin and those who received uncontaminated immune globulin as well as a considerable number who did not receive anti-D immune globulin, either because it was not required during that pregnancy or because they were, in fact, Rh-positive. A total of 795 have been found to be positive for HCV antibody, and 413 had positive results on polymerase-chain-reaction testing. Twelve batches, constituting 4062 vials, of contaminated or potentially contaminated anti-D immune globulin were in circulation in 1977 through 1979 (the batches had an expiration date of mid-1979). Since a small number of persons were known to have received multiple doses, the maximal number of possible recipients was 3951. To date, the formal process to identify those who received HCV-contaminated or potentially HCV-contaminated vials has resulted in the identification of 2592 such persons (66 percent of those exposed), of whom 2352 (91 percent) have been tested. It is therefore likely that the estimate of Kenny-Walsh and colleagues that 94 percent of those exposed will have been tested will be met. We have analyzed in detail a subgroup of 1342 tested recipients using record cards that list the batch of anti-D immune globulin and information about the recipient, which were compiled at the time the immune globulin was administered. We found that the infectivity of the batches varied considerably, ranging from 60 percent to 0.7 percent, with an overall infectivity of 25 percent. (2) Emer Lawlor, F.R.C.Path. Grainne Columb, M.B., B.Ch. Blood Transfusion Service Board Dublin 4, Ireland References 1. Kenny-Walsh E. Clinical outcomes after hepatitis C infection from contaminated anti-D immune globulin. N Engl J Med 1999;340:1228-33. Return to Text 2. Lawlor E, Power J, Garson JA, et al. Transmission rates of hepatitis C virus by different batches of a contaminated anti-D immunoglobulin preparation. Vox Sang 1999;76:138-43. Return to Text -------------------------------------------------------------------------------- To the Editor: The Irish Hepatology Research Group found a relatively low prevalence of severe liver disease and HCV viremia among women who had been infected with contaminated anti-D immune globulin, as compared with other cohorts. After an average of 17 years of infection, cirrhosis had developed in only 2 percent. Furthermore, only 55 percent of those with antibodies against HCV tested positively for HCV RNA, in contrast to the much higher percentages in other reports. The authors speculate that the mode of infection may be an important variable in determining disease outcome. A similarly low rate of disease progression was reported in a study of 152 women who had been infected with HCV after receiving contaminated anti-D immune globulin. (1) Another possible explanation for these outcomes is that the immune globulin itself attenuated the acute infection. Attenuation of acute infection associated with polyclonal immunoglobulin has been reported in a number of viral infections, including hepatitis A and B. Unlike hepatitis B, hepatitis C has no effective immunoglobulin prophylaxis. However, it has been hypothesized that passive immunization with polyclonal immunoglobulins containing anti-HCV antibodies protected against recurrent HCV viremia and new HCV infection in liver-transplant recipients. (2) Furthermore, the presence of high titers of antibodies that inhibit binding of the HCV envelope to human cells has been associated with natural resolution of chronic hepatitis C. (3) It is likely that anti-D immune globulin preparations used in the 1970s contained immunoglobulins against hepatitis C, some of which may have had these neutralizing properties. (4) A.L. Bonis, M.D. New England Medical Center Boston, MA 02111 References 1. Muller R. The natural history of hepatitis C: clinical experiences. J Hepatol 1996;24:Suppl:52-4. Return to Text 2. Feray C, Gigou M, D, et al. Incidence of hepatitis C in patients receiving different preparations of hepatitis B immunoglobulins after liver transplantation. Ann Intern Med 1998;128:810-6. Return to Text 3. Ishii K, D, Watanabe Y, et al. High titers of antibodies inhibiting the binding of envelope to human cells correlate with natural resolution of chronic hepatitis C. Hepatology 1998;28:1117-20. Return to Text 4. Kusnierz G, Walewska I, Maczynska-Rusiniak B, Kacperska E, Gloskowska Z, Madalinski K. Study of anti-RH(D) immunoglobulin for the presence of antibodies with different properties. Acta Haematol Pol 1977;8:281-7. (In Polish.) Return to Text -------------------------------------------------------------------------------- The authors reply: To the Editor: We welcome the very useful clarification data provided by Drs. Lawlor and Columb. The comparatively mild clinical course of the HCV RNA-positive women is consistent with the estimated infectivity of 25 percent for those exposed to anti-D immune globulin contaminated with HCV. Dr. Bonis addresses the low prevalence of severe disease in our study population and raises the possibility of attenuation of the acute infection by the immune globulin preparation. Although his interesting hypothesis might be explored further, we again suggest that the relatively good outcome reported in our paper may have been the result of a single exposure (in the vast majority of cases) with a comparatively small infectious dose unaccompanied by the immunosuppressant effects of blood transfusion. Kenny-Walsh, M.D. Crowley, Ph.D. Fergus Shanahan, M.D. University College Cork Cork, Ireland Vox Sang 1999;76(3):175-80 Related Articles, Books, LinkOut -------------------------------------------------- A second outbreak of hepatitis C virus infection from anti-D immunoglobulin in Ireland. DB, Lawlor E, Power J, O'Riordan J, McAllister J, Lycett C, son F, Pathirana S, Garson JA, Tedder RS, Yap PL, Simmonds P Department of Medical Microbiology, University of Edinburgh, Medical School, Edinburgh, UK. .B.@... OBJECTIVE: To investigate the infectivity for hepatitis C virus (HCV) of intravenous anti-D immunoglobulin batches manufactured in Ireland between 1991 and 1994. METHODS: Women who had received anti-D manufactured between 1991 and 1994 were screened for serological markers of HCV infection and for the presence of HCV RNA by RT-PCR amplification and virus genotyping. RESULTS: 44 women exposed to anti-D manufactured between 1991 and 1994 were polymerase chain reaction positive for HCV RNA, 19 of whom were infected with genotype 3a virus shown by phylogenetic analysis of the NS5B gene to be closely related to that from the single implicated donor. CONCLUSIONS: Anti-D manufactured in 1991-1994 transmitted infection of HCV genotype 3a. The prevalence of HCV-specific antibody in anti-D recipients was relatively low (0.59%), consistent with the low level of virus RNA in these anti-D batches. Publication Types: Clinical trial PMID: 10341334, UI: 99274651 ______________________________________________________ Get Your Private, Free Email at http://www.hotmail.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 9, 2000 Report Share Posted April 9, 2000 wow.. well i got my rho gam shots (4 or 5 total) in 75. alley/ ICQ 12631861 alleypat@... http://www.flash.net/~alleypat Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 9, 2000 Report Share Posted April 9, 2000 wow.. well i got my rho gam shots (4 or 5 total) in 75. alley/ ICQ 12631861 alleypat@... http://www.flash.net/~alleypat Quote Link to comment Share on other sites More sharing options...
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