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Patient Notification System
HIV/AIDS FAQs
Q: How are bleeding disorders, HIV and
AIDS connected?
A: People with bleeding disorders such as hemophilia need to
replace or increase clotting factor proteins that are inactive or partially
inactive in their blood. From about 1978 until approximately 1985, many
of the blood clotting factor products that came from human plasma donors
were contaminated with HIV, the virus that causes AIDS. After 1985, new
viral inactivation technologies made these products virtually free of HIV.
Q: How many people with hemophilia
or other bleeding disorders in the United States are HIV-positive?
A: Among individuals with hemophilia or other bleeding
disorders, 8,540 are known to have received potentially contaminated blood
products between 1978 and 1985. Not all of these people became HIV-positive
as a result (seroconverted). It is difficult to say with any certainty how
many people with bleeding disorders became HIV-positive through use of clotting
factor, but it is possible that as many as 8,000 individuals seroconverted.
Q: How many people with hemophilia or
other bleeding disorders have developed AIDS?
A: As of June 2000, 5,121 people with hemophilia or other bleeding
disorders had developed AIDS. Of this number, 23% were children under 13
years of age.
Q: What are the chances of a person with
a bleeding disorder becoming HIV-positive now versus prior to 1985?
A: Today, factor concentrates are virtually free of HIV due to
viral inactivation technologies including heat treatment, solvent-detergent
cleansing and immunoaffinity purification. No seroconversions to HIV have
been reported with any of the factor products currently marketed in the
United States since 1986. Another type of clotting factor product, cryoprecipitate,
was discovered in the mid-1960s and used as a treatment for factor VIII
deficiency. Cryoprecipitate is a cold-insoluble precipitate that remains
when frozen plasma is thawed at temperatures between 1 and 6 degrees C.
The use of cryoprecipitate as a treatment alternative for factor VIII deficiency
is not recommended. It might still be HIV infectious, as there is no way
to inactivate the virus and retain factor VIII activity in cryoprecipitate.
In this case, there is potential for several months' delay in seroconversion.
Q: How is the blood supply safeguarded
now?
A: Since April of 1985, all blood donations have been tested
for antibodies to HIV-1, the predominant strain of HIV in the United States.
HIV-2 infection of blood and plasma donations is extremely rare. Since
the
implementation of HIV-2 donor blood and source plasma screening in late
1991 and early 1992, only three cases of HIV-2 infection have been detected
in an estimated 74 million donations. Screening of about 20 million blood
donations between 1987 and 1989 revealed no blood donations with HIV-2
antibodies.
In addition to blood donation testing, blood donors are screened prior
to blood donation for risky behaviors associated with HIV infection. With
these
two procedures in place, the current estimate for the risk of HIV transmission
by screened donor blood is one in 500,000. A landmark report on the HIV
contamination of the nation's blood supply and blood products was issued
by a special committee of the National Academy of Sciences' Institute of
Medicine (IOM) in July 1995. The committee found fault with the governmental
handling of the HIV crisis in relation to blood product safety. In October
1995, in response to recommendations contained in the IOM report, Secretary
of Health and Human Services Donna Shalala designated the Assistant Secretary
for Health as the nation's blood safety director "to facilitate leadership
and give priority to blood safety issues at the highest level during times
of crisis and disagreement." This secretary also created a Blood Safety
Council that includes the heads of the Centers for Disease Control and
Prevention,
the Food and Drug Administration and the National Institutes of Health.
The move was intended to prevent the interagency rivalries that hindered
the federal response to AIDS in the 1980s.
Q: Is there an alternative to plasma-derived
factor?
A: Yes. Recombinant factor products are created by recombinant
DNA technology with no use of human blood/plasma donors. During production,
recombinant factor VIII is stabilized in human albumin, but the risk of
human viral contamination is theoretically lower than for products that
are solely plasma derived. In fact, no known cases of viral transmission
have occured with the use of albumin since its introduction into the marketplace
more than 50 years ago. Recombinant factor VIII products were first approved
by the Food and Drug Administration early in 1993. One pharmaceutical company
has recently licensed a recombinant factor VIII product that contains no
human albumin as a stabilizer. However, albumin is used in the initial production
step and then removed. Only trace amounts remain in the final formulation.
This would eliminate the possibility of any viral exposure. In February
1997, the Food and Drug Administration licensed the first recombinant blood
clotting therapy for factor IX deficiency. This product is stabilized without
the addition of human albumin and is free of animal or human protein.
Q: Do people with hemophilia face any
obstacles to gaining access to these recombinant blood products?
A: The most crucial obstacle is the cost of such new products.
