AbstractAs part of a multi-year surveillance program of tick-borne diseases, we describe babesia surveillance of blood donors using nucleic acid tests conducted in 2025 and summarize cases of babesiosis reported by public health officials in Nova Scotia, Canada, from 2023 through 2025. Among 10,976 blood donor specimens, one specimen, collected from a blood donor in Nova Scotia Health's Western Zone, was positive, although this result was unable to be confirmed. Since babesiosis became reportable in Nova Scotia on May 23, 2023, eleven clinical cases have been documented, including eight in individuals who resided in the Western Zone and had no recent history of travel.

BACKGROUND AND OBJECTIVES:Chagas disease (Trypanosoma cruzi), prevalent in Mexico, Central and South America, can be transfusion-transmitted. Selective serological testing of blood donors was implemented over 15 years ago. We describe the trends in infections and characteristics of donors selected for testing. MATERIALS AND METHODS:Donor selection for testing was based on birth in Latin America and/or mother/grandmother born in Latin America and/or travel to Latin America (30 days duration at Héma-Québec [HQ], 6 months at Canadian Blood Services [CBS]). All first-time donors (2010-2024) were analysed. Frequencies were compiled by gender, age group, region and residential material deprivation and ethnocultural composition indices. Multiple logistic regression compared donors with risk factors (tested) versus those without risk factors (not tested). RESULTS:Of the 67,490 tested donors, most were born in Mexico, Central or South America (71% at CBS). Of the 27 donors positive for T. cruzi antibodies, more were from Ontario, materially deprived and ethnocultural concentrated neighbourhoods. One had mother/grandmother birth, but none had travel as the sole risk factor. Tested donors were similar to non-tested donors except more likely to be aged 30-49 (odds ratio [OR] 1.4, 1.37-1.44 CBS, 1.57, 1.51-1.63 HQ) and live in more ethnoculturally concentrated neighbourhoods (OR 2.09, 2.01-2.18 CBS, 3.46, 3.29-3.64 HQ). CONCLUSION:Birth in Latin America captures most T. cruzi antibody positive donations. Mother/grandmother risk occasionally yields a positive donation, but travel history does not. Infections in donors are rare, but selective testing interdicts a small risk of T. cruzi positive blood products being released into inventory.

BACKGROUND:One mitigation strategy for donor iron deficiency is to implement ferritin testing and encourage donors with low ferritin to pause donation and increase iron intake. We evaluated positive outcomes (reduced hemoglobin deferrals) and negative outcomes (donor nonreturn) in a 2-year observation period after implementing ferritin testing of female donors at each 10th donation. METHODS:Donors with ferritin below 25 ug/L were advised to pause donation for 6 months and see their health care practitioner about increasing iron intake but were not deferred. Ferritin results for donors screened in the first 6 months of the program (Jan-June 2023), hemoglobin on return and time to return in the 2 years following testing were calculated for low ferritin and normal/high ferritin donors. RESULTS:Twenty five percent of 8613 tested donors had low ferritin, associated with younger age, high donation frequency, and previous hemoglobin deferral. About one third of low ferritin donors returned to donate less than 6 months after testing, and had a hemoglobin deferral rate of 16%, compared to 4.4% in those who waited 6 months or more and 5.2% in donors with normal ferritin. After 2 years, 77.5% of low ferritin compared to 88.5% of normal/high ferritin donors returned to donate. CONCLUSION:Iron deficiency was common. Low ferritin donors who paused donation and returned to donate had hemoglobin deferral rates similar to normal ferritin donors. However, many returned early and had high failure rates. Two years after testing, an 11% difference in return rates remained between low and normal/high ferritin donors.

BACKGROUND:In 2022, Canadian Blood Services implemented a gender-neutral sexual behavior-based screening (SBBS) approach to donor deferral, replacing time-based criteria targeting gay, bisexual and other men who have sex with men (gbMSM) and female partners of gbMSM. We assessed the impact of this policy change on human immunodeficiency virus (HIV), hepatitis C (HCV), and hepatitis B (HBV) prevalence, incidence, and residual risk. STUDY DESIGN AND METHODS:We compared prevalence rates among first-time donors, incidence rates, and residual risk for allogeneic donations made in the 3 years pre-SBBS implementation and 3 years post-SBBS implementation. RESULTS:HIV and HBV prevalence remained steady while HCV prevalence increased among first-time donors post SBSS-implementation. Point estimates for incidence rates and residual risks decreased for each marker post-implementation, but differences were not significant. Residual risks post-implementation were 1 in 34.7 million for HIV, 1 in 64.1 million for HCV, and 1 in 3.1 million for HBV. DISCUSSION:Residual risks of infection remain low following the implementation of a gender-neutral sexual risk behavior-based approach to donor deferral. This policy change has not negatively impacted the safety of the Canadian blood supply.

