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Retrovirus Epidemiology Donor Study-II (REDS II) Molecular Surveillance (MS) - (REDS_II_MS_BioLINCC)

Data Access NOTE: Please refer to the "Authorized Access" section below for information about how access to the data from this accession differs from many other dbGaP accessions.

Protocol Synopsis: We propose to conduct a genetic analysis of incident and prevalent strains of HIV, HCV and HBV by testing blood specimens from HIV, HCV or HBV positive blood donors who give blood at REDS-II, UBS, BCP, NYBC and ARC blood centers between 2006 and 2008. The frequency of the different genetic lineages of these viruses will be evaluated and compared between incident (recently acquired) and prevalent (more remotely acquired) infections. We will also evaluate if genotypic distributions vary by demographic characteristics and by geographical area. Informative viral genetic regions will be PCR amplified, sequenced and phylogenetically analyzed to determine genotypes and subtypes. Anti-viral drug and antibody neutralization resistance mutations will also be recorded. This study will provide an oversight of the genetic diversity of blood borne agents detected in the US using current NAT, antigen and serological assays. Using published data, this analysis of viruses in blood donors will allow us to also determine whether this population is infected with the same strains of viruses as seen in more at-risk populations. Genetic characterization of viruses in NAT-yield and recent seroconverting donations, which represent incident cases, will allow for characterization of circulating strains of viruses thus enabling early detection of rare variants and longitudinal tracking of changes in genotype frequency of actively transmitted strains. Because genetic variants of HIV, HCV and HBV appear to differ in properties such as pathogenicity, anti-viral therapy response and antibody neutralization properties, the genetic characterization of incident strains will also guide future anti-viral and vaccine research in the US.

Objectives

The objective of the study was to conduct a genetic analysis of incident and prevalent strains of HIV, HCV and HBV by testing blood specimens from HIV, HCV or HBV positive blood donors who gave blood at REDS-II centers, as well as at UBS, NYBC and ARC blood centers between 2006 and 2009.

Background

Genetic variations of human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) can affect diagnostic assays and therapeutic interventions. Recent changes in prevalence of subtypes/genotypes and drug/immune-escape variants were characterized by comparing recently infected vs. more remotely infected blood donors.

Participants

This study included qualifying donations from 1 January 2006 through 31 December 31 2009 from 3 Retrovirus Epidemiology Donor Study-II (REDS-II) blood centers (Blood Centers of the Pacific, Blood Center of Wisconsin, and Hoxworth Blood Center/University of Cincinnati), all American Red Cross Blood Services regions, United Blood Services regions and the New York Blood Center. Together, these centers account for approximately 70% of the US blood supply.

Design

Infected donors were identified among approximately 34 million US blood donations, 2006–2009 based on screening and confirmatory tests for HIV and HCV nucleic acid testing, HIV and HCV antibody, HBsAg, and anti-HBV core antibody; incident infections were defined as having no or low antiviral antibody titers. Viral genomes were partially sequenced.

Conclusions

Viral genetic variant distribution in blood donors was similar to that seen in high-risk US populations. Blood-borne viruses detected through large-scale routine screening of blood donors can complement molecular surveillance studies of highly exposed populations. (Delwart et. al. 2012)