The average annual cost of factor products derived from human plasma for
a person with severe hemophilia is approximately $100,000. Recombinant
factor
VIII is priced significantly higher than plasma-derived products. Thus,
lifetime insurance limits ("caps") present significant difficulties for
the use of recombinant products. Additionally, current supply shortages
have prevented some persons with bleeding disorders from being able to
utilize
a recombinant FVIII product.
Q: What is being done to help people with
hemophilia afford the safest possible blood products they need?
A. NHF is working at the federal level to obtain healthcare coverage
for all individuals with bleeding disorders so that equitable reimbursement
for factor products can be made. Additionally, a letter of request for special
consideration has been presented to the Social Security Administration to
change current rules in order to make the application process for Social
Security Cash Assistance Benefits easier for individuals with hemophilia
and HIV and/or chronic or symptomatic hepatitis. Finally, NHF is working
closely with government agencies and pharmaceutical companies to minimize
current recombinant FVIII shortages and to prevent this deficiency from
ever occuring again.
Q: Are people with hemophilia involved
in any clinical trials to test treatments for HIV/AIDS?
A. Under a contract with the federal government, NHF is charged
with establishing and maintaining a system for recruiting eligible HIV-infected
patients with hemophilia and their spouses/sexual partners for studies supported
by the National Institute of Allergies and Infectious Diseases' AIDS Clinical
Trials Group (ACTG) and for following these patients as required by study
protocols. Since 1988, approximately 800 hemophilic patients and their sexual
partners have been enrolled in a total of 23 ACTG studies. Some of the most
important include ACTG 036, which demonstrated in 1989 that administration
of AZT to asymptomatic HIV-positive persons was effective in delaying the
onset of AIDS-related symptoms; ACTG 143, which confirmed the safety and
efficacy of ddI monotherapy and combination therapy with AZT in hemophilic
and nonhemophilic HIV-positive patients; ACTG 203P, which studied the safety
and efficacy of interferon alpha in combination with nucleoside analogue
therapy in persons with hepatitis C and HIV infections; and ACTG 175, which
found that anti-HIV treatment of individuals with intermediate-stage HIV
disease can lower their risk of developing AIDS and, in certain patients,
can reduce the risk of death. Importantly, this study also determined that
treatment with either ddI+AZT or ddI alone was more effective than AZT monotherapy.
Q:
What is NHF's position on HIV testing?
A:
NHF strongly advocates that all people with hemophilia and their
spouses, sexual partners and offspring be voluntarily tested for HIV in
a setting that affords complete confidentiality, education and supportive
counseling. NHF holds this position even more strongly now that it has been
demonstrated that highly active antiretroviral therapy (HAART) including
the use of protease inhibitors and prophylactic treatment for opportunistic
infections can delay the onset of symptomatic illness. Studies also suggest
that knowing one's seropositivity may contribute to more consistent adoption
of risk-reducing behavior.
Q:
What programs does NHF have to help the bleeding disorders community deal
with HIV/AIDS?
A:
Since 1990, HANDI, the NHF information center, has provided information,
resources and referrals on hemophilia and AIDS/HIV to the entire bleeding
disorders community. Information specialists provide guidance on the latest
HIV/hemophilia treatments, psychosocial support, nutrition, and finance
and reimbursement. HANDI produces a variety of publications and maintains
a library of research articles, scholarly journals, HIV and hemophilia-related
newsletters, books and videos.
Q:
Have people with hemophilia experienced discrimination due to their HIV
status?
A:
Historically, people with hemophilia experienced some
discrimination—from schools, employers and insurance companies—due
to a fear of or lack of understanding about this genetic disorder. Although
hemophilia is a lifelong, chronic condition, it is treatable, and people
with hemophilia live productive lives and are fully contributing members
of society. With the additional burden of HIV/AIDS, people with hemophilia
are subject to many of the same fears and threats or hostility and isolation
as other HIV-affected groups. However, there has been considerable progress
since the 1980s, when many people, such as the Ray family and Ryan White,
were the objects of blatant discrimination and ignorance.
Q:
Is there research being done to find a cure for hemophilia?
A: The major hopes for a cure for hemophilia lie in gene
therapy, a procedure that would introduce manufactured genes into the body's
cells to make up for the genes that cause hemophilia. Hemophilia appears
to be a good candidate for the procedure, since
1) the genes that make clotting factor have been identified and duplicated;
2) the amount of clotting factor produced does not need to be high nor stringently
monitored since there seems to be little harm in causing overproduction
of clotting factor and even a small boost in clotting activity can be therapeutic;
and
3) clotting factor genes do not have to be delivered to a particular site
in the body but can be introduced into any cell with access to the bloodstream.
Disclaimer
The information contained on the NHF web site is provided for your general
information only. NHF does not give medical advice or engage in the practice
of medicine. NHF under no circumstances recommends particular treatment
for specific individuals and in all cases recommends that you consult your
physician or local treatment center before pursuing any course of treatment.
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