HIV antiretroviral therapy and prevention use in US blood donors: a new blood safety concern

Abstract

<jats:p>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.</jats:p>

HIV, HCV, and HBV incidence and residual risk in US blood donors before and after implementation of the 12‐month deferral policy for men who have sex with men

“…In response, the AABB recommends that donors be asked about PrEP (and other antiretroviral drug use) and be deferred either indefinitely if taking antiretrovirals to treat an HIV infection (as HIV-positive donors have been identified with such drugs in their donation samples), or for 12 weeks if taking PrEP. 16,17 The NAT yield ratio method estimates first-time donor incidence to be approximately four times higher than that of repeat donor incidence for all three viruses. The weighted incidence for all donors is higher than that of repeat donors but does not significantly increase between pre-MSM and post2-MSM time periods.…”

Donor screening question alternatives to men who have sex with men time deferral: Potential impact on donor deferral and discomfort

“…Determining the capacity of these questions to identify and defer high‐risk MSM is difficult because those with recent sexual activity are currently deferred; thus, data are not collected. In addition, risk may be complicated by availability of preexposure prophylactic HIV treatment (PrEP) extending the risk period 12 . The “no more than one partner” criterion used in France was implemented based on presumed risk reduction rather than empirical evidence.…”

Evidence of HIV pre-exposure or post-exposure prophylaxis (PrEP/PEP) among blood donors: a pilot study, England June 2018 to July 2019

“…9 10 Blood transfusion is a more effective means of virus transmission than sexual behaviour; HIV transmission via blood transfusion is possible and has been described in cases of non-detectable viral load. 11 12 With a combination of donor deferral policies together with highly effective serological and molecular screening of blood donations, the risk of not detecting and releasing a potentially infectious HIV donation has been estimated around 0.04/ million donations in the UK (95% CI 0.01 to 0.07) and no transfusion-transmitted HIV infection has been reported in the UK since 2002. 13 14 However, the effects of PrEP on assays used to screen blood donors for HIV are well recognised by international blood transfusion communities.…”