(A-245) Safety and Effectiveness of B/F/TAF for the Treatment of HIV-1 Infection in a Large Cohort in South Korea: A Post-marketing Surveillance Study

Background: In 2022, there were 19,001 people living with HIV-1 (PWH) in South Korea (SK) with 1,066 incident cases (2.1 per 100,000 persons). In 2019, Bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF), a single tablet regimen for the treatment of HIV infection in treatment naïve (TN) and experienced (TE) patients who are virologically suppressed, was approved in SK.

Objectives: A post-marketing surveillance (PMS) study to assess the safety and effectiveness of B/F/TAF treatment in Korean PWH was conducted as part of the marketing authorization requirement in SK.

Methods: This prospective multicenter observational study followed PWH for up to 48 weeks after B/F/TAF start. Patients were continuously enrolled from 2019 to 2024, and clinical data were extracted from medical records using electronic case report forms. Incidence proportions of adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), and SADRs were calculated. The proportion of patients with virologic success, defined as HIV RNA < 50 copies per milliliter at 48 weeks after treatment start, was calculated as the effectiveness measure.

Results: The study included 2,761 Korean PWH. Mean (±standard deviation) age was 43.7±13.7 years, 93.5% were male, and 81.5% were TE.

1,850 AEs were reported in 1,026 (37.2%) patients. 108 SAEs were reported in 96 (3.5%) patients. 192 ADRs were reported in 149 (5.4%) patients. The most frequently reported ADRs were related to gastrointestinal disorders (42 ADRs, 38 [1.4%] patients). One SADR was reported in 1 patient. The proportions of patients with AEs and ADRs were higher in TN patients (AE: 55.9%, 95% confidence interval [CI]: 51.5-60.2%; ADR: 12.4%, 95% CI: 9.6%-15.5%) compared to TE patients (AE: 32.9%, 95% CI: 31.0-39.0%; ADR: 3.8%, 95% CI: 3.1-4.7%). B/F/TAF was discontinued before 48 weeks in 262 (9.5%) patients due to lost to follow-up (n=161, 5.8%), AE (n=53, 1.9%), and other unspecified reasons (n=48, 1.7%). No deaths occurred during the study.

Among 2,137 patients with HIV RNA levels at 48 weeks, virologic success was achieved in 97.2% (95% CI: 96.4-97.9%) patients and was higher in TE patients (97.8%, 95% CI: 97.1-98.5%) compared to TN patients (93.8%, 95% CI: 90.7-96.1%).

Conclusions: Safety and effectiveness findings from this PMS study in SK were consistent with the known safety and effectiveness profile of B/F/TAF. As expected, TN patients experienced more AEs/ADRs and virologic failure compared to TE patients. However, safety events remained low ( < 6% patients with ADRs), and virologic success was above 90% in TN and TE patients. B/F/TAF for the treatment of HIV-1 infection was safe and effective in a real-world cohort of Korean PWH.