A national hepatitis C elimination program is underway in the country of Georgia. The program employs a multifaceted approach spanning health promotion/awareness, prevention (including harm reduction, infection prevention and control, and blood safety), surveillance, testing and linkage to care, with an objective to eliminate hepatitis C. Hepatitis B vaccination is available for free for beneficiaries of the hepatitis C elimination program and other population groups at high risk of infection. A history of blood transfusion was previously identified as being associated with hepatitis C virus (HCV) infection in Georgia[1, 2]. Furthermore, a high HCV seroprevalence was reported in blood donors[3]. Consequently, global reform of blood transfusion services in Georgia was integrated into the hepatitis C elimination program, with support from the “Safe Blood” State program with an overarching goal to harmonize the national transfusion policies and practices with those of the European Union (EU)[4]. Notable areas of blood transfusion services that have been prioritized in Georgia include its regulatory framework (legislation, development of standards and accreditation), a transition to a nonprofit funding model of blood collection centers, exclusive non-remunerated blood donation, improved laboratory testing, and quality oversight[4-6].

Recruitment of voluntary non-remunerated blood donors (VNRBDs) remains an enduring challenge for many low- and middle-income countries (LMICs)[7]. This is the case in Georgia, an upper-middle income country, where a high proportion of the blood supply is still collected from paid or family replacement blood donors. Family replacement refers to friends or family of the intended transfusion recipient who donate either for that individual specifically or are expected to donate to replenish extant transfusion inventories. By contrast and with rare exception, blood for transfusion in the United States (US) and other high-income countries is collected from VNRBDs. Paid and family replacement donation is discouraged given its established higher risk for the major transfusion-transmissible infections (TTIs) (i.e. human immunodeficiency virus [HIV], hepatitis B virus [HBV], HCV and T. pallidum [syphilis])[8]. Paid and family replacement donation is viewed as being potentially coercive, whereby individuals are less likely to admit any behaviors placing them at higher risk of infection, which could result in their deferral[9]. Deferral could invite scrutiny in the case of family replacement donors or prevent earning for paid donors.

New legislation in Georgia, which was developed by the Ministry of Internally Displaced Persons from the Occupied Territories, Health, Labor and Social Affairs of Georgia in partnership with an EU twinning project (i.e.“strengthening blood safety in Georgia”), mandates exclusive collection of blood from non-remunerated blood donors by July 2025. We sought to determine the prevalence and risk of transmission of HCV and the other major transfusion-transmitted viruses (HBV and HIV) according to remuneration status.

The findings, supported by prior studies[5, 10], indicate a decline in prevalence of infectious markers among blood donors in Georgia since inception of the hepatitis C elimination program in 2015. This is consistent with the observed decrease in prevalence in the general population, again highlighting the impact of the hepatitis C elimination program[5, 11]. The prevalence of marker reactivity remained high among first time paid and replacement donors, and was lowest among first time VNRBDs. However, the prevalence of marker reactivity was uniformly low across all categories of repeat donors, yet still lowest among repeat VNRBDs. The overall prevalence among first time and repeat donors combined was lowest among paid donors, due to the fact that paid donors were more than twice as likely to be repeat donors compared to other remuneration types. The substantially higher donation rate among paid donors has important implications for sustainability of the blood supply, and merits broader consideration as Georgia formalizes goals of exclusive non-remunerated blood donation by 2025[4].

Voluntary blood donation is central to blood transfusion safety, having been established as posing the lowest risk of TTIs[5, 8, 9, 12-14]. However, the transition from paid and replacement donation to an exclusively voluntary donor pool is a formidable undertaking. Ironically, VNRBDs are more expensive than replacement or even paid donation, given the need for the infrastructure and personnel to recruit individuals continuously[15]. The appeal of replacement and paid donors is the ability to mobilize those donors rapidly, including in times of emergency. The World Health Organization (WHO) advocates, exclusively, for VNRBDs in large part given the concerns over higher risk of TTIs in paid and replacement donors. A voluntary donor pool is needed to ensure sufficiency and sustainability of the safe blood supply[16]. Establishment of a voluntary non-remunerated donor pool should remain the overarching goal. However, in the context of low-resourced countries, particularly in Africa, safety of the blood supply may be at odds with sufficiency[16]. A position favoring retention rather than remuneration status is not new, having long been proposed, particularly in sub-Saharan Africa where the number of collections fails to meet clinical demand[17-19]. Acknowledging the inherent flaws of the WHO benchmark of blood sufficiency[20], Georgia well exceeds the minimum threshold of 10 blood donations per 1000 population (i.e. donations in Georgia are ~24–26 per 1000 population of donation age). Nonetheless, the study findings demonstrate that the prevalence of infectious marker positivity was lowest among repeat VNRBDs, and also low among repeat paid donors, yet the donation frequency was almost 2.5-fold higher than VNRBDs. This highlights the importance of donor retention rather than simply remuneration status alone.

Globally, data are lacking in regard to the extent to which paid and replacement donation are undertaken and the associated infectious risk. Limited data suggest that infectious risk for paid, replacement and even voluntary donors may vary by region. . For example, paid donation in Africa has been suggested as being driven by poverty[21]. This is particularly high risk as it incentivizes a cadre of donors who donate excessively[16], jeopardizing their own health and/or relying on this model for revenue, in which case they may not respond truthfully to screening questions (e.g. in regarding to infectious risk).

The study has several limitations, notable of which is reliance on blood centers’ reporting of results; there is a risk of misclassification of donors given that the distinction of family replacement from voluntary donors may be difficult. This could have led to an underestimation of the proportion of replacement donors, and possible overestimation of marker prevalence among voluntary donors. Multiplex nucleic acid testing was implemented in 2020 using an algorithm whereby resolution of testing at an individual virus level was only performed on samples that were discordant by NAT and serology. Therefore, the data were not included in this analysis, which raises a slight possibility of erroneous, unconfirmed serology results. However, these are unlikely to be associated with donor type so would not substantially impact the study conclusions.

Given the paucity of data on transfusion models in Eastern Europe and Western Asia, Georgia offers a model for other middle-income countries that are modernizing transfusion services in accordance with US and EU standards. The findings suggest continued improvement in blood transfusion safety in Georgia over the observation period, as reflected by a decline in prevalence of HCV and other infectious markers. The findings reiterate the importance of transitioning to an exclusive voluntary non-remunerated donor pool. They also underscore the importance of donor retention to advance blood transfusion safety.