Testing For Hepatitis C Virus Infection Research Articles

Confirmatory Testing for HCV Infection Often Not Performed

Approximately 3 million people in the U.S. are infected with the hepatitis C virus (HCV), a major cause of cirrhosis and hepatic cancer. Although HCV

Performance of Premarket Rapid Hepatitis C Virus Antibody Assays in 4 National Human Immunodeficiency Virus Behavioral Surveillance System Sites

Performance characteristics of rapid assays for hepatitis C virus antibody were evaluated in 4 National HIV Behavioral Surveillance System injection drug use sites. The highest assay-specific sensitivities achieved for the Chembio, MedMira and OraSure tests were 94.0%, 78.9%, and 97.4%, respectively; the highest specificities were 97.7%, 83.3%, and 100%, respectively. The Centers for Disease Control and Prevention (CDC) estimates that 4.1 million Americans have been infected with hepatitis C virus (HCV) and 75%-80% of them are living with chronic HCV infection, many unaware of their infection. Persons who inject drugs (PWID) account for 57.5% of all persons with HCV antibody (anti-HCV) in the United States. Currently no point-of-care tests for HCV infection are approved for use in the United States. Surveys and testing for human immunodeficiency virus (HIV) and anti-HCV were conducted among persons who reported injection drug use in the past 12 months as part of the National HIV Behavioral Surveillance System in 2009. The sensitivity and specificity of point-of-care tests (finger-stick and 2 oral fluid rapid assays) from 3 manufacturers (Chembio, MedMira, and OraSure) were evaluated in field settings in 4 US cities. Sensitivity (78.9%-97.4%) and specificity (80.0%-100.0%) were variable across assays and sites. The highest assay-specific sensitivities achieved for the Chembio, MedMira, and OraSure tests were 94.0%, 78.9% and 97.4%, respectively; the highest specificities were 97.7%, 83.3%, and 100%, respectively. In multivariate analysis, false-negative anti-HCV results were associated with HIV positivity for the Chembio oral assay (adjusted odds ratio, 8.4-9.1; P < .01) in 1 site (New York City). Sensitive rapid anti-HCV assays are appropriate and feasible for high-prevalence, high-risk populations such as PWID, who can be reached through social service settings such as syringe exchange programs and methadone maintenance treatment programs.

Integrating Hepatitis Services into Substance Abuse Treatment Programs: New Initiatives from SAMHSA

Integrating Hepatitis Services into Substance Abuse Treatment Programs: New Initiatives from SAMHSA

The relationship between lichen planus and hepatitis C in dermatology outpatients in Kerman, Iran

Lichen planus (LP) is classified as a papulosquamous disease. It has been associated with liver disease, particularly hepatitis C virus (HCV) infection, in several studies. Most of these reports, especially the larger series, were conducted in Europe and Japan. We conducted a case-control study in Kerman, Iran to explore the association between LP and HCV. The study included 66 patients with LP (as cases; mean age = 39.7 +/- 15.8 years; 31 female, 35 male) and 140 volunteer blood donors (as controls; mean age = 29.5 +/- 8.4 years; 43 females, 97 males). An enzyme-linked immunosorbent assay (ELISA) was used to determine the presence of anti-HCV antibodies in all subjects in both groups. To confirm positive diagnoses, a second generation recombinant immunoblot assay (RIBA II) test was performed. Lichen planus lesions were most frequently located on the trunk and extremities, and the most common clinical type was generalized LP (48.5%). One of the patients with LP (1.5%) and three of the controls (2.1%) were HCV-Ab positive. No significant difference was observed in HCV-Ab positive between the two groups (OR = 0.7; 95% CI = 0.1-6.9). The findings indicate that an investigation for HCV infection should not necessarily be performed in all patients with LP. It is recommended that further studies should focus on larger groups in other regions of Iran to determine whether testing for HCV infection is necessary in patients with LP.

