title: Sexual transmission of the hepatitis C virus and efficacy of prophylaxis with intramuscular immune serum globulin. A randomized controlled trial.
abstract: OBJECTIVE
  To estimate the risk of sexual transmission of hepatitis C and to assess the value of prophylaxis with periodic intramuscular immune serum globulin administration.
  
  
  METHODS
  Of 1102 steady heterosexual partners of patients with antibodies to the hepatitis C virus (HCV), 899 were enrolled in a single-blind, randomized, controlled trial. All the partners tested negative for antibodies to HCV and had normal baseline serum aminotransferase concentrations. The partners were assigned to receive 4 mL of 16% polyvalent immune serum globulin prepared from unscreened donors every 2 months (n = 450) or a placebo (n = 449). Tests for HCV infection were performed every 4 months.
  
  
  RESULTS
  Eight hundred eighty-four partners completed the study. Seven partners became infected with HCV: 6 in the control group (incidence density, 12.00 per 1000 person-years; 95% confidence interval, 3.0 21.61) and 1 in the immune serum globulin group (incidence density, 1.98 per 1000 person-years; 95% confidence interval, 0-5.86). The risk of infection was significantly higher for partners in the control group (P = .03): for each year approximately 1% of the partners became infected. Sequence homology studies strongly suggest the sexual transmission of HCV. All immune serum globulin lots used had high enzyme-linked immunosorbent assay titers of neutralizing antibodies to HCV envelope glycoproteins and high neutralization titers in the neutralization of binding assay.
  
  
  CONCLUSIONS
  Hepatitis C can be sexually transmitted. Immune serum globulin prepared from unscreened donors significantly reduced the risk. The treatment was safe and well tolerated. Because only immune serum globulin from unscreened donors (and not from those screened for HCV) contain anti-HCV neutralizing antibodies, hyperimmune anti-HCV immune serum globulin should be prepared from blood testing positive for antibodies to HCV, which is currently discarded.
authors.affiliation: Istituto di Malattie Infettive, Universitá degli Studi di Napoli Federico II, Naples, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Piazza
authors.forename: L
authors.initials: L
authors.lastname: Sagliocca
authors.forename: G
authors.initials: G
authors.lastname: Tosone
authors.forename: V
authors.initials: V
authors.lastname: Guadagnino
authors.forename: M A
authors.initials: MA
authors.lastname: Stazi
authors.forename: R
authors.initials: R
authors.lastname: Orlando
authors.forename: G
authors.initials: G
authors.lastname: Borgia
authors.forename: D
authors.initials: D
authors.lastname: Rosa
authors.forename: S
authors.initials: S
authors.lastname: Abrignani
authors.forename: F
authors.initials: F
authors.lastname: Palumbo
authors.forename: A
authors.initials: A
authors.lastname: Manzin
authors.forename: M
authors.initials: M
authors.lastname: Clementi
mesh_terms: D000328:Adult; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006023:Glycoproteins / Q000276:immunology; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000235:genetics / Q000276:immunology / Q000517:prevention & control* / Q000635:transmission*; D018937:Hepatitis C Antibodies / Q000097:blood; D006801:Humans; D007116:Immunization, Passive; D015994:Incidence; D008297:Male; D008875:Middle Aged; D012306:Risk; D015229:Sexually Transmitted Diseases, Viral / Q000276:immunology / Q000517:prevention & control*; D016037:Single-Blind Method; D016896:Treatment Outcome; D014759:Viral Envelope Proteins / Q000276:immunology
chemical_list: D006023:Glycoproteins; D018937:Hepatitis C Antibodies; D014759:Viral Envelope Proteins