Bictegravir (BIC)/emtricitabine (FTC)/tenofovir alafenamide (TAF) was Food and Drug Administration approved in February 2018. The paucity of real-world data prompted this retrospective, observational evaluation of discontinuation rates, adverse effects, and virologic control. In a Southern US, predominantly African American overweight population, we found optimal virologic control and low discontinuation rates, with 4% discontinuing BIC/FTC/TAF due to rash, low platelets, loss of appetite, and insomnia.
Sphingomonas paucimobilis usually exhibits low virulence likely secondary to its lack of lipopolysaccharide A. Infections caused by S. paucimobilis more commonly afflict immunocompromised patients. Some case reports document pneumonia, osteomyelitis, pyomyoma, and septic arthritis secondary to S. paucimobilis in immunocompetent patients.S. paucimobilis bacteremia is associated with underlying conditions, including malignancy, diabetes mellitus, end-stage renal disease, and chronic obstructive pulmonary disease. Bacteremia has the potential to lead to septic shock. Antimicrobial effectiveness varies, and the mechanism that leads to resistance has not yet been elucidated. This underscores the importance of antimicrobial susceptibility testing.We present a unique case of community-acquired S. paucimobilis bacteremia and resultant septic shock in an immunocompetent patient. A 90-year-old female with a history of chronic kidney disease, acute colonic infarction status post colostomy, gastroesophageal reflux disease, hypertension, supraventricular tachycardia, and schizoaffective disorder presented to the emergency department with hypotension and altered mental status. Urinalysis and chest X-ray were unremarkable. Antibiotic therapy with cefepime was initiated following gram stain, which showed gram-negative rods. The blood culture revealed S. paucimobilis. The patient was discharged with the plan to enter hospice care.
BackgroundBictegravir (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.MethodsThis 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.ResultsA 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/m2 and 77 (38%) had a BMI of ≥ 30 kg/m2. At baseline, 146 (72.6%) had virologic suppression (VS) (< 200 copies/mL) with a mean CD4 count of 529 cells/mm3 (range < 35–1573 cells/mm3). 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.ConclusionIn 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.
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