2489. Adverse Events with Biktarvy: Post-Marketing Study

BACKGROUND: Bictegravir (BIC)/emtricitabine (FTC)/tenofovir alafenamide (TAF) was FDA approved in February 2018. There are no published post-marketing data evaluating safety and efficacy. After large uptake of BIC/FTC/TAF at our institution, reports of rash prompted a real-world review. The purpose of this study was to assess one year post-marketing safety and tolerability of BIC/FTC/TAF. METHODS: This retrospective, observational, pharmacoepidemiologic study was conducted one year post-approval of BIC/FTC/TAF, between February 2018 and March 2019 at the University of South Carolina Immunology Center. Adults receiving BIC/FTC/TAF were included. Drug discontinuation and treatment-related adverse effects were evaluated. Baseline demographics and serial laboratory data were collected. RESULTS: A total of 201 patients were assessed. Of those, the majority were treatment experienced (181, 90%), African American (137, 68%) males (132, 65%) with a mean age of 46 years (range 20–76 years). Four patients were transgender. 135 (67%) had a BMI of ≥ 25 kg/m(2) and 77 (38%) had a BMI of ≥ 30 kg/m(2). At baseline, 146 (72.6%) had virologic suppression (VS) (< 200 copies/mL) with a mean CD4 count of 529 cells/mm(3) (range < 35–1573 cells/mm(3)). VS was maintained in 145/146 and subsequently reached in 47/55 (85.5%) at first follow-up. Of the 201, 18 (8.9%) patients reported adverse drug events (ADEs) for a total of 19 events (10 rash, 2 dizziness, 1 nausea/vomiting, 1 headache, 1 diarrhea, 1 loss of appetite, 1 weight gain, 1 fatigue, 1 insomnia). Eleven (5%) patients discontinued therapy; nine (4%) due to ADEs (7 rash, 1 insomnia and loss of appetite, and 1 feeling unwell). One patient with high AST/ALT at baseline increased from 129/243 U/L to 234/394 U/L, respectively. No other laboratory abnormalities were reported. CONCLUSION: In a southern, predominantly African American overweight population, our results demonstrate low discontinuation rates associated with BIC/FTC/TAF, with rash being the predominate cause. Overall, 4% discontinued BIC/FTC/TAF due to ADEs compared with 1% as reported in the package insert. VS rates were high throughout the evaluation period. Ongoing post-marketing evaluation is important for early recognition of unexpected adverse outcomes. DISCLOSURES: All authors: No reported disclosures.