BACKGROUND:Many blood centers now accept donors with diabetes, provided their condition is "well-controlled". However, glycemic control is not routinely assessed at donation, and the impact of donor diabetes on blood product quality remains unclear. STUDY DESIGN AND METHODS:To screen glycemic control, glycated hemoglobin A1c (HbA1c) was measured in whole blood from 256 unique donors with either type 1 diabetes (T1D), type 2 diabetes (T2D), or without known diabetes. In parallel, routine quality control (QC) data were linked with donor metadata to assess the impact of donor diabetes on red cell concentrate (RCC) and apheresis platelet concentrate (PC) quality at the time of their expiry. RESULTS:Nearly half of donors with diabetes had suboptimal glycemic control (HbA1c >7 %) at donation, including 57.1 % of donors with T1D and 43.4 % with T2D. RCC units from donors with T2D (n = 1,329) had higher hemolysis (p <.001) and a greater proportion exceeding the clinical threshold of 0.8 % hemolysis (p <.001). These differences were not observed with T1D (n = 46). Apheresis PC units from donors with T2D (n = 164) had lower expiry pH (p = .014), with a trend toward more units below the clinical cutoff of pH 6.4 (p = .059). Differences in both products were most pronounced in donors with T2D using both metformin and insulin. CONCLUSION:Many donors with diabetes have suboptimal glycemic control, and RCC and PC from donors with T2D have reduced quality. The observed effects are modest, likely not driven by glycemic control alone, and do not support additional deferral criteria for donors with diabetes.

BACKGROUND AND OBJECTIVES:Canadian Blood Services implemented a re-entry programme in 2014. Donors deferred because of false-reactive or indeterminate screening tests can provide a specimen for re-entry testing 6 months after their initial test, and resume donating if they test negative for all infectious markers. We evaluated the impact of the programme on donor return and retention, and assessed factors associated with reactive results upon re-entry testing. MATERIALS AND METHODS:Using extracted data from our donor database, we followed up donors who tested false-reactive for hepatitis B virus (HBV), human immunodeficiency virus (HIV) and hepatitis C virus (HCV), from the implementation of the programme on 3 February 2014 until 30 June 2025 (n = 8094). We characterized the donors reaching each step of the programme by sex, age, donation status and infection marker. We employed logistic regression to identify important predictors of obtaining reactive results upon re-entry testing. RESULTS:Overall, 17.3% of donors eligible for re-entry testing successfully returned and donated. Re-entry testing participation rates were 35.5%, with repeat and older donors more likely to participate. Among re-entry tested donors, 59.2% tested negative. Most donors continued to donate for multiple years upon re-entry. Upon return, 13.1% tested false reactive on a subsequent donation. False-reactives upon re-entry testing were more likely for first-time donors and less likely when a different assay was employed than for the initially false-reactive. CONCLUSION:The implementation of a donor re-entry programme has resulted in donor retention and increases in the blood supply. Sending reminder notifications to eligible donors could increase participation.

Background Babesia is a parasite transmitted by the Ixodes tick and has the potential to be transfusion transmitted. Climate change and changing Ixodes tick distributions in Canada raised questions about the impact of Babesia on the blood supply. Following a risk-based decision making (RBDM) process, Canadian Blood Services initiated a multi-year Babesia nucleic acid test (NAT) surveillance program in 2024. The first year of the project focused on a region (Manitoba, Canada) previously determined by the RBDM analysis to be of highest risk for Babesia NAT-positive donations. The aim of this study is to provide an update on this multi-year surveillance project that will shape our understanding of Babesia epidemiology in multiple Canadian provinces.Study Design and Methods From July 11, 2024 to November 9, 2024, samples were collected in Roche Whole Blood Collection tubes at all whole blood donation sites in Manitoba. Specimens underwent one-time individual testing on the cobas Babesia NAT on the Roche cobas 6800 platform (Roche Diagnostics GmbH, Mannheim, Germany). Clinical cases of babesiosis were reviewed for the period 2013-2025.Results Of the 13,608 (98%) whole blood donations tested by Babesia NAT, none were positive. Clinical case rates of babesiosis in Manitoba ranged from 0 to 0.13 per 100,000 population annually.Discussion Changing climate and Ixodes tick distributions have led to concerns that the epidemiology of Babesia infection in Canadian blood donors is increasing. Babesia NAT on specimens from an elevated-risk area for Babesia infection in Canada did not identify Babesia-positive blood donors.

