We performed a prospective study in a cohort of repeat To assess the incidence and source of community-acblood donors to estimate the risk of acquiring HCV infection quired hepatitis C virus (HCV) infection among subjects among individuals without parenteral exposure, and to invesat low risk for blood-borne diseases, we prospectively tigate the possible cause of infection. studied a cohort of 16,515 repeat blood donors over a mean follow-up time of 36 months. Second-and third-PATIENTS AND METHODS generation methods were used for hepatitis C virus antibody (anti-HCV) testing. HCV RNA was determined in A cohort of 18,109 anti-HCV-negative blood donors, candidates the serum of anti-HCV-positive donors by reverse-tran-for a second or subsequent donation, was enrolled between May 1991 scription polymerase chain reaction. Liver biopsy was and April 1992 in a longitudinal prospective study. Of this cohort, 16,515 subjects came to our center for further donations and were performed in the viremic subjects. Risk factors for HCV followed up for an average of 36 months (range, 3-52 months). The infection were identified by a psychosocial questionmedian interval between donations was 202 days. The male/female naire in the whole cohort. During follow-up, 5 donors ratio was 7:3, the median age was 32 years (range, 18-65 years). A became infected with HCV. The incidence was 1 per psychosocial questionnaire, based on 47 direct and indirect ques-10,000 person-years (95% confidence interval, 0.3-2.4 per tions, was routinely administered to blood donors. 16 Questions re-10,000). During the 6 months before seroconversion, four garded: 1) demographic information; 2) cigarette smoking and alcohol subjects (80%) underwent medical or surgical percutane-consumption; 3) drug use, with reference to type, frequency, and time ous procedures, compared with 26.5% in the entire donor of last assumption; 4) sexual history; 5) history of hepatitis; and 6) cohort (difference between frequencies, 53.5%; CI: 18.9-other risk factors for blood-borne infection (blood transfusion, tattooing, nosocomial exposure). At each donation, the clinical data The subjects showing confirmed anti-HCV reactivity were asked after seroconversion, and liver biopsy showed chronic to enter a follow-up program consisting of clinical and laboratory hepatitis in all cases. Thus, new cases of hepatitis C oc-evaluation, including HCV-RNA determination, at 1-to 3-month incur among individuals without a history of known risk tervals. A serum sample, collected on the blood donation preceding factors, some of which may be caused by nosocomial seroconversion, was retested for anti-HCV using a third-generation exposure. (HEPATOLOGY 1997;25:702-704.) test and was evaluated for HCV RNA. Liver biopsy was proposed to the viremic subjects. Sexual partners and household contacts of seroconverting subjects were invited for counseling and anti-HCV Chronic hepatitis C virus (HCV) infection represents a sig-testing. nificant cause of morbidity and mortality worldwide. 89.1). One seroconverti...
The clinical significance of single band reactivity (indeterminate pattern) at anti-hepatitis C virus (HCV) second-generation recombinant immunoblot assay (RIBA-2) was investigated in symptomless subjects with normal liver function tests to obtain data for their counseling and clinical management. Serum and hepatic HCV RNA were determined by the nested polymerase chain reaction, and liver histology was evaluated in 40 symptomless blood donors with stable indeterminate RIBA-2 pattern, including 38 reactive to c22-3. All but one had normal alanine aminotransferase (ALT) levels. Two new immunoblot tests, RIBA-3 and INNO-LIA HCV Ab III (LIA-III), which incorporate additional HCV antigens, were also done to assess whether they could identify the viremic subjects. Ten cases (25%, confidence interval 12 to 38) were HCV RNA positive. Three of the HCV RNA-positive and none of the HCV RNA-negative subjects had chronic hepatitis. RIBA-2 strong intensity of reaction (score > 2+) was observed in all the HCV RNA-positive and in 12 HCV RNA-negative subjects. RIBA-3 and LIA-III gave positive results in 9 of 10 and 10 of 10 HCV RNA-positive, but also in 8 of 30 and 24 of 30 HCV RNA-negative subjects. A c-22-3 reactivity score of 4+ by RIBA-3 and E2/NS1 reactivity by LIA-III were both strongly associated with HCV RNA (P < .001). Based on relatively high prevalence of chronic hepatitis in our series (30%), apparently healthy subjects with stable indeterminate RIBA-2 pattern and HCV RNA positivity should be considered for liver biopsy independently of ALT profile.(ABSTRACT TRUNCATED AT 250 WORDS)
Although the risk of transfusion-transmitted hepatitis has been recently reduced, transfusion-dependent β-thalassemia patients may still develop liver disease due to viral infection or iron overload. We assessed the frequency and causes of liver dysfunction in a cohort of anti–hepatitis C virus (HCV) negative thalassemics. Of 1,481 thalassemics enrolled in 31 centers, 219 (14.8%) tested anti-HCV− by second-generation assays; 181 completed a 3-year follow-up program consisting of alanine-aminotransferase (ALT) measurement at each transfusion and anti-HCV determination by third-generation enzyme-immunoassay (EIA-3) at the end of study. Serum ferritin levels were determined at baseline and at the end of follow-up. Ten patients were anti-HCV+ by EIA-3 at the end of follow-up. Of them, seven were already positive in 1992 to 1993 when the initial sera were retested by EIA-3, one tested indeterminate by confirmatory assay, and two had true seroconversion (incidence, 4.27/1,000 person years; risk of infection, 1/7,100 blood units, 95% confidence interval [CI], 1 in 2,000-1 in 71,000 units). At baseline, 67 of 174 thalassemics had abnormal ALT. Of those with normal ALT, seven subsequently developed at least one episode of moderate ALT increase (incidence, 24.6/1,000 person-years). All of the 20 patients with ferritin values ≥3,000 ng/mL had clinically relevant ALT abnormalities, as compared with 53 of 151 with <3,000 ng/mL (P< .005). Hepatic dysfunction is still frequent in thalassemics. Although it is mainly attributable to siderosis and primary HCV infection, the role of undiscovered transmissible agents cannot be excluded. © 1998 by The American Society of Hematology.
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