Hemophilia A Clinical Trial
Official title:
Prevalence and Consequences of Hepatitis Delta Virus Infection in Hemophiliacs
To elucidate the role of hepatitis delta virus (HDV) in the development of chronic liver disease in patients with hemophilia.
BACKGROUND:
Patients with classical hemophilia (hemophilia A) and Christmas disease (hemophilia B) were
exposed to many hepatotropic viruses during the course of their therapy. Severe chronic
hepatitis among these patients was most likely related to persistent infection with non-A,
non-B hepatitis virus, hepatitis B virus, or delta hepatitis virus, a defective RNA virus
which is dependent upon coinfection with HBV for essential helper functions. Carriers of HBV
could contract an acute delta hepatitis infection that was invariably more severe than the
illness caused by HBV alone. The morbidity and mortality of delta hepatitis infection was
remarkably high. Transmission of the delta hepatitis agent appeared to follow the same
routes of transmission as HBV. Direct parenteral inoculation was the classic mode of
transmission of HBV which suggested a similar mode of transmission for delta hepatitis.
In 1986, hemophiliacs treated with commercial concentrates of coagulation factors prepared
from pools of plasma were at great risk to contract delta hepatitis infection. About 50
percent of these patients had delta hepatitis virus antibodies. Also, studies of small
cohorts indicated that hepatitis delta infection was a major cause of chronic liver disease
and cirrhosis. Therefore, there was a critical need to evaluate the frequency and effect of
hepatitis delta infection in hemophiliacs, comparing those with presumed chronic non-A,
non-B hepatitis, chronic hepatitis B alone, and combined chronic delta and HBV infections.
The project was awarded in response to a Request for Applications issued in 1986 on The
Prevalence and Consequences of Hepatitis Delta Infection in Hemophiliacs. The concept for
the initiative originated in the Blood Resources Working Group of the Blood Diseases and
Resources Advisory Committee and was approved by The National Heart, Lung, and Blood,
Advisory Council in February 1985.
DESIGN NARRATIVE:
The study was conducted collaboratively within the seven hemophilia treatment centers which
comprised the Southeastern Hemophilia Group. Upon entry into the study, patient data were
collected on transfusion and factor concentrate therapy, age, race, type of hemophilia, sex,
homosexuality, drug abuse and HTLV-III antibody status. Liver function was assessed
noninvasively. Since available tests for HDV infection had limited sensitively and were not
necessarily specific for HDV persistence, HDV RNA was detected in serum by molecular
hybridization using cloned HDV cDNA and single-stranded RNA probes. Western blot analysis
was used to assess antibody responses to HDV. A multifactorial analysis of clinical and
virological data was conducted at the end of the first year of the study. Patients were
reevaluated clinically and virologically at six month intervals to ascertain risk factors
for acquisition of HBV and HDV infections, and to assess the prevalence and rate of
progression of liver disease in each group. Follow-up of patients who had not been
previously transfused, allowed an assessment of the efficacy of current control measures
such as HBV immunization and use of heat-treated factor concentrates for prevention of viral
infections in hemophiliacs.
Plans for extended follow-up of HDV-infected vs non-infected subjects were confounded by the
unexpected emergence of human immunodeficiency virus infection in the hemophilic subjects
who comprised the study population.
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