BACKGROUND AND OBJECTIVES:Selective immunoglobulin A (IgA) deficiency is the most common human immunodeficiency, affecting approximately 1 in 500-800 individuals of European ancestry. It is defined by a serum IgA level below 7 mg/dL, with normal immunoglobulin G (IgG) and immunoglobulin M (IgM) levels. Since 1968, severe allergic transfusion reactions have been reported in IgA-deficient patients, often linked to anti-IgA antibodies. This led to recommendations for using IgA-deficient blood components in affected individuals. However, due to the rarity of such reactions, standardized and evidence-based guidelines are lacking, while blood services face logistical challenges maintaining registries of IgA-deficient donors and inventories of compatible products. MATERIALS AND METHODS:An international survey was conducted to assess current practices in managing IgA deficiency. The survey explored the frequency of transfusion reactions involving IgA/anti-IgA, detection methods for IgA deficiency and anti-IgA antibodies, reasons for requesting IgA-deficient products, product availability and strategies to facilitate access to IgA-deficient products. RESULTS:Participants from 14 countries/regions across four continents reported a wide variability in defining IgA deficiency, criteria for recommending IgA-deficient products and anti-IgA testing practices. CONCLUSION:These findings highlight the need for international reference standards and harmonized recommendations to improve the management of IgA-deficient patients. Establishing harmonized best practices and evidence-based guidelines should enhance patient safety and support clinical decision making globally.

Frequent blood donation can deplete iron stores, increasing the risk of iron deficiency anemia. Postdonation iron supplements may help preserve donor health, but willingness to take supplements likely depends on donor knowledge and confidence. We conducted a cross-sectional survey among 5691 whole blood donors from 6 countries (Netherlands, USA, Japan, Finland, Sweden, Germany). Knowledge was assessed using 16 true-or-false statements on 4 blood donation-related topics; confidence by asking if donors were "certain" or "guessing." Willingness to take supplements was assessed using 3 scenarios: to continue donating, when advised by a donor physician, and general iron supplementation rejection. Using logistic regressions, we assessed associations between knowledge, confidence, and willingness to take iron supplements for each scenario, adjusted for sex, age, country, prior supplement use, and trust in the blood service. Most donors exhibited medium to high knowledge and under confidence in that knowledge. Willingness to take supplements was high (80.6%-84.2% across scenarios). Knowledge and confidence were not consistently associated with willingness to take supplements. In contrast, trust in the blood service (odds ratio [OR] = 1.64, P < .001) and prior supplement use (OR = 1.87, P < .001) were strongly associated with willingness when supplements were required to continue donating, with similar effects across other scenarios. Willingness varied across countries, with higher willingness in Nordic countries. These findings suggest that trust-building approaches may be more promising than education-focused strategies, though causal relationships require further research. High acceptance rates suggest that postdonation iron supplementation may be a feasible strategy for donor iron management.

