A preliminary survey on the use of ART among blood donors in Shenzhen China and its implications to blood safety.

IMPORTANCE: The recent introduction of the AIDS pre-exposure or post-exposure prophylaxis (PrEP/PEP) medication has sparked fear of the possible increase of human immunodeficiency virus (HIV) and Treponema pallidum (TP) transfusion-transmission risk due to the potential administration of antiretroviral therapy (ART) in blood donors. However, the extent to which ART drugs are currently being utilized by blood donors in China remains to be clarified. OBJECTIVE: To assess the prevalence of ART drug use in individuals who attempted to donate blood but were eventually rejected due to anti-HIV and/or anti-Treponema pallidum (anti-TP) reactive in Shenzhen, China and to elucidate the characteristics of these high-risk cohorts using anonymised individual-level data. DESIGN: High pressure liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS) was used to measure the concentrations of 8 ART drugs in plasma samples collected from the following 5 groups: Group-A (individuals with anti-HIV screened reactive who regularly take ART drugs, n = 3) and their gradient diluted samples, Group-B (repeated blood donors, n = 86), Group-C (anti-HIV reactive/anti-TP non-reactive screened individuals, n = 77), Group-D (anti-HIV non-reactive/anti-TP reactive screened individuals, n = 353) and Group-E (anti-HIV reactive/anti-TP reactive screened individuals, n = 23). And they were all identified from 440 000 screened individuals who came to donate in Shenzhen Blood Center from 2019 to 2023. RESULTS: No ART drugs were detected in all the 86 plasma samples from repeated blood donors (Group-B) or in 353 plasma samples from anti-HIV non-reactive/anti-TP reactive screened individuals (Group-D). 3 positive ART drugs (Efavirenz, lamivudine, lopinavir, ritonavir, tenofovir and zidovudine) samples in Group-C (anti-HIV reactive/anti-TP non-reactive, 3 out of 77 screened), and 1 sample with efavirenz, lamivudine and tenofovir in Group-E (anti-HIV reactive/ anti-TP reactive, 1 out of 23 screened) were detected in 1:2 pooled plasma samples. The ART drugs could still be detected even after the pooled plasma was further diluted at 1:6. In addition, HIV RNA was not detectable in one of the 4 ART positive screened individuals. CONCLUSION: ART drugs were detected in 4(4/100) anti-HIV reactive plasma samples screened from 440 000 donations in Shenzhen, which indicated some HIV-infected people who take ART drugs donate blood without disclosing their health and medical histories and this may endanger blood safety because ART may compromise current screening strategies by suppressing HIV RNA replication below the detectable level. CLINICAL TRIAL NUMBER: Not applicable.