Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0019158 (hepatitis)
 30,205 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

An outbreak of non-A, non-B hepatitis was recognized among cardiovascular surgical patients from one hospital in June 1985. Illness was found to be significantly associated with a commercial brand of factor IX complex given to patients because of intraoperative bleeding. A change in the commercial brand of factor IX stocked by the hospital pharmacy had occurred in October 1984 and coincided with the onset of the outbreak. A retrospective study of cardiovascular surgery patients identified 23 cases and 7 probable cases of non-A, non-B hepatitis among patients who had received infusions of brands A and B factor IX complex. Three cases were in brand A recipients and 27 were in brand B recipients. Respective brand-specific attack rates were 5 and 42% (relative risk = 7.7; p less than 2 x 10(-5); chi 2 test). Nineteen of 30 case patients (63%) were jaundiced, including 2 brand A recipients and 17 brand B recipients. Median peak serum aminotransferase was 690.5 IU (range 27-2,824). The incubation period for cases in brand B recipients was a median of 7 weeks (range 2-17 weeks). Prevention of non-A, non-B hepatitis in this population requires adhering to strict indications for the use of clotting factor preparations and avoiding these products when at all possible. Heat treatment of clotting factor products may reduce the risk of viral disease transmission, but certain methods may not inactivate the causative agents of non-A, non-B hepatitis.
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PMID:An outbreak of non-A, non-B hepatitis associated with the infusion of a commercial factor IX complex during cardiovascular surgery. 211 87

Heat treatment of lyophilized factor VIII and factor IX concentrates has been found to eliminate HIV virus infectivity in plasma-derived products. Pasteurization of factor VIII in solution has recently been used to reduce the risk of hepatitis transmission in concentrates prepared by standard fractionation methods. This report presents early experience with factor VIIIC prepared by monoclonal antibody immunoaffinity chromatography following pasteurization of the factor VIIIC/von Willebrand factor complex (Monoclate-P). Twelve patients were treated in three centers with Monoclate-P. Recovery and survival of factor VIII clotting activity were determined and patients were closely monitored for infusion safety. The mean half-life was 14.2 +/- 5.0 while recovery in predicted plasma volume was 72 +/- 12% corresponding to a response of 1.99 +/- 0.66 U/dL for every U/kg administered. These values are very similar to those found for Monoclate in previous studies indicating that pasteurized factor VIIIC purified by immunoaffinity chromatography retains satisfactory pharmacokinetic properties with an added margin of viral safety.
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PMID:Initial clinical experience with a new pasteurized monoclonal antibody purified factor VIIIC. 212 55

Earlier commercial clotting factor concentrates transmitted hepatitis viruses to 100% and acquired immunodeficiency syndrome viruses to 60% to 80% of patients with hemophilia. Transmission of the human immunodeficiency virus was nearly eliminated by heating concentrates in the lyophilized state, which has been done since 1983. However, human immunodeficiency virus infections were still transmitted by some products "dry heated" under conditions less extreme than 68 degrees C for 72 hours. Newer virus-inactivating procedures include "dry heating" at 80 degrees C for 72 hours, modified heating in n-heptane or water vapor, heating in solution, treatment with solvent-detergent mixtures, monoclonal affinity purification plus inactivation, and alkylation with beta-propiolactone (only for factor IX complex). These procedures have eliminated significant loads of human immunodeficiency virus, hepatitis B virus, and non-A, non-B hepatitis virus in laboratory studies. However, clinical studies have shown transmission of hepatitis non-A, non-B for products "dry heated" except at 80 degrees C and for products heated in n-heptane. Elimination of hepatitis B has been difficult to demonstrate, suggesting a continued need for immunization.
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PMID:Current safety of clotting factor concentrates. 212 21

Factor IX is a vitamin K-dependent blood clotting zymogen that is functionally defective or absent in patients with hemophilia B. A method of immunoaffinity chromatography has been developed for a one-step high yield purification of factor IX directly from plasma. The technique utilizes conformation-specific antibodies that bind solely to the metal-stabilized factor IX conformer, but not to the conformer of factor IX found in the absence of metal ions. Anti-factor IX-Ca(II) antibodies were immobilized on an agarose matrix. Human plasma in the presence of 7.5 mM MgCl2 was applied to the antibody-agarose column. The factor IX that binds to these antibodies was specifically eluted by metal chelation with EDTA. This immunopurification resulted in a 10,000-fold one-step purification of the fully functional zymogen. Purified factor IX yielded a single band upon gel electrophoresis in Na-DodSO4 and had a specific activity of 120-150 units/mg. The purified factor IX was separated from other vitamin K-dependent blood clotting proteins and hepatitis virus; no activated factor IX was detected. This method has application for the large scale purification of factor IX for the treatment of hemophilia B.
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PMID:Immunoaffinity purification of factor IX (Christmas factor) by using conformation-specific antibodies directed against the factor IX-metal complex. 240 69