BACKGROUND AND OBJECTIVES:Seasonal vaccinations reduce donor illness and appointment cancellations and ensure plasma products have antibodies to vaccine-directed strains. We aimed to describe donor influenza and COVID-19 vaccination history and compare this with the general population. MATERIALS AND METHODS:Two online donor surveys were carried out in 2021 and 2024. Donors were asked about demographics, influenza (2019/2020, 2020/2021 and 2023/2024 seasons) and COVID-19 (ever and 2023/2024 season) vaccination and reasons for vaccination choices. General population vaccination statistics were extracted from public reports. Percentages of donors receiving vaccination were calculated with 95% confidence intervals. Multiple logistic regression models were fitted with demographics as independent variables. RESULTS:In survey 1, 4582 (30.4% response rate) donors completed a questionnaire; in survey 2, 6376 (21% response rate). More donors under age 65 received the influenza vaccine compared with the general population under age 65 (58% vs. 30% in 2019/2020, 63% vs. 28% in 2023/2024, p < 0.0001) and aged 65+ (81% vs. 70% in 2019/2020, 90% vs. 73% in 2023/2024, p < 0.0001). Fewer donors and the general population received the COVID-19 vaccine in 2023/2024 (under 65 45% vs. 39%; 65+ 76% vs. 67%, p < 0.0001). Most said they were vaccinated to prevent infection and protect others. CONCLUSION:Seasonal vaccination rates are higher in older donors, consistent with public health recommendations. Blood donors are more likely to be vaccinated against seasonal influenza than the general population, but post-pandemic uptake of the COVID-19 booster vaccine was low, more similar to the general population.

BACKGROUND AND OBJECTIVES:Concern over variant Creutzfeldt-Jakob disease (vCJD) led to the deferral of donors who had resided in the United Kingdom since January 1980. This deferral was implemented in 1999 and subsequently modified to include other countries. Some deferrals were removed in February 2022; deferrals for the United Kingdom, Ireland and France were removed on 22 November 2023. In this study, we describe efforts made to encourage donation from newly eligible people and the resulting donation gain. MATERIALS AND METHODS:Actions targeted individual donors deferred after 1 January 2012. Marketing included website, social media and general advertising. Staff asked first-time donors if the criteria change had motivated their donation. Deferred and returning donor data were determined from our donor database. RESULTS:In the 12 months post-implementation, 12.8% of first-time donors surveyed were newly eligible (n = 8667) and 7.8% of vCJD risk deferred donors returned (n = 5159). Eighty-five percent of deferrals occurred pre-2017; the return rate was 6.5% in this group. The highest return rate (24%) occurred in donors deferred after 2020. CONCLUSION:Removal of the vCJD deferrals had a major positive impact. The greatest gain was in new donors who had previously self-deferred. Despite intensive efforts, only one-quarter of recently deferred donors returned.

BACKGROUND:The Donor Health Assessment Questionnaire (DHQ) is fundamental to blood safety. We describe attitudes towards truthfulness among first-time donors who tested positive for transfusion transmissible infections and those who did not. METHODS AND MATERIALS:From 2005 to 2022 donors positive for infectious markers (cases) and demographically matched controls rated their agreement with statements about truthfulness, privacy and the value of the DHQ. RESULTS:There were 798 (32% participation) cases and 3192 (39% participation) controls. Most said they read questions carefully (93% cases, 96% controls, p < 0.01) and answered truthfully (95% cases, 99% controls p < 0.01). Fewer thought the questions make the blood safer (79% cases, 80% controls, p = 0.39) and some agreed it is OK not to answer questions truthfully if you know your blood is safe (21% cases, 16% controls, p < 0.01). Privacy to answer personal questions was generally adequate (88% cases, 91% controls, p < 0.01). Attitudes were similar regardless of paper or electronic DHQ format. CONCLUSION:Most first time donors believe they answer screening questions truthfully, but some question the safety benefit to recipients and judge whether they need to be truthful. This was true for donors with positive infectious markers as well as their matched infection-negative controls.

In the United States and other high-income countries, blood donation primarily relies on anonymous, voluntary donors. However, directed blood donation-where people donate for a specific recipient-has resurged, particularly due to misinformation surrounding COVID-19 vaccination. Requests for "nonvaccinated" blood, driven by misconceptions about vaccine safety, have led to legislative attempts to mandate compliance. Historically, directed donation was used to mitigate the risk for transfusion-related infections before modern screening techniques rendered it largely unnecessary. Today, it presents important patient safety risks, including increased infectious disease transmission, immunologic complications, and logistic burdens. Directed donations also introduce inefficiencies, diverting resources from the community blood supply and exacerbating shortages. Moreover, directed donation for nonmedical indications lacks scientific justification. Blood safety is ensured through rigorous donor screening, pathogen testing, and processing measures. There is no evidence that blood from vaccinated donors poses risk. Requests for nonvaccinated blood, as well as other directed donation preferences based on personal beliefs, introduce biases that are not grounded in medical necessity. Accommodating such requests undermines public trust in blood safety protocols and legitimizes unfounded fears. Ethical concerns arise as non-medically justified requests reinforce discriminatory practices, such as selecting donors based on race or gender. Allowing such preferences risks politicizing blood donation, spreading misinformation, and straining health care systems. Although autonomy is a core ethical principle in medicine, it does not justify non-evidence-based interventions. Given the potential harm and societal impact, directed blood donations should be limited to rare, medically necessary cases. Ongoing legislative efforts to mandate these requests require unified opposition from the medical and scientific community to uphold ethical, evidence-based, blood allocation practices.

