Results of three multicenter observational studies of regimens containing tenofovir alafenamide among people with HIV in Japan.

BACKGROUND

Safety data on tenofovir alafenamide (TAF)-containing regimens with >2 years' follow-up in large cohorts of people with HIV (PWH) in Japan are limited. We evaluated the safety of TAF-containing regimens among PWH in Japan, including combinations with emtricitabine (F/TAF), elvitegravir/cobicistat/emtricitabine (E/C/F/TAF), and bictegravir/emtricitabine (B/F/TAF).

METHODS

Data were collected from medical records for three separate single-arm studies from the HIV-Related Drugs multicenter observational joint cooperative surveillance. Data cut-off periods for each study were: F/TAF, January 2017-April 2025; E/C/F/TAF, July 2016-November 2024; and B/F/TAF, April 2019-February 2025. Each cohort was managed independently and analyzed descriptively as a separate observational cohort, without cross-cohort comparative analyses.

RESULTS

Safety analyses for the studies included 1678 patients who received F/TAF, 659 who received E/C/F/TAF, and 1495 who received B/F/TAF; 22.2%-35.2% of patients were treatment-naïve across the three TAF-containing products. Median (quartile [Q]1, Q3) treatment duration was 5.12 (2.50, 6.89), 3.10 (2.38, 6.00), and 3.00 (1.28, 4.48) years. Adverse drug reactions (ADRs) occurred in 12.0%-18.6% of patients across studies. The most common ADRs by preferred term were: F/TAF, hypertension (23 [1.4%]) and hyperuricemia (22 [1.3%]); E/C/F/TAF, dyslipidemia (9 [1.4%]) and insomnia (6 [0.9%]); and B/F/TAF, weight increased (32 [2.1%]) and insomnia (18 [1.2%]). Most ADRs initially occurred within the first six months of treatment. The frequency of serious ADRs was <5%; 1.3%-2.9% discontinued treatment due to ADRs.

CONCLUSIONS

The findings from these studies are consistent with the known safety profiles of the three TAF-containing products. No new safety issues emerged.