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Transmission of Hepatitis C Virus Infection Associated With Home Infusion Therapy for Hemophilia

Transmission of hepatitis C virus (HCV) and other bloodborne viruses between household members who are not sex partners presumably results from inapparent percutaneous or permucosal exposures, such as sharing articles that may be contaminated with microscopic quantities of blood. The risk for nonsexual household transmission is extremely low, and no cases of such transmission have been documented (1); direct percutaneous exposures (e.g., injecting drugs) have been identified as the major risk factor for infection (1). This report summarizes the investigation of a newly acquired case of HCV infection in a child with hemophilia, after a preliminary investigation identified several household members with HCV infection. The findings suggest the child acquired infection through percutaneous exposure to the mother's HCV-infected blood during infusion of clotting-factor concentrate.

On September 12, 1996, a case of seroconversion of antibody to HCV (anti-HCV) in a 4-year-old child with moderate factor VIII deficiency was reported to the Seroconversion Surveillance Project, a surveillance system maintained jointly by the Food and Drug Administration, CDC, and the National Hemophilia Foundation. The child tested positive for anti-HCV on August 29, 1996, after testing negative in June 1994 and August 1995. Serum drawn on the same day (August 29) tested negative for human immunodeficiency virus (HIV) antibody. With the exception of the 14 days after birth, the child had always received recombinant clotting-factor concentrate for treatment of bleeding episodes.

Testing of serum samples from six household members indicated that three were anti-HCV-positive, including the patient's mother, an older sibling, and an aunt who had stayed in the household for 6 weeks during September-October 1995. The mother and aunt had histories of having injected illicit drugs but had not been tested previously for anti-HCV. The sibling, aged 11 years, had moderate factor VIII deficiency and was anti-HCV-positive when first tested in 1992.

Until November 1994, the child was treated for bleeding episodes at a local emergency department with recombinant clotting-factor concentrate brought from home. Beginning in November 1994, the patient's mother administered clotting-factor concentrate to him at home after receiving training from a nurse employed by a home health-care company. Follow-up consisted of an annual visit to a hemophilia treatment center. During February 1995-June 1996, the period during which the child probably became infected, the patient's mother administered factor VIII concentrate to him on 13 occasions. She reported that, until May 1996, three other persons were required to restrain the child during infusions because the child was combative and resistant. Infusions usually were administered through a vein in the foot because of reported difficulties in accessing a vein in the upper arm, and up to 3 hours were required for infusion. The mother recalled that, on at least two occasions, she pricked her finger with the needle while attempting an infusion and drew a visible quantity of blood, but she could not remember whether she continued to use the same needle for the infusion. Before learning in September 1996 that she was infected with HCV, she did not use gloves when infusing clotting-factor concentrate. No other family members assisted in administering factor concentrates.

The child and the mother shared a bed. Although each household member had his or her own toothbrush, bath towels were shared. All household members were negative for or denied recent histories of dermatitis, open wounds, injury, or external bleeding episodes. Sequence analysis of the HCV strains of the child and the HCV-infected family members indicated that the strain isolated from the mother and the child were identical in a sequence of 220 nucleotides in the NS5b region of the genome. Viral sequences in this region isolated from the aunt and brother differed by four and 10 nucleotides, respectively, from the child's strain.

Reported by: L Finelli, PhD, Acting State Epidemiologist, EA Gursky, ScD, Senior Assistant Commissioner, New Jersey Dept of Health and Senior Svcs. Hematologic Diseases Br, Div of AIDS, STD, and TB Laboratory Research, and Hepatitis Br, Div of Viral and Rickettsial Diseases, National Center for Infectious Diseases, CDC.