BACKGROUND AND OBJECTIVES:Early in the COVID-19 pandemic, blood suppliers faced unique challenges meeting changing demand while maintaining safety for donors, recipients and staff. Actions taken may have altered the composition of the donor base and the frequency of confirmed-positive infectious disease marker (IDM) rates. No studies have evaluated the impact of the pandemic on donations, donor demographics and blood safety across several countries. MATERIALS AND METHODS:Whole blood/red blood cell (RBC) donors and donations and confirmed IDM reactivity recorded during from 11 March 2019 to 11 September 2019 ("pre-pandemic period") and from 11 March 2020 to 11 September 2020 ("pandemic period") were collected by 11 blood services participating in the Biomedical Excellence for Safer Transfusion (BEST) Collaborative. RESULTS:Eleven blood services from nine countries reported on over 4 million donations per period. On average, donations dropped by 4.0% between pre-pandemic and pandemic periods, driven by fewer donations from active repeat donors (-5.6%) and first-time [FT] donors (-14.0%) but partially offset by more donations from lapsed donors (+15.7%). The decline was also driven by fewer donations from male donors (-7.6%) and younger donors (i.e., 16-25 years: -19.0%). Overall, the rate of confirmed IDM positivity dropped from 100.0 to 88.6 per 100,000 donors (-11.4%) between pre-pandemic and pandemic periods. CONCLUSION:Early in the pandemic, blood donations, particularly from FT donors, decreased. In future respiratory virus pandemics, blood banks should anticipate changes in demand, collection site locations and capacity and donor behaviour. Unlike results in acute catastrophes, lower rates of confirmed IDM positivity were observed, in part related to lower numbers of FT, male and younger donors.

INTRODUCTION:Donors are deferred if they are on antiretroviral medications (ARV) as post-exposure or pre-exposure prophylaxis (PEP or PrEP) for human immunodeficiency virus (HIV). We assessed donor compliance by measuring ARV levels in selected anonymized donor samples collected from September 22, 2022 to December 31, 2024, almost all after the introduction of sexual risk behavior screening. METHODS:EDTA plasma samples collected at the time of donation (retention samples) were retrieved, frozen, and shipped for measurement of tenofovir and emtricitabine. Samples were from randomly selected first-time male donors in large urban areas (n = 520), syphilis (n = 133), or HIV (n = 6) confirmed positive donors, and donors deferred for PEP or PrEP use on a previous donation attempt who returned to successfully donate (n = 225 tests, 115 unique donors). We compare our results to international studies. RESULTS:All samples from first-time male donors, HIV-positive donors, syphilis-positive female donors, and female donors previously deferred for PEP or PrEP were negative. Three of 110 male syphilis-positive donors (2.7%) and 14 of 85 male donors previously deferred for PEP or PrEP (16.5%) were positive for ARV. Eleven of these donors were tested multiple times, and 10 were positive more than once. CONCLUSION:Results on syphilis-positive male donors were similar to findings in England and the Netherlands. Noncompliance with criteria for ARV use was high in male donors previously deferred for PEP/PrEP. Messaging regarding recipient risk is particularly difficult in this group, since it is at odds with the reduction in individual HIV risk.