Prevention of spread of hepatitis C

Hepatitis C virus (HCV) is transmitted by percutaneous or permucosal exposure to infectious blood or blood-derived body fluids. Based on the results of cohort and acute case control studies, risk factors associated with acquiring HCV infection in the United States have included transfusion of blood and blood products and transplantation of solid organs from infected donors, injecting drug use, occupational exposure to blood (primarily contaminated needle sticks), birth to an infected mother, sex with an infected partner, and multiple heterosexual partners. Nosocomial and iatrogenic transmission of HCV primarily are recognized in the context of outbreaks, and primarily have resulted from unsafe injection practices. Transmission from HCV-infected health care workers to patients is rare. Transfusions and transplants have been virtually eliminated as sources for transmission, and most (68%) newly acquired cases of hepatitis C are related to injecting drug use. The primary prevention of illegal drug injecting will eliminate the greatest risk factor for HCV infection in the United States. Other prevention strategies that need to be widely implemented include risk reduction counseling and services and review and improvement of infection control practices in all types of health care settings. Testing for HCV infection should be routinely performed for persons at high risk for infection or who require postexposure management. There are no recommendations for routine restriction of professional activities for HCV-infected health care workers, and persons should not be excluded from work, school, play, and child care or other settings on the basis of their HCV infection status. (Hepatology 2002;36:S93-S98).

Prevention of spread of hepatitis C.

Hepatitis C virus (HCV) is transmitted by percutaneous or permucosal exposure to infectious blood or blood-derived body fluids. Based on the results of cohort and acute case control studies, risk factors associated with acquiring HCV infection in the United States have included transfusion of blood and blood products and transplantation of solid organs from infected donors, injecting drug use, occupational exposure to blood (primarily contaminated needle sticks), birth to an infected mother, sex with an infected partner, and multiple heterosexual partners. Nosocomial and iatrogenic transmission of HCV primarily are recognized in the context of outbreaks, and primarily have resulted from unsafe injection practices. Transmission from HCV-infected health care workers to patients is rare. Transfusions and transplants have been virtually eliminated as sources for transmission, and most (68%) newly acquired cases of hepatitis C are related to injecting drug use. The primary prevention of illegal drug injecting will eliminate the greatest risk factor for HCV infection in the United States. Other prevention strategies that need to be widely implemented include risk reduction counseling and services and review and improvement of infection control practices in all types of health care settings. Testing for HCV infection should be routinely performed for persons at high risk for infection or who require postexposure management. There are no recommendations for routine restriction of professional activities for HCV-infected health care workers, and persons should not be excluded from work, school, play, and child care or other settings on the basis of their HCV infection status.

Cryoglobulinemia in systemic lupus erythematosus: Prevalence and clinical characteristics in a series of 122 patients

Objectives: To determine the prevalence and nature of cryoglobulins in 122 patients with systemic lupus erythematosus (SLE) and identify the clinical and immunologic features related to their presence. Methods: In a cross-sectional study, we investigated 122 consecutive patients (106 women and 16 men) with SLE who fulfilled the 1982 revised criteria of the American College of Rheumatology for the classification of SLE. All patients had documented medical histories and underwent a medical interview as well as a routine general physical examination by a qualified internist, and their clinical and serologic characteristics were collected on a protocol form. Serum samples were obtained at 37°C, and cryoglobulinemia was estimated by centrifugation at 4°C after incubation for 7 days in all patients. The type of cryoglobulinemia was identified by agarose gel electrophoresis and immunofixation. Results: Cryoglobulins were detected in the sera of 31 SLE patients (25%): 20 patients (65%) had a cryocrit lower than 1%, 8 (26%) had percentages ranging between 1% and 5%, and only 3 patients (9%) had a cryocrit over 5%. Only cutaneous vasculitis (39% v 16%; P =.01) was more prevalent in patients with than in those without cryoglobulins. Rheumatoid factor (RF) (42% v 15%; P =.002) and low CH50 levels (84% v 49%; P <.001) were more prevalent in SLE patients with cryoglobulins. Hepatitis C virus (HCV) infection was investigated in 24 of the 31 cryoglobulinemic SLE patients and was detected in 5 (21%). In comparison, 4 (5%) of the 75 noncryoglobulinemic SLE patients studied were positive (P = 0.035; odds ratio, 4.67). Patients with a cryocrit greater than 1% showed a higher frequency of HCV infection than those with a cryocrit less than or equal to 1% (46% v 0%, P =.01). Conclusions: Cutaneous vasculitis, RF, hypocomplementemia, and HCV infection were associated with cryoglobulins in SLE patients. Testing for HCV infection is therefore recommended for patients with SLE and cryoglobulinemia to identify this subset of patients for prognostic and therapeutic reasons. Semin Arthritis Rheum 30:363-373. Copyright © 2001 by W.B. Saunders Company

