(287) Safety Results of Post-Marketing Surveillance Studies of B/F/TAF in China and South Korea

Background: B/F/TAF is a once-daily single tablet regimen used to treat people with HIV-1 (PWH). B/F/TAF was approved in China and South Korea (SK) in 2019. Post Marketing Surveillance (PMS) studies are a requirement in several countries of the Asia-Pacific area.

Objectives: The purpose of these PMS studies was to collect and describe information on Adverse Events (AEs) and Adverse Drug Reactions (ADRs) in PWH treated with B/F/TAF.

Methods: Two large multicenter observational studies that collected and described information on Adverse Events (AEs) and Adverse Drug Reactions (ADRs) in PWH treated with B/F/TAF were conducted in China and SK. PWH were followed for safety events from the start of treatment up to 108 weeks. In both studies the data were extracted from medical records. Due to different regulatory requirements, the data from China are based on the final clinical study report (May21-Jun23), while for SK the data are based on an annual interim report (Jan22-Jan23).

Results: In China 2982 PWH were included from 34 sites (May21-Jun23). In SK 1157 PWH were included from 45 sites (Jan22-Jan23). Mean (± standard deviation) age was 38.8 (±11.8) years in China, and 43.3 (±13.7) years in SK. Most participants (% [n]) were male (China: 91.9% [2740]; SK: 93.3% [1080]), and most were antiretroviral therapy (ART)-experienced (China: 71.0% [2118]; SK: 89.3% [1033]). The incidence of AEs and ADRs % (n) were 34.2% (1019) and 17.1% (509) in China and 36.7% (425) and 5.5% (63) in SK, respectively. Serious AEs were reported in 4.5% (133) and 3.5% (41) of participants in China and SK, respectively. Serious ADRs were reported in 0.1% (2) participants in China; none were reported in SK.

In China, less than 1% of PWH had AEs or ADRs leading to discontinuation of B/F/TAF (22 and 9/2982, respectively). Frequency of AEs was higher in ART-naïve versus ART-experienced PWH (37% vs 33%, p = 0.037). The most frequent ADRs (≥ 1%) by preferred term (PT) were: weight increased (5.3%), hyperuricaemia (4%), hyperlipidaemia (3.5%), hepatic function abnormal (2.2%) and renal impairment (1.5%).

In SK 1.8% (21) of PWH had AEs leading to discontinuation of B/F/TAF. Frequency of AEs was higher in ART-naïve versus ART-experienced PWH (54.8% vs 34.6%, p>0.001). There were no ADRs by PT with a frequency of ≥ 1%.

Conclusions: No new and significant safety issues emerged from the PMS studies in China and SK. The safety findings from these PMS studies are consistent with the known safety profile of B/F/TAF. The higher proportion of ADRs in China may be attributed to the use of binary causality assessment categories as well as a higher proportion of treatment naïve PWH, who are more prone to experiencing AEs/ADRs. Overall, the benefit-risk balance of B/F/TAF in the approved indication remains positive and unchanged in both countries.