32 patients with coagulation factor deficiencies and likely to be susceptible to non-A, non-B hepatitis (NANBH) virus infection were treated with a total of 20 batches of a factor VIII concentrate and 10 batches of a factor IX concentrate, both heated at 80 degrees C for 72 h in the freeze-dried state. Serial measurements of serum aminotransferase levels for 4 months revealed no patterns of rises attributable to NANBH. Severe dry heating appears to have reduced the risk of NANBH transmission from about 90% in untreated concentrates to a statistically determined rate of 0-9%. No evidence was found in recipients of infection with hepatitis B or human immunodeficiency virus.
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PMID:Effect of dry-heating of coagulation factor concentrates at 80 degrees C for 72 hours on transmission of non-A, non-B hepatitis. Study Group of the UK Haemophilia Centre Directors on Surveillance of Virus Transmission by Concentrates. 290 65

Haemophilia B, or Christmas disease, is an inherited X-chromosome-linked bleeding disorder caused by a defect in clotting factor IX and occurs in about 1 in 30,000 males in the United Kingdom. Injection of factor IX concentrate obtained from blood donors allows most patients to be successfully managed. However, because of impurities in the factor IX concentrate presently in use, this treatment involves some risk of infection by blood-borne viruses such as non-A, non-B hepatitis and the virus causing acquired immune deficiency syndrome (AIDS). Because of the recent concern about the increasing incidence of AIDS amongst haemophiliacs, a factor IX preparation derived from a source other than blood is desirable. Here, we report that after introduction of human factor IX DNA clones into a rat hepatoma cell line using recombinant DNA methods, we were able to isolate small amounts of biologically active human factor IX.
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PMID:Expression of active human clotting factor IX from recombinant DNA clones in mammalian cells. 298

Short presentation of the common procedures to avoid transmission of human-immunodeficiency-virus (HIV) by hemoderivates especially clotting-factor-preparations. The stepwise seroconversion (ELISA, IFT, Western-blot) of HIV is shown in a 7 5/12 ys old boy with hemophilia A after administration of a dry-heated factor VIII-preparation. Seven similar observations were reported in the literature. On the other hand HIV-seroconversion could not be observed during treatment with wet-heated factor VIII-preparations. In consequence only wet-heated factor VIII-preparations and factor IX-preparations respectively should be administered to hemophiliacs without HIV-antibodies. By this precaution transmission of non-A, non-B-hepatitis may be avoided simultaneously.
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PMID:[Transmission of the human immunodeficiency virus by a dry heat-treated Factor VIII concentrate?]. 314 70

The efficiency of heat treatment procedures of factor VIII and factor IX concentrates, prepared from voluntary, non-paid donors by three French Blood Transfusion Centres, on the inactivation of HIV and non-A, non-B hepatitis (NANB) viruses was assessed. Some 43 patients (26 haemophilia A, 17 haemophilia B) were followed for at least 1 year by testing for HIV antibodies and alanine aminotransferase (ALT). No HIV seroconversion was observed indicating that heat treatment was completely efficient. Among 26 haemophiliacs, 6 (4 haemophilia A, 2 haemophilia B) presented an elevation in ALT, indicating only a 75% reduction of NANB viral contamination.
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PMID:Clinical and biological survey of haemophilia A and B patients infused with French heat-treated concentrates. 314 99

Hemophilia B is an X-chromosome-linked bleeding disorder resulting from lack of clotting factor IX activity and affects about 1 in 30,000 males. Current therapy involves injection of crude factor IX prepared from pooled human plasma. Treatment is complicated by viral contaminants in factor IX preparations, such as non A-non B hepatitis and the AIDS virus, and by the practical difficulties of chronic injections. An alternative therapy might include the insertion of a factor IX expression vector into the somatic cells of affected individuals to allow continued production of factor IX. Toward this end, we have constructed a retrovirus vector for transfer and expression of factor IX. Despite the fact that factor IX is normally synthesized in hepatocytes and requires extensive post-translational modification for activity, we have shown that fully active factor IX can be made by human skin-derived fibroblasts. These results open the way to testing the use of skin grafts for gene therapy of hemophilia B.
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PMID:Towards gene therapy for hemophilia B. 347 25

Sterilization of human plasma with beta-propiolactone and UV-irradiation (cold sterilization) has been shown to be effective for a number of common pathogenic viruses. We have published data on the hepatitis safety of cold sterilized factor IX concentrates (PPSB) in healthy volunteers. This study has now been extended to include 6 virgin hemophilia B patients, who have been treated with cold sterilized PPSB for a period of up to 5 years. None of these volunteers or patients exhibited clinical symptoms or laboratory data indicating the transmission of either viral hepatitis (B or NANB) or acquired immunodeficiency syndrome (AIDS). Hyperimmunoglobulin (HIg) preparations from cold sterilized plasma, offering protection against hepatitis B and NANB are also safe regarding HTLV-III virus transmission, even though these preparations may contain HTLV-III antibody titers up to 1:1000.
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PMID:Virus safety of beta-propiolactone treated plasma preparations. Clinical experiences. 364 16


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