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- Title
Safety and Tolerability of Stribild in the Southeast United States.
- Authors
Derrick, Caroline Boyd; Lu, Zhiqiang Kevin; Caulder, Celeste Rudisill; Hester, Elizabeth Kelly; Wagner, Tyler David; Bookstaver, Paul Brandon
- Abstract
<bold>Purpose: </bold>The purpose of this study is to assess postmarketing safety and tolerability of Stribild (elvitegravir [EVG]/cobicistat [COBI]/tenofovir disoproxil fumarate [TDF]/emtricitabine [FTC]).<bold>Methods: </bold>A retrospective, pharmacoepidemiologic study in 2 outpatient HIV clinics in the Southeast United States was conducted among adults receiving EVG/COBI/TDF/FTC. We evaluated incidence and treatment-related adverse events, including change in serum creatinine (SCr).<bold>Results: </bold>Patients were primarily treatment experienced (n = 173, 60%), African American (n = 210, 73%), and males (n = 187, 65%). One hundred ninety-five (68%) patients had any increase in SCr, and 65 (23%) had an increase of ≥0.3 mg/dL. Mean SCr change from baseline to peak was 0.2 mg/dL. Being treatment experienced (odds ratio [OR] = 2.21, 95% confidence interval [CI]: 1.12-4.38) was associated with SCr ≥0.3 mg/dL, while body mass index ≥30 kg/m(2) (OR = 0.41, 95% CI: 0.18-0.93) was protective. Twenty (7%) patients discontinued therapy, 3 due to acute kidney injury.<bold>Conclusion: </bold>Our results demonstrate limited adverse events and low discontinuation rates associated with EVG/COBI/TDF/FTC.
- Subjects
TENOFOVIR; PHARMACOEPIDEMIOLOGY; CREATININE; ACUTE kidney failure; BISOPROLOL; EMTRICITABINE
- Publication
Journal of the International Association of Providers of AIDS Care, 2016, Vol 15, Issue 5, p432
- ISSN
2325-9582
- Publication type
journal article
- DOI
10.1177/2325957416650260