Lack of Transmission of Human Immunodeficiency Virus
Through Rho(D) Immune Globulin (Human)
On September 18, 1987, the Armed Forces Medical Logistical
Office
issued instructions to temporarily suspend from distribution and
use
in military hospitals one lot (RHG 636) of RhoGAM* Rho(D) Immune
Globulin (human) (Rh-IG), manufactured by Ortho Diagnostic Systems,
Inc. This action was taken because a woman on active duty who had
received an injection from the lot was subsequently found to be
infected with human immunodeficiency virus (HIV). The woman
received
RhoGAM lot RHG 636 in September 1986, prior to the birth of her
second
child in December 1986. In addition, she had received an earlier
injection of Rh-IG from a different lot in May 1985, prior to the
birth of her first child.
The woman was first tested for HIV in November 1986 as part of
the
military screening program and was found to be seropositive for HIV
antibodies at that time. At present, she remains seropositive with
evidence of severe immunodeficiency but has not developed AIDS. Her
first child, born in July 1985, was negative for HIV antibodies
when
tested in January 1987. Her second child tested positive for HIV
antibodies at birth, but subsequent serologic testing performed at
9
months of age was negative, reflecting the loss of passively
derived
maternal antibody and the absence of infection.
An epidemiologic investigation determined that this woman very
likely had a behavioral risk factor for infection with HIV. Samples
of
both Rh-IG lots from which the woman had received treatment have
been
studied by the U.S. Food and Drug Administration. They have been
found
to be free of anti-HIV antibodies. Lot RHG 636 was also tested and
found to be free of HIV antigen. In addition, review of the
manufacturer's records for RhoGAM lot RHG 636 confirmed that all
plasma used for that lot had been screened for antibodies to HIV
and
found negative and that all steps in its manufacture were in
accordance with good manufacturing practices.
Reported by: Center for Drugs and Biologics, Food and Drug
Administration. Office of the Surgeon General, US Army. AIDS
Program,
Center for Infectious Diseases, CDC.
Editorial Note
Editorial Note: Approximately 500,000 doses of Rh-IG are
administered annually to an estimated 350,000 women in the United
States. Rh-IG and other immune globulins used in the United States
are
produced by several manufacturers using one of the modifications of
the Cohn-Oncley fractionation process (1,2), which has been shown
to
be effective in removing HIV by partitioning and inactivation (3).
Since late April 1985, all units of plasma for production of Rh-IG
have been screened for antibodies to HIV, and all repeatedly
reactive
units have been discarded. Several epidemiologic and laboratory
studies have shown that recipients of hepatitis B immune globulin
(HBIG) and immune globulin (IG), including recipients of lots
manufactured before April 1985, have not developed either antibody
responses indicative of HIV infection or clinical illness
associated
with HIV infection (4). Low levels of passively acquired HIV
antibody
from some preparations of HBIG that were known to contain high
levels
of HIV antibody have been reported, but this passively transferred
HIV
antibody has not persisted longer than 6 months (5).
Based on the history of the safety of IG products, the
investigation of this case (which strongly suggests that the woman
was
exposed to HIV through other means), and the lack of evidence of
HIV
infection associated with Rh-IG despite receipt of these products
by
more than 350,000 women annually, there is no evidence to implicate
this product as a source of HIV infection nor to change current
recommendations for its use and administration. References
Cohn EJ, Strong LE, Hughes WL Jr, et al. Preparation and
properties of serum and plasma proteins. IV: A system for the
separation into fractions of the protein and lipoprotein
components of biological tissues and fluids. J Am Chem Soc
1946;68:459-75.
Oncley JL, Melin M, Richert DA, Cameron JW, Gross PM Jr. The
separation of the antibodies, isoagglutinins, prothrombin,
plasminogen and beta1-lipoprotein into subfractions of human
plasma. J Am Chem Soc 1949;71:541-50.
Wells MA, Wittek AE, Epstein JS, et al. Inactivation and
partition
of human T-cell lymphotrophic virus, type III, during ethanol
fractionation of plasma. Transfusion 1986;26:210-3.
Centers for Disease Control. Safety of therapeutic immune
globulin
preparations with respect to transmission of human
T-lymphotropic
(sic) virus type III/lymphadenopathy-associated virus
infection.
MMWR 1986;35:231-3.
Tedder RS, Uttley A, Cheingsong-Popov R. Safety of
immunoglobulin
preparation containing anti-HTLV-III (Letter). Lancet
1985;1:815.
*Use of trade names is for identification only and does not imply
endorsement by the U.S. Department of Health and Human Services or
the
Public Health Service.
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