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 prophylaxis (PrEP) medication has sparked fear on the possible increase of human immunodeficiency virus (HIV) 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 We developed an efficient and cost-effective method for detecting ART drugs in blood donors. And this method was used to assess the prevalence of ART drug use in high-risk blood donors who were positive with anti-HIV and/or anti-Treponema pallidum (anti-TP) in Shenzhen, China. 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 (HIV positive blood donors who regularly take ART drugs, n = 3) and their gradient diluted samples, Group-B (repeated blood donors, n = 86), Group-C (anti-HIV positive/anti-TP negative blood donors, n = 77), Group-D (anti-HIV negative/anti-TP positive blood donors, n = 353) and Group-E (anti-HIV positive/anti-TP positive blood donors, n = 23) and they were all screened from 440 000 blood donors 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 negative/anti-TP positive donations (Group-D). 3 positive ART drugs (Efavirenz, lamivudine, lopinavir, ritonavir, tenofovir and zidovudine) samples in Group-C (anti-HIV positive/anti-TP negative, 3 out of 77 screened, 3.9%), and 1 sample with efavirenz, lamivudine and tenofovir in Group-E (anti-HIV positive/ anti-TP positive, 1 out of 23 screened, 4.4%) were detected in 1:2 pooled plasma samples. The ART drugs can still be detected even after the pooled plasma was diluted at 1:6. In addition, HIV RNA was not detectable in one of the 4 ART positive donations. Conclusion 3.9–4.4% of anti-HIV positive donors use ART drugs in Shenzhen China, 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 replication below detectable level.