Editorial Note

Editorial Note: The results of the investigation described in this report suggest that the child acquired HCV infection through percutaneous exposure to the mother's HCV-infected blood during infusion of clotting-factor concentrate. The mother was responsible for infusing factor concentrate and reported incurring needlesticks during some of these infusions. Therefore, blood-to-blood contact may have resulted either from use of a contaminated needle to administer an infusion or by contamination of the infusion site. In addition, analysis of the sequences of the segments of HCV strains isolated from the mother and child indicated the strains were closely related. Because the time of initial infection of the mother could not be documented, the possibility that the child acquired infection from another unrecognized source and was the subsequent source of infection for the mother cannot be excluded. However, the mother had been a long-term injecting-drug user before birth of the child and may have acquired HCV infection through sharing needles and syringes. Surveys indicate that up to 90% of long-term injecting-drug users test positive for anti-HCV (1).

Among persons with hemophilia who were heavily infused with clotting-factor concentrates before the development of viral inactivation methods, the prevalence of anti-HCV exceeds 90% (1). The safety of plasma-derived clotting-factor concentrates has been improved by instituting measures that include screening for serologic markers of bloodborne pathogens in donated plasma used in the manufacture of these products and the incorporation of viral inactivation steps (e.g., dry heating, pasteurization, and solvent detergent treatment) (2). Transmission of HCV or other viral agents has not been reported in association with receipt of genetically engineered factor concentrates or of albumin, the only human plasma-derived material present in these recombinant products (3,4). Based on these considerations, clotting-factor concentrate was an unlikely source of infection in the case described in this report because the child had received only recombinant product during the period in which infection was likely to have been acquired.

Home infusion therapy is a convenient and cost-effective alternative to treatment of hemophilia in the health-care setting (5). However, if proper infection-control procedures are not followed, patients and household members may be at risk for exposure to bloodborne pathogens during home infusion therapy. In one study, 18% of household members who assisted HIV-infected hemophilia patients with the infusion process reported having sustained at least one needlestick injury (6), and HIV infection has been acquired through percutaneous exposure during home treatment of acquired immunodeficiency syndrome (7) and hemophilia (8).

CDC recommends that patients and families who are eligible for home infusion therapy be informed of the potential risks for infection with bloodborne pathogens and be assessed for their ability to use adequate infection-control practices consistently. Patients and families should receive training with a standardized curriculum that includes appropriate infection-control procedures before initiation of home infusion therapy, and infection-control practices should be regularly evaluated at home through follow-up visits by health-care professionals with specific training in such practices. Routine testing of caregivers for bloodborne pathogens is not recommended; all caregivers should follow the universal precautions recommended for all persons who infuse blood products. Gloves should be worn by persons who prepare or infuse blood products and during disposal of infusion equipment and waste. A needle that has broken the skin should not be reused, and used needles should never be recapped. Used needles should be placed in a sharps container in a location inaccessible to children. Needlestick incidents occurring during home infusion therapy should be reported to the health-care professionals supervising home treatment. All household and sexual contacts of patients with chronic hepatitis B virus infection should receive hepatitis B vaccine.

References

  1. Alter MJ. Epidemiology of hepatitis C in the West. Semin Liv Dis 1995;15:5-14.

  2. Kasper CK, Lusher JM, Transfusion Practices Committee. Recent evolution of clotting factor concentrates for hemophilia A and B. Transfusion 1993;33:422-34.

  3. Bray GL, Gomperts ED, Courter S, et al. A multicenter study of recombinant factor VIII (Recombinate): safety, efficacy, and inhibitor risk in previously untreated patients with hemophilia A. Blood 1994;83:2428-35.

  4. Lawrence J. Recombinate: viral safety and final product manufacturing testing and specifications. Ann Hematol 1994;68(suppl 3):S21-S24.

  5. Smith PS, Levine PH. The benefits of comprehensive care of hemophilia: a five-year study of outcomes. Am J Public Health 1984;74:616-7.

  6. Lobato MN, Oxtoby MJ, Augustyniak L, Caldwell MB, Wiley SD, Simonds RJ. Infection control practices in the home: a survey of households of HIV-infected persons with hemophilia. Infect Control Hosp Epidemiol 1996;17:721-5.

  7. CDC. Human immunodeficiency virus transmission in household settings -- United States. MMWR 1994;43:347,353-6.

  8. CDC. HIV infection in two brothers receiving intravenous therapy for hemophilia. MMWR 1992;41:228-31.




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