Assessment of hepatitis C virus RNA and genotype from 6807 patients with chronic hepatitis C in the United States

Abstract

Hepatitis C virus (HCV) RNA status and HCV genotype have become important tools in the diagnosis and monitoring of therapy in chronic HCV infection. To establish a database with respect to HCV genotype and serum HCV RNA concentrations in chronic hepatitis C patients in the United States, we analysed 6807 chronic hepatitis C patients who had HCV RNA and HCV genotype tests conducted at a central laboratory. The HCV RNA concentration cut-off for the lower 25th percentile of this population (low titre) was 0.9 x 106 copies ml-1. The median HCV RNA concentration was 3.5 x 106 copies ml-1 and the cut-off for the upper 25th percentile (high titre) was 5 x 106 copies ml-1. Male patients had a median HCV RNA concentration of 3.9 x 106 copies ml-1, which was significantly higher than the median HCV RNA level for females (2.75 x 106 copies ml-1; P < 0.001). HCV genotype 1 was detected in 73% of patients; genotype 2 in 14%; genotype 3 in 8%; mixed genotype in 4%; and genotypes 4, 5 and 6 with a frequency of < 1%. Patients from the Northeast, Southeast and Midwest had significantly (P < 0.001) more infections with genotype 1 than patients from the Western and Southern regions. African-American patients were more likely to be infected with genotype 1 when compared with Caucasian, Hispanic or Asian Pacific Islanders (P < 0.001). Patients infected with HCV genotype 1 and mixed HCV genotypes had significantly higher serum HCV RNA concentrations when compared with HCV genotypes 2 and 3 (P < 0.001 for all comparisons).

Analytical Performance Characteristics and Clinical Utility of a Novel Assay for Total Hepatitis C Virus Core Antigen Quantification

“…While the trak-C assay could not detect core antigen in 10 of 90 HCV RNApositive samples obtained from German hemodialysis centers (38), its Architect counterpart correctly recognized all of these specimens with very low levels of HCV viremia. Therefore, use of the Abbott test might provide at least an interim solution for the yet unresolved issue and the still ongoing discussion in the dialysis community of the need for and advantage of supplemental HCV RNA testing of anti-HCV-negative patients on maintenance hemodialysis (3,7,9,16,40). Similar considerations could apply to other settings, including transplantation medicine, in which the availability of a sensitive immunoassay for HCV core antigen determination should also represent a valuable diagnostic benefit for the immediate resolution of peculiar serological constellations which are particularly problematic in the course of decision making (20).…”

Epidemiology and risk factors for hepatitis C in Alaska Natives

“…2 We found a lower prevalence of genotype 1 (62%) and a higher prevalence of genotypes 2 and 3 (38%) compared with a study of 6,807 patients from 10 clinic-based practices in the U.S., 73% and 22%, respectively. 24 Persons infected with HCV genotypes 2 and 3 have a higher success rate with antiviral treatments compared with those with genotype 1. 13,25 Thus, a higher proportion of ANs have a greater likelihood of responding to antiviral therapy.…”

“…In a large U.S. multicenter study, higher levels of HCV RNA also has been found in males compared with females and in persons infected with genotype 1 versus genotypes 2 and 3. 24 Male gender has been shown to be a risk factor for the development of fibrosis 8,28 ; the higher level of HCV RNA found in men could be a factor in this process, yet this remains to be proven.…”

Population Pharmacokinetics and Pharmacodynamics of Ribavirin in Patients with Chronic Hepatitis C Genotype 1 Infection

“…Chronic HCV is a leading cause of liver cirrhosis, end-stage liver disease, and hepatocellular carcinoma (2). Among the six known genotypes of HCV, the highly resistant genotype 1 is dominant (73-75%) in the USA (3,4). Treatment of chronic HCV infection includes weekly pegylated interferon alpha (PEGIFN) combined with weight-based ribavirin administered orally for up to 48 weeks (5).…”