No abstract

BACKGROUND: Thrombotic events (TEs) are rare but often serious adverse events that could occur after administration of immune globulin (IG) products. Our study objective was to assess occurrence of recorded TEs after administration of different US‐licensed IG products and investigate potential risk factors using a large administrative database. STUDY DESIGN AND METHODS: This is a retrospective claims‐based cohort study of individuals exposed to IG products from January 1, 2008, through September 30, 2010, using HealthCore's Integrated Research Database, a longitudinal health care database. IG products were identified by recorded Healthcare Common Procedure Coding System codes. TEs were ascertained via International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes. Logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for same‐day TEs by IG product, while controlling for confounders. RESULTS: Of 11,785 individuals exposed to IG products in the study period, 122 (1%) had TE(s) recorded on the same day as IG administration. TE rates per 1000 persons exposed ranged from 6.1 to 20.5 for different IG product groups. Vivaglobin users had an increased same‐day TE risk compared to reference Gammagard Liquid users (OR, 3.56; 95% CI, 1.54‐8.23). An increased TE risk was also found with older age (≥45 years), prior TE(s), and hypercoagulable state(s). CONCLUSION: The study suggests potentially elevated TE rates for different IG products, including subcutaneous. It also identifies important recipient TE risk factors and suggests that risk–benefit profiles should be weighed before IG administration. The observed differences may be due to various factors such as dosage, administration rates, and product manufacturing processes that warrant further evaluation.

No abstract

No abstract

BACKGROUND: Implementation of sensitive screening methods for human immunodeficiency virus (HIV) and hepatitis viruses prompts the question of what quantitative risks may result from altered deferral strategies for donation of blood by men who have had sex with men (MSM). STUDY DESIGN AND METHODS: Quantitative probabilistic models were developed to assess changes in the residual risk of transfusion-transmitted HIV and hepatitis B virus (HBV) associated with blood testing and quarantine release errors (QREs) in the initial year of two hypothetical policy scenarios that would allow donations from donors who have abstained from MSM behavior for at least 5 years (MSM5) or at least 1 year (MSM1). RESULTS: The MSM5 and MSM1 models, respectively, predicted annual increases in units of HIV-infected blood of 0.5% (0.03 mean additional units; 95% confidence interval [CI], 0-1) and 3.0% (0.18 mean additional units; 95% CI, 0-1) over current estimated HIV residual risk using recent, nationwide biologic product deviation reports to estimate QRE rates. These estimates are approximately 10-fold lower than estimates based on New York State QRE data from the previous decade. The models predicted smaller increases in infectious HBV donations. CONCLUSIONS: QREs remain the most significant preventable source of risk. More accurate inputs, including the percentage of MSM in the population, the percentage of MSM who have abstained from MSM activity for 1 or 5 years, the prevalence of HIV and HBV in MSM who have abstained from MSM activity for 1 or 5 years, the rate of self-deferral, and QRE rates, are required before making more precise predictions. ABBREVIATIONS: ARC = American Red Cross; BPDR = Biological Product Deviation Reports; FNE(s) = falsenegative error(s); HHV = human herpesvirus; MSM = men who have had sex with other men; MSM1 = donors who have abstained from MSM behavior for at least 1 year; MSM5 = donors who have abstained from MSM behavior for at least 5 years; QRE(s) = quarantine release error(s); TTI(s) = transfusion-transmitted infection(s). 1102 TRANSFUSION Volume 49, June 2009B lood donor screening practices recommended by the Food and Drug Administration (FDA) defer individuals with a history of behavior associated with an increased risk of certain infectious diseases. This policy is a part of a multitiered approach to blood safety, which includes donor screening and deferral based on geographic, behavioral, and medical risk factors; laboratory testing and deferral; registries to prevent use of blood from deferred donors; quarantine controls to prevent donation release pending verification of donor suitability; and investigation and correction of deviations. The development of multiple, highly sensitive tests for certain transfusion-transmissible viruses that have a high prevalence in men who have had sex with other men (MSM) raises questions concerning the effectiveness of deferring MSM from blood donation.Research has shown that the prevalence of infectious disease agents, including human immunodeficiency virus (...

Context: Antiretroviral therapy (ART) to treat and pre-exposure prophylaxis (PrEP) to prevent HIV infection are effective tools to help end the HIV epidemic. However, their use could affect HIV transfusion-transmission risk. Objectives: Three different ART/PrEP prevalence analyses in blood donors were conducted. Methods: First, blood samples from HIV-positive and a comparison group of infection-nonreactive donors were tested under blind using liquid chromatography-tandem mass spectrometry for ART. Second, blood donor samples from infection-nonreactive, 18-45 year-old, male, first-time blood donors in six US locations were tested for emtricitabine and tenofovir. Third, in men who have sex with men (MSM) participating in the 2017 CDC National HIV Behavioral Surveillance (NHBS) from five US cities self-reported PrEP use proximate to donation was assessed. Findings: In blind testing, no ART was detected in 300 infection-nonreactive donor samples, but in 299 HIV-confirmed infected donor samples, 46 (15.4%, 95% CI 11.5 - 20.0%) had evidence of ART. Of the 1,494 samples tested from first-time, male donors, 9 (0.6%, 95% CI 0.03 - 1.1%) had tenofovir and emtricitabine. In the NHBS MSM survey, 27 of 591 respondents (4.8%, 95% CI 3.2 - 6.9%) reported donating blood in 2016 or 2017 and PrEP use within the same time frame as blood donation. Conclusions: Persons who are HIV-positive and taking ART and persons taking PrEP to prevent HIV infection are donating blood. Both situations could lead to increased risk of HIV transfusion transmission if blood screening assays are unable to detect HIV in donations from infected donors.

No abstract

Our study identified largest number of potential TACO cases to date and showed a substantial increase in TACO occurrence with age and number of units transfused. The study suggested increased TACO risk in elderly with congestive heart failure, chronic pulmonary disease and anaemias. Overall, study shows importance of large administrative databases as an additional epidemiological tool.