Sexual transmission of the hepatitis C virus and efficacy of prophylaxis with intramuscular immune serum globulin

A randomized controlled trial

Marcello Piazza, Luciano Sagliocca, Grazia Tosone, Vincenzo Guadagnino, Maria Antonietta Stazi, Raffaale Orlando, Guglielmo Borgia, Domenico Rosa, Sergio Abrignani, Filippo Palumbo, Aldo Manzin, Massimo Clementi

Research output: Contribution to journalArticle

111 Citations (Scopus)

Abstract

Objectives: 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, 3.021.61) 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 tire 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.

Original languageEnglish
Pages (from-to)1537-1544
Number of pages8
JournalArchives of Internal Medicine
Volume157
Issue number14
Publication statusPublished - Jul 28 1997

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Serum Globulins
Hepacivirus
Immunoglobulins
Immune Sera
Randomized Controlled Trials
Hepatitis C Antibodies
Tissue Donors
Hepatitis C
Neutralizing Antibodies
Confidence Intervals
Control Groups
Heterosexuality
Incidence
Virus Diseases
Sequence Homology
Transaminases
Glycoproteins
Enzyme-Linked Immunosorbent Assay
Placebos
Infection

ASJC Scopus subject areas

  • Internal Medicine

Cite this

Sexual transmission of the hepatitis C virus and efficacy of prophylaxis with intramuscular immune serum globulin : A randomized controlled trial. / Piazza, Marcello; Sagliocca, Luciano; Tosone, Grazia; Guadagnino, Vincenzo; Stazi, Maria Antonietta; Orlando, Raffaale; Borgia, Guglielmo; Rosa, Domenico; Abrignani, Sergio; Palumbo, Filippo; Manzin, Aldo; Clementi, Massimo.

In: Archives of Internal Medicine, Vol. 157, No. 14, 28.07.1997, p. 1537-1544.

Research output: Contribution to journalArticle

Piazza, M, Sagliocca, L, Tosone, G, Guadagnino, V, Stazi, MA, Orlando, R, Borgia, G, Rosa, D, Abrignani, S, Palumbo, F, Manzin, A & Clementi, M 1997, 'Sexual transmission of the hepatitis C virus and efficacy of prophylaxis with intramuscular immune serum globulin: A randomized controlled trial', Archives of Internal Medicine, vol. 157, no. 14, pp. 1537-1544.
Piazza, Marcello ; Sagliocca, Luciano ; Tosone, Grazia ; Guadagnino, Vincenzo ; Stazi, Maria Antonietta ; Orlando, Raffaale ; Borgia, Guglielmo ; Rosa, Domenico ; Abrignani, Sergio ; Palumbo, Filippo ; Manzin, Aldo ; Clementi, Massimo. / Sexual transmission of the hepatitis C virus and efficacy of prophylaxis with intramuscular immune serum globulin : A randomized controlled trial. In: Archives of Internal Medicine. 1997 ; Vol. 157, No. 14. pp. 1537-1544.
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abstract = "Objectives: 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, 3.021.61) 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 tire 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.",
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AU - Guadagnino, Vincenzo

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AU - Orlando, Raffaale

AU - Borgia, Guglielmo

AU - Rosa, Domenico

AU - Abrignani, Sergio

AU - Palumbo, Filippo

AU - Manzin, Aldo

AU - Clementi, Massimo

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