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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

______________________________________________________

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Link to comment
Share on other sites

Guest guest

--------------------------------------------------------------------------------

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

Link to comment
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