Sjögren's syndrome and hepatitis C virus.

Sjögren's Syndrome (SS) is an autoimmune disease that mainly affects exocrine glands and usually presents as a persistent dryness of the mouth and eyes. The spectrum of the disease extends from an organ-specific autoimmune disease to a systemic process. Viral infection has long been suspected as a potential cause of SS because several viruses have been incriminated in the aetiology of this disease, and a possible relationship between SS and hepatitis C virus (HCV) was postulated in 1992. In this paper, we review the literature concerning SS and HCV infection and summarise the current knowledge regarding their association and their pathogenic, clinical and immunological significances. The main conclusions of this review are that the prevalence of antibodies to HCV in patients with primary SS ranges between 14 and 19% using third-generation ELISA, chronic HCV infection may mimic the main clinical, histological and immunologic features of 'primary' SS and, finally, testing for HCV infection must be performed in patients with SS, especially in those patients with evidence of liver involvement or associated cryoglobulinaemia. HCV seems to be a rare cause of 'primary' SS in the absence of recognised liver disease or cryoglobulinaemia.

Prophylaxis of Hepatitis C with Intramuscular Immunoglobulin

Hepatitis C virus (HCV) affects millions of individuals worldwide. In most cases, HCV infection progresses to chronic liver disease and, subsequently, to liver cirrhosis and hepatocellular carcinoma. HCV is transmitted by the parenteral route, for example by transfusion of blood or blood products, injection during drug abuse, etc., and by the inapparent parenteral route (penetration of the virus through difficult-to-identify microlesions present on the skin or mucosae), for example, sexual exposure or household exposure to infected contacts, etc. The cost of chronic hepatitis C and its sequelae is high in both financial and human terms. At present, only anti-HCV screening of blood/organ/tissue donors and universal precautions for the prevention of blood-borne infections are recommended for HCV prevention. Before the discovery of the main aetiological agent of non-A, non-B hepatitis (HCV), several randomised controlled clinical trials demonstrated that standard intramuscular immunoglobulin exerted a preventive effect on post-transfusional and sexual and /or horizontal transmission of non-A, non-B hepatitis. When serological tests for HCV infection became available, bimonthly inoculation of standard unscreened intramuscular immunoglobulin (prepared from plasma pools containing about 2% of anti-HCV-positive units) was demonstrated to significantly prevent sexually transmitted HCV infection. The immunoglobulin used contained high titres of anti-HCV neutralising antibodies (anti-E2 neutralisation of binding assay), whereas currently available commercial screened immunoglobulin (prepared from anti-HCV-negative blood units) did not. This finding suggested that anti-HCV neutralising antibodies are concentrated only in anti-HCV-positive units (which are currently discarded). Thus, anti-HCV hyperimmune globulin (HCIg) can be produced only from anti-HCV-positive units. The neutralising titre can be increased by the exclusive use of units with higher titres of neutralising antibodies. Unlike other hyperimmune globulins, which are produced from a limited number of selected donors, HCIg should be produced from a large number of units so as to contain neutralising antibodies to the different HCV strains. HCIg will have a number of advantages: (i) it is easy to produce and inexpensive; (ii) it has a long half-life, allowing infrequent administration; (iii) new additional viral inactivation procedures have been introduced to eradicate transmission of infection, and (iv) it may be possible to neutralise all the emerging HCV strains. HCIg could be used in all individuals at risk of HCV infection (sexual partners, haemodialysis patients, etc), in preventing reinfection of transplanted livers, and perhaps also in the treatment of chronic hepatitis C, alone or associated with other drugs.

