Piazza M, Sagliocca L, Tosone G, Guadagnino V, Stazi M A, Orlando R, Borgia G, Rosa D, Abrignani S, Palumbo F, Manzin A, Clementi M
Institute of Infectious Diseases, Medical School, University "Federico II," Naples, Italy.
AIDS Patient Care STDS. 1998 Aug;12(8):611-8. doi: 10.1089/apc.1998.12.611.
The sexual transmission of hepatitis C virus (HCV) has long been debated. The prevalence of infected at-risk partners varies from 0% to 30%. In a prospective study, the risk of infection was quantified in steady heterosexual partners and the prophylactic effect of normal human polyvalent immune serum globulin (ISG) was evaluated. A total of 899 at-risk partners of HCV-infected patients were enrolled in a single-blind randomized controlled trial and assigned to receive every 2 month 4 mL of intramuscular ISG from unscreened donors (450 partners) or placebo (499 partners). Seven partners developed acute HCV infection (increased aminotransferase levels and appearance of HCV-RNA): six of the placebo group (incidence density [ID] 12.00/1,000 person year; 95% confidence interval [CI] 3.0 to 21.61), and only one of the ISG-treated group (ID 1.98/1,000 person year; 95% CI 0 to 5.86). The risk of infection was significantly higher in controls versus treated individuals (p = 0.03). Six couples had genotype 1b (85%), and one couple had genotype 1a; HCV sequence homology strongly supported sexual transmission. Our trial demonstrates that HCV infection can be sexually transmitted and quantifies the risk of sexual transmission: for every year of at-risk sexual relationship, almost 1% of the partners became infected. Intramuscular ISG is safe and well tolerated. Unlike ISG from screened donors, ISG from donors unscreened for anti-HCV contains high titers of anti-gpE1/gpE2 neutralizing antibodies and high neutralizing activity. Anti-HCV hyperimmune globulin could be prepared from anti-HCV-positive blood units and could be used to protect sexual partners and in other at-risk situations of exposure to HCV infection.
丙型肝炎病毒（HCV）的性传播一直存在争议。感染风险伴侣的患病率从0%到30%不等。在一项前瞻性研究中，对稳定的异性恋伴侣的感染风险进行了量化，并评估了正常人多价免疫血清球蛋白（ISG）的预防效果。共有899名HCV感染患者的风险伴侣参加了一项单盲随机对照试验，被分配每2个月接受4毫升来自未经筛查供体的肌肉注射ISG（450名伴侣）或安慰剂（499名伴侣）。7名伴侣发生了急性HCV感染（转氨酶水平升高和出现HCV-RNA）：安慰剂组6名（发病密度[ID]为12.00/1000人年；95%置信区间[CI]为3.0至21.61），而ISG治疗组仅1名（ID为1.98/1000人年；95%CI为0至5.86）。对照组的感染风险显著高于治疗组（p = 0.03）。6对夫妇感染的是1b型（85%），1对夫妇感染的是1a型；HCV序列同源性有力地支持了性传播。我们的试验表明，HCV感染可通过性传播，并量化了性传播风险：对于每年处于感染风险的性关系，近1%的伴侣会被感染。肌肉注射ISG安全且耐受性良好。与来自经筛查供体的ISG不同，来自未筛查抗HCV供体的ISG含有高滴度的抗gpE1/gpE2中和抗体和高中和活性。抗HCV高效免疫球蛋白可从抗HCV阳性血液单位制备，并可用于保护性伴侣以及其他有感染HCV风险的情况。
