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
Whitney R. SteeleRoger Y. DoddEdward P. NotariJames M. HaynesSteven A. AndersonAlan WilliamsRita ReikDebra KesslerBrian CusterSusan L. Stramer
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Abstract Background In December 2015, the men who have sex with men (MSM) deferral was reduced to 12 months in the United States. We compared human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) incidence and residual risk before and after this policy change using data from >50% of the US blood supply. Study Design and Methods Three estimation intervals from the Transfusion‐Transmissible Infections Monitoring System were compared: 15‐months pre‐ and two consecutive, nonoverlapping 15‐month post‐MSM deferral implementation. Repeat, first‐time, and weighted all‐donor incidences were estimated. Residual risk was calculated for all incidence estimates using the incidence/window‐period method. Results HIV repeat donor incidence was 1.57 per 100 000 person‐years (phtpy) in the second 15‐month post change and not significantly different from pre‐MSM incidence of 2.19 phtpy. Similar values were seen for HCV (1.49 phtpy vs 1.46 phtpy) and HBV (1.14 phtpy vs 0.97 phtpy). In some cases, higher estimated incidence, but without significant change from pre‐MSM to the second post change period occurred for males and first‐time donors (eg, first‐time donors, second post change period: 6.12 phtpy HIV, 6.41 phtpy HCV and 5.34 phtpy HBV). Estimated per donation residual risk was 1:1.6 million for HIV, 1:2.0 million for HCV and 1:1.0 million for HBV based on weighted incidence for all donors. Conclusions Repeat, first‐time, and overall donor incidence did not vary significantly comparing pre‐MSM to either of the post‐MSM estimation intervals. Residual risk estimates vary by study, but all yield residual risks in the United States of ≤1 per million, and thus far have not shown increasing risk with the 12‐month MSM policy change.Keywords:
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Over the past two decades, a long series of specific and non-specific measures have been introduced into the screening of blood donations in order to reduce the residual risk of transmission of bloodborne viruses. The latest specific measure has been viral nucleic acid testing (NAT), introduced by the European plasma industry in 1995, and subsequently introduced for blood donations in several countries in Europe and elsewhere. NAT was implemented to reinforce the safety of the blood supply; it can detect acute viral infections during the ‘window period’, that were not being detected by the serological screening methods used at that time. To assess the impact of NAT on the safety of the blood supply, it is essential to estimate the residual risk of viral transmission. In this issue, six European countries (France, Germany, Italy, Spain, Switzerland and the United Kingdom) that have recently implemented NAT describe their experiences and the results of the evaluation of the residual risk of viral transmission in their blood supply [1-6].
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Reevaluation of the deferral from voluntary blood donation by men who have sex with men (MSM) is being discussed in several countries, motivated by the need to ensure a blood supply free from transfusion-transmissible infections (e.g., HIV, syphilis). Policies being considered include: permanent exclusion for any male-male sexual encounter, temporary deferral (3 months, 12 months, 5 years) from the last encounter, or specifying behaviors that differentiate MSM at high risk from those at low risk. Current Brazilian regulations defer MSM from blood donation for 12-months after the last male-male sexual encounter. Broad epidemiological evidence indicates that many MSM are at increased risk for HIV in the present era, and few data exist to distinguish which men are likely to be in the immunological window for detection of these infections. A multicenter study developed in Brazil demonstrated that the history of male-male sex was the most strongly associated with being an HIV-positive blood donor. Meanwhile, the blanket deferral of MSM from blood donation has generated considerable controversy. Rejection of the deferral policies stems in part from perspectives defending human rights, promoting equality and citizenship, and alleging bias and discrimination. The objective of this report is to discuss the current situation of blood donation among MSM in Brazil. We highlight the lack of evidence for a true risk profile for male-male sex in the context of blood donation upon which to base sound policy. We recommend research to establish effective and acceptable criteria for blood donation by MSM and other blood donors.
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Blood donation deferral for men who have sex with men (MSM) in France was reduced from permanent to 12 months in July 2016. To inform a further reduction of the deferral period, an HIV risk assessment was conducted with two scenarios: S1, 4-month deferral; S2, 4-month deferral only in the case of more than one sexual partner (i.e., similar to other blood donors).Baseline HIV residual risk (RR) was calculated from July 2016 to December 2017, using the Incidence Rate-Window Period method. The impact of both scenarios on RR was assessed using data from surveys on MSM and blood donors, to estimate 1) the number of additional MSM expected to donate in each scenario and 2) HIV incidence among these donors.Baseline HIV RR was estimated at 1 in 6,380,000 donations. For S1, an additional 733 MSM donors, and an additional 0.09 HIV-positive donations were estimated, yielding an unchanged RR of 1 in 6,300,000. For S2, these numbers were estimated at 3102 and 3.92, respectively, yielding an RR of 1 in 4,300,000. Sensitivity analyses showed that, under worst-case assumptions, the RR would equal 1 in 6,225,000 donations for S1 and 1 in 3,000,000 for S2.For both scenarios, the HIV RR remains very low. For S1, the risk is identical to the baseline RR. For S2, it is 1.5 times higher, and sensitivity analysis shows that this estimate is less robust than for S1. The French Minister of Health announced that S1 will be implemented in April 2020.