Cryoglobulinemia in primary Sjögren's syndrome: Prevalence and clinical characteristics in a series of 115 patients

Objectives: To determine the prevalence and nature of cryoglobulins in a large series of patients with primary Sjögren's syndrome (SS) and identify the clinical and immunologic features related to their presence. Methods: In a cross-sectional study, we investigated 115 consecutive patients(107 women and eight men) with primary SS. All patients fulfilled four or more of the preliminary diagnostic criteria for SS proposed by the European Community Study Group in 1993. Serum cryoglobulinemia was measured in all patients. Serum samples were obtained at 37°C, and cryoglobulinemia was estimated by centrifugation after incubation at 4°C for 7 days. The type of cryoglobulinemia was identified by agarose gel electrophoresis and immunofixation. Results: Cryoglobulins were detected in the sera of 18 (16%) of our patients with primary SS; most were IgMκ monoclonal/IgG polyclonal. When compared with patients without cryoglobulins, those with cryoglobulins presented a higher prevalence of leukocytoclastic cutaneous vasculitis (56% v 8%, P < .001), hypocomplementemia (75% v 2%; P < 0.001) and antibodies to hepatitis C virus (HCV) (47% v 8%, P < .001). Liver involvement (clinical signs, biochemical features, or ultrasound/histological data of liver disease) was present in all patients (100%) with cryoglobulins and HCV infection but in only 11% of patients with cryoglobulins without HCV infection ( P < .001). Conclusions: Leukocytoclastic cutaneous vasculitis, hypocomplementemia,and HCV infection are associated with the presence of cryoglobulins in the sera of patients with primary SS. Testing for HCV infection is recommended for patients with SS and cryoglobulinemia because of its high prevalence and its strong association with liver disease.

Sexual Transmission of the Hepatitis C Virus and Efficacy of Prophylaxis With Intramuscular Immune Serum Globulin

To estimate the risk of sexual transmission of hepatitis C and to assess the value of prophylaxis with periodic intramuscular immune serum globulin administration. 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. 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. 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.

Improved detection of antibodies to hepatitis C virus by the second-generation assay in patients with chronic non-A, non-B liver disease

Serum samples from 337 Japanese patients with chronic non-A, non-B liver disease were tested for antibodies to hepatitis C virus (HCV) by means of first-generation (c100-3; anti-c100) and second-generation (pHCV-34, pHCV-31, c100-3; anti-HCV II) enzyme linked immunosorbent assays (ELISA) and for antibody to the GOR epitope (anti-GOR) also by ELISA. Anti-HCV II was detected in 314 (93.2%), anti-c100 in 247 (81.3%) and anti-GOR in 211 (62.6%) samples. Thus, anti-HCV II was more sensitive in detecting HCV infection than either anti-c100 or anti-GOR (P < 0.001). All serum samples reactive with anti-c100 or anti-GOR reacted with anti-HCV II. Among 314 anti-HCV II-positive patients, we found that 185 (58.9%) were positive for both anti-c100 and anti-GOR while 14 (4.5%) were positive for anti-HCV II alone. Nine (64.3%) of the 14 are presently infected with HCV, as revealed by detection of HCV RNA in their serum; the remaining five may have been infected in the past with HCV. These findings indicate that HCV is a major causative agent of chronic non-A, non-B liver disease in Japan and that detection of anti-HCV II is a specific and more sensitive diagnostic test for HCV infection.