BACKGROUND:In September 2022, Canadian Blood Services replaced the time-based deferral for gay and bisexual men who have sex with men (gbMSM) with sexual behavior-based questions. All donors who had sex with a new partner or >1 partner in the last 3 months and anal sex were deferred, permitting gbMSM with one regular partner to donate. We aimed to measure compliance with the new criteria post-implementation. STUDY DESIGN AND METHODS:Pre-implementation 42,999; post-implementation 41,157 donors were invited to complete an anonymous online sexual risks survey. Results were weighted reflecting the donor base age, sex, and geography base. Frequencies and 95% confidence intervals were calculated. RESULTS:In total, 13,159 donors participated pre-implementation (33% participation, 6532 females and 6627 males of whom 183 had ever had sex with another man (gbMSM)); post-implementation 11,217 donors (28% participation, 5253 females and 5964 males of whom 188 were gbMSM). Pre-implementation 9.3% (4.3%-14.2%) gbMSM had a new or >1 partner and anal sex in the last 3 months (all ineligible), similar to post-implementation when some were eligible (8.9%, 4.1%-13.8%, p > .05). There was no difference between pre- and post-implementation for non-gbMSM males (pre- 0.7%, 0.5%-1.0% vs. post-0.7%, 0.4-0.9) and females (pre- 0.8%, 0.6%-1.0% vs. post-0.6%, 0.4-0.8%) (p > .05). The estimated non-compliance of those with deferrable behavior was 87% (79%-93%). Most donors reported being comfortable with the new questions. DISCUSSION:The majority of donors with deferrable sexual behaviors failed to disclose post-implementation. Donors may make a judgment about whether they need to disclose behaviors in screening.

Background and ObjectivesDespite screening procedures, a few blood donors confirm positive for transfusion-transmissible infections and are deferred. Effective notification of laboratory results is essential to ensure that donors are advised of confirmed results and to seek medical care. Here we report results from post-notification interviews of Canadian Blood Services donors.Materials and MethodsOver 17 years, 2006-2022, all donors with confirmed positive results for hepatitis B virus (HBV), hepatitis C virus (HCV), human T-cell lymphotropic virus (HTLV) and syphilis were notified by registered mail of their result and advised to see a physician. In a separate communication, all donors were later invited to participate in a scripted interview asking whether they tested positive for an infection; if yes, which one, what their reaction was, whether they consulted a physician and whether public health contacted them. Frequencies of responses were calculated.ResultsOf 2654 donors with confirmed positive test results, 876 (33%) participated; 90% said they were informed of a positive test result. Of these, about a quarter did not know for which infection they were positive. Most were surprised, and some were sad or disappointed. Most saw a physician after notification (77%). About two-thirds with HBV or HCV said they were contacted by public health, slightly fewer (58%) with syphilis, 27% of those with HTLV.ConclusionMost donors recalled being notified and were aware of their positive test, but details of the infection were sometimes not understood or recalled, and not all donors consulted a physician about the infection.

Medication use is extremely common in blood donors. Blood centers use various methods to obtain a history of medication use, all of which have strengths and weaknesses. Some data are available to develop policies for medications that impact product quality, transmissible disease testing, and infectious risks. Many blood centers defer donors for use of a small number of highly teratogenic medications, as a precautionary measure. Others also defer for possible harms related to the pharmacologic effects of medications. However, a single exposure to a blood component containing medication, with immediate dilution in the recipient's blood stream, is a very different situation from ongoing use of medication in a patient, with steady state concentrations achieved over time. It is therefore highly unlikely that these effects are relevant for recipient safety.

BACKGROUND AND OBJECTIVES:Until recently, gay, bisexual and other men who have sex with men (MSM) were deferred from donating blood for 3-12 months since the last male-to-male sexual contact. This MSM deferral has been discontinued by several high-income countries (HIC) that now perform gender-neutral donor selection.MATERIALS AND METHODS:An international symposium (held on 20-04-2023) gathered experts from seven HICs to (1) discuss how this paradigm shift might affect the mitigation strategies for transfusion-transmitted infections and (2) address the challenges related to gender-neutral donor selection.RESULTS:Most countries employed a similar approach for implementing a gender-neutral donor selection policy: key stakeholders were consulted; the transition was bridged by time-limited deferrals; donor compliance was monitored; and questions or remarks on anal sex and the number and/or type of sexual partners were often added. Many countries have now adopted a gender-neutral approach in which questions on pre- and post-exposure prophylaxis for human immunodeficiency virus (HIV) have been added (or retained, when already in place). Other countries used mitigation strategies, such as plasma quarantine or pathogen reduction technologies for plasma and/or platelets.CONCLUSION:The experience with gender-neutral donor selection has been largely positive among the countries covered herein and seems to be acceptable to stakeholders, donors and staff. The post-implementation surveillance data collected so far appear reassuring with regards to safety, although longer observation periods are necessary. The putative risks associated with HIV antiretrovirals should be further investigated.