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BACKGROUND : This study was designed to assess the risk of transmitting HCV and HIV by transfusion of antibody‐screened blood and to estimate the additional reduction in risk that may be achieved through the implementation of direct viral detection assays in Italy. STUDY DESIGN AND METHODS : Clinical and laboratory data of 2,411,800 blood donations collected from repeat volunteer donors from 1996 through 2000 were analyzed. The risk of transmitting HCV or HIV from screened blood donated during the window period was estimated using a mathematical model. RESULTS : The residual risk of donating antibody‐ negative infectious blood was estimated at 1 in 127,000 donations for HCV and 1 in 435,000 for HIV. The use of NAT should further reduce such risk by 83 percent for HCV and 50 percent for HIV. CONCLUSION : The residual risk of HCV or HIV transmission through screened blood is currently very small in Italy. The implementation of direct viral detection assays can further improve the safety of blood supply.
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Studies have shown that human immunodeficiency virus (HIV) residual risk is higher in Brazilian than in US and European blood donors, probably due to failure to defer at-risk individuals in Brazil. This study assessed the impact of an educational brochure in enhancing blood donors' knowledge about screening test window phase and reducing at-risk individuals from donating.This trial compared an educational intervention with a blood center's usual practice. The brochure was distributed in alternating months to all donors. After donating, sampled participants completed two questions about their HIV window period knowledge. The impact on HIV risk deferral, leaving without donation, confidential unit exclusion (CUE) use, and test positivity was also analyzed.From August to November 2007 we evaluated 33,940 donations in the main collection center of Fundação Pró-Sangue/Hemocentro de São Paulo in São Paulo, Brazil. A significant (p < 0.001) pamphlet effect was found on correct responses to both questions assessing HIV window phase knowledge (68.1% vs. 52.9%) and transfusion risk (91.1% vs. 87.2%). After adjusting for sex and age, the pamphlet effect was strongest for people with more than 8 years of education. There was no significant pamphlet effect on HIV risk deferral rate, leaving without donation, use of CUE, or infectious disease rates.While the educational pamphlet increased window period knowledge, contrary to expectations this information alone was not enough to make donors self-defer or acknowledge their behavioral risk.
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Abstract Background In Canada, the deferral for men who have sex with men (MSM) has been progressively reduced from a permanent deferral for MSM since 1977, to 5 years, 1 year, and, most recently, 3 months. We estimated human immunodeficiency virus (HIV) residual risk and compliance with the MSM time deferral after each change. Methods Four anonymous online compliance surveys were carried out before and after each change. HIV incidence and prevalence were monitored from 2010 to 2021. Residual risk was estimated using the incidence‐window period model. Results Human immunodeficiency virus prevalence, incidence, and residual risk did not change with incrementally shorter MSM deferrals. The residual risk per million donations post 3‐month deferral was 0.05 (0.001–0.371). Men with temporally remote MSM history became eligible and, therefore, compliant as the deferral periods decreased (Cochran‐Armitage p value = <.0001). However, the percentage of men with MSM history in the last 3 months with the indefinite deferral in place was similar to the percentage noncompliant, while the 3‐month deferral was in place. MSM donors did not report high‐risk behaviors for which they would otherwise be deferred in any survey. Following the change, an estimated 4467 MSM per year were eligible to donate, an increase from 2501 estimated eligible MSM donors following the change to the 1‐year deferral. Conclusion With progressively shorter MSM deferral periods, HIV residual risk was unchanged. The proportion of male donors with deferrable MSM history remained low, while those with temporally remote MSM history became eligible, increasing the number of eligible MSM donors.
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A retrospective study of blood donor records was undertaken to obtain risk estimates for transfusing HIV‐contaminated blood due to an infectious window period in a large blood bank in the south of Brazil in the 1990s. An incidence/window period model was used to estimate HIV incidence and risk of seroconversion among 11 286 repeat donors with 8917 person‐years of follow‐up. Separate estimates were calculated for the periods of 1991–94, 1995–96 and 1997–99. Although the residual risk of HIV‐positive transfusion decreased from 1 : 5000 in 1991–94 and 1 : 3794 in 1995–96 to 1 : 48 777 in 1997–99, this is still almost 10 times higher than in developed countries. The risk reduction is likely to have resulted from improved donor selection. Despite a 10‐fold reduction in the risk of transfusing HIV‐contaminated blood because of the screening test's failure to detect the virus during the infectious window period in the 1990s, additional measures are urgently needed to reduce the risk further. To this end, PCR screening of pooled blood donations might be considered in areas of high HIV prevalence when justified by cost‐effectiveness calculations.
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