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

Steele, Whitney R.; Dodd, Roger Y.; Notari, Edward P.; Haynes, James M.; Anderson, Steven A.; Williams, Alan E.; Reik, Rita; Kessler, Debra; Custer, Brian; Stramer, Susan L.; System, Transfusion-Transmissible Infections Monitoring

doi:10.1111/trf.16250

Cited by 36 publications

(40 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Previous reports have indicated a rate of transmission of 2.2% to 100% depending on the component transfused from occult HBV infections in blood donors and such estimates from India are lacking 18 . The RR of transmission of HCV and HIV was lower than that of HBV in our study which is still considerably higher when compared to developed countries (≤1 per million) 14,15 . This risk is however lower when compared to neighbouring countries from our region such as Pakistan with a similar seroprevalence of these infections 17 …”

Section: Discussioncontrasting

confidence: 64%

“…The estimated RR of transmission of HBV was observed to be relatively higher when compared to that reported from other countries. [13][14][15] This is not surprising considering that India falls in intermediate endemicity zone (prevalence of 2%-7%, average of 4%), with a disease burden of about 50 million. 16 However, RR of HBV transmission in our study is comparable to that of other neighbouring countries with similar epidemiology such as Pakistan where a RR of HBV transmission of 1 in 10 900 donors was observed.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Residual risk estimates of transfusion transmissible hepatitis B, hepatitis C and human immunodeficiency virus using nucleic acid testing yield/window period model in an Indian setting

Pandey

Varghese

Rana

et al. 2022

Transfusion Medicine

View full text Add to dashboard Cite

Background Estimation of residual risk (RR) is necessary to understand status of blood safety with current testing strategies and need to improve it further. These estimates from India are lacking till date. Present study was aimed to estimate RR and incident rate (IR) of transfusion transmitted infectious disease (TTIDs) in Indian setting. Study Design and Methods Blood donor demographic data, serological testing results and nucleic acid testing (NAT) screening results were collected retrospectively from January 2015 to June 2017. Mathematical modelling using NAT yield/window period model was done to estimate IR and RR of TTIDs. Data was compared between different groups based on age‐group, gender, donation repeatability and type of donor. Results A total 106 119 blood donors donated 109 441 units with overall TTID reactivity of 2.22%. HBV was most prevalent TTID (1.26%) with RR of 16.1 per million followed by HCV and HIV with RR of 4.4 and 3.1 per million donations, respectively. NAT testing variably reduced RR ranging from 69.4% to 96.1% depending on TTID. Younger, repeat and voluntary donors had significantly lower prevalence of TTIDs compared to older, first time and replacement donors. Discussion Gaps in the blood safety could be bridged significantly by implementing NAT testing and using quality serological assays. Comparatively high RR despite using quality serological assays and ID‐NAT testing highlights need to develop long term strategies to improve blood safety by focusing on improving donor pool by recruiting regular voluntary donors among youth and imparting knowledge of healthy practices.

show abstract

Section: Discussioncontrasting

confidence: 64%

Section: Discussionmentioning

confidence: 99%

Residual risk estimates of transfusion transmissible hepatitis B, hepatitis C and human immunodeficiency virus using nucleic acid testing yield/window period model in an Indian setting

Pandey

Varghese

Rana

et al. 2022

Transfusion Medicine

View full text Add to dashboard Cite

show abstract

“…Safety can be monitored following changes to men who have sex with men (MSM) deferral criteria by assessing changes in HIV incidence and residual risk and performing compliance surveys. The United States, Australia, the United Kingdom, and France have all published data relating to HIV residual risk estimation following moves to a 12‐month deferral; 8–11 however, not all countries have used compliance surveys to monitor the impact of changing deferral criteria at each stage. Canada was the only country to evaluate compliance prior to changing from an indefinite deferral and progressively following each change from 5‐year, 1‐year, and 3‐month deferrals.…”

Section: Introductionmentioning

confidence: 99%

HIV incidence and compliance with deferral criteria over three progressively shorter time deferrals for men who have sex with men in Canada

et al. 2021

View full text Add to dashboard Cite

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.

show abstract

“…However, since 2014 (32 cases), the number of cases has precipitously dropped to ~17 per year between 2015 to 2016, ~12 per year between 2017 to 2018, 5 in 2019, 1 in 2020, and no case to date in 2021. A decrease in HCV residual risk from 1 per 1 million between 2007 and 2008 to 1 per 2 million between 2018 and 2019 was also noted, whereas 2,3 similar declines have not been observed for HIV or HBV.…”

Section: Introductionmentioning

confidence: 66%

Background rate of low‐level HCV RNA in anti‐HCV confirmed‐positive and minipool nucleic acid test‐nonreactive blood donations

et al. 2021

Self Cite

View full text Add to dashboard Cite

Background In 2019, the Food and Drug Administration revised the requirement for further testing of anti‐HCV‐reactive donations testing nucleic acid (NAT)‐nonreactive via routine mini‐pool (MP)‐NAT. Individual donation (ID)‐HCV NAT was required as a supplemental test prior to a second FDA‐licensed anti‐HCV assay; if ID‐HCV‐NAT is reactive, no further testing is required. This study investigated the rate of low‐level RNA in anti‐HCV‐reactive donation samples prior to and following the implementation of supplemental ID‐HCV NAT. Study Design/Methods A retrospective analysis was conducted on frozen plasma unit samples from 1161 anti‐HCV confirmed‐positive/HCV‐NAT‐nonreactive donations collected from December 2014 to January 2020. Samples were tested by multiple replicates on the Grifols Procleix Ultrio Elite (UE) assay and corresponding discriminatory HCV (dHCV) assay on the Procleix Panther System. Prospectively, the prevalence of low‐level RNA in 2912 anti‐HCV‐reactive donations detected through routine screening from April 2020 through March 2021 was determined. Results In retrospective analyses, 10 (0.86%) of 1161 plasma samples were UE reactive, of which four (0.34%) were dHCV reactive (in all replicates of UE and dHCV). Of 2912 anti‐HCV‐reactive donation samples testing NAT‐nonreactive via routine MP‐NAT, three (0.1%; 95% CI: 0.04‐0.30) were dHCV reactive; 37% of the remaining samples were reactive by a second anti‐HCV assay and thus serologically confirmed. Conclusions Retrospective and prospective analysis in comparison to earlier studies revealed that low‐level HCV‐RNA reactivity is decreasing over time. The very low HCV‐RNA rates may be due to the widespread use of highly effective, direct‐acting anti‐viral treatments for those diagnosed with HCV infection.

show abstract

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

Cited by 36 publications

References 15 publications

Residual risk estimates of transfusion transmissible hepatitis B, hepatitis C and human immunodeficiency virus using nucleic acid testing yield/window period model in an Indian setting

Residual risk estimates of transfusion transmissible hepatitis B, hepatitis C and human immunodeficiency virus using nucleic acid testing yield/window period model in an Indian setting

HIV incidence and compliance with deferral criteria over three progressively shorter time deferrals for men who have sex with men in Canada

Background rate of low‐level HCV RNA in anti‐HCV confirmed‐positive and minipool nucleic acid test‐nonreactive blood donations

Contact Info

Product

Resources

About