The safety and tolerability of oral TDF/FTC as pre-exposure prophylaxis among men who have sex with men in China: a prospective cohort study

BACKGROUND: Pre-exposure prophylaxis (PrEP) has been demonstrated as an effective strategy for preventing HIV infection. However, multiple barriers contribute to its suboptimal uptake in China, with drug safety being a shared concern for both clinicians and patients. This study aimed to assess the safety and tolerability of oral tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) for PrEP in a real-world setting in China. METHODS: An open-label, prospective cohort study was conducted between September 2021 and September 2024 in Wuhan and Guangzhou, China. PrEP-eligible men who have sex with men (MSM) were enrolled, participants were prescribed TDF/FTC as PrEP and followed up for 12 months. Adverse events (AEs) were self-reported, and participants underwent regular monitoring for HIV, syphilis, liver and kidney function during follow-up. RESULTS: A total of 1,138 participants enrolled and initiated PrEP, with 1,045 completing at least one follow-up visit. Seven participants were diagnosed with HIV infection, yielding an HIV incidence rate of 0.8 per 100 person-years (95% CI: 0.2-1.4). A total of 62 participants self-reported 106 AEs, the majority of which were grade 1, with no serious AEs observed. Participants reported a significantly higher AE incidence with daily PrEP than on-demand PrEP (14.7 per 100 person-years vs. 9.3 per 100 person-years, P < 0.05). Additionally, 128 episodes of serum creatinine (SCr) and 701 episodes of liver enzyme abnormalities were recorded, and mild elevations in ALT, AST, and SCr were significantly more frequent among participants taking the daily regimen. Significant ALT elevations were observed from the 1st month to the 9th month follow-up, while SCr elevations occurred predominantly in the 1st month. CONCLUSIONS: Both daily and on-demand PrEP regimens with TDF/FTC are safe and well tolerated for the prevention of HIV among Chinese MSM. On-demand PrEP with fewer AEs and comparable effectiveness provides an alternative HIV prevention strategy for Chinese MSM in real-world settings. TRIAL REGISTRATION: The study is registered in Clinical Trial databases in China (ChiCTR2100048981, July 19, 2021) and the US (NCT04754139, February 11, 2021).