Safety and Tolerability of Stribild in the Southeast United States
Purpose: The purpose of this study is to assess postmarketing safety and tolerability of Stribild (elvitegravir [EVG]/cobicistat [COBI]/tenofovir disoproxil fumarate [TDF]/emtricitabine [FTC]). Methods: A retrospective, pharmacoepidemiologic study in 2 outpatient HIV clinics in the Southeast United...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2016-09-01
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| Series: | Journal of the International Association of Providers of AIDS Care |
| Online Access: | https://doi.org/10.1177/2325957416650260 |
| _version_ | 1818313461838381056 |
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| author | Caroline Boyd Derrick PharmD, BCPS Zhiqiang Kevin Lu PhD Celeste Rudisill Caulder PharmD Elizabeth Kelly Hester PharmD, FCCP, BCPS Tyler David Wagner Paul Brandon Bookstaver PharmD, FCCP, BCPS |
| author_facet | Caroline Boyd Derrick PharmD, BCPS Zhiqiang Kevin Lu PhD Celeste Rudisill Caulder PharmD Elizabeth Kelly Hester PharmD, FCCP, BCPS Tyler David Wagner Paul Brandon Bookstaver PharmD, FCCP, BCPS |
| author_sort | Caroline Boyd Derrick PharmD, BCPS |
| collection | DOAJ |
| description | Purpose: The purpose of this study is to assess postmarketing safety and tolerability of Stribild (elvitegravir [EVG]/cobicistat [COBI]/tenofovir disoproxil fumarate [TDF]/emtricitabine [FTC]). Methods: 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). Results: 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. Conclusion: Our results demonstrate limited adverse events and low discontinuation rates associated with EVG/COBI/TDF/FTC. |
| first_indexed | 2024-12-13T08:34:07Z |
| format | Article |
| id | doaj.art-dc91337e3c04441e98f1e6a1120f0781 |
| institution | Directory Open Access Journal |
| issn | 2325-9574 2325-9582 |
| language | English |
| last_indexed | 2024-12-13T08:34:07Z |
| publishDate | 2016-09-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Journal of the International Association of Providers of AIDS Care |
| spelling | doaj.art-dc91337e3c04441e98f1e6a1120f07812022-12-21T23:53:42ZengSAGE PublishingJournal of the International Association of Providers of AIDS Care2325-95742325-95822016-09-011510.1177/2325957416650260Safety and Tolerability of Stribild in the Southeast United StatesCaroline Boyd Derrick PharmD, BCPS0Zhiqiang Kevin Lu PhD1Celeste Rudisill Caulder PharmD2Elizabeth Kelly Hester PharmD, FCCP, BCPS3Tyler David Wagner4Paul Brandon Bookstaver PharmD, FCCP, BCPS5 University of South Carolina School of Medicine, Columbia, SC, USA Department of Clinical Pharmacy and Outcomes Sciences, SC College of Pharmacy, University of South Carolina, Columbia, SC, USA Department of Clinical Pharmacy and Outcomes Sciences, SC College of Pharmacy, University of South Carolina, Columbia, SC, USA Department of Pharmacy Practice, Harrison School of Pharmacy, Auburn University, AL, USA SC College of Pharmacy, University of South Carolina, Columbia, SC, USA Department of Clinical Pharmacy and Outcomes Sciences, SC College of Pharmacy, University of South Carolina, Columbia, SC, USAPurpose: The purpose of this study is to assess postmarketing safety and tolerability of Stribild (elvitegravir [EVG]/cobicistat [COBI]/tenofovir disoproxil fumarate [TDF]/emtricitabine [FTC]). Methods: 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). Results: 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. Conclusion: Our results demonstrate limited adverse events and low discontinuation rates associated with EVG/COBI/TDF/FTC.https://doi.org/10.1177/2325957416650260 |
| spellingShingle | Caroline Boyd Derrick PharmD, BCPS Zhiqiang Kevin Lu PhD Celeste Rudisill Caulder PharmD Elizabeth Kelly Hester PharmD, FCCP, BCPS Tyler David Wagner Paul Brandon Bookstaver PharmD, FCCP, BCPS Safety and Tolerability of Stribild in the Southeast United States Journal of the International Association of Providers of AIDS Care |
| title | Safety and Tolerability of Stribild in the Southeast United States |
| title_full | Safety and Tolerability of Stribild in the Southeast United States |
| title_fullStr | Safety and Tolerability of Stribild in the Southeast United States |
| title_full_unstemmed | Safety and Tolerability of Stribild in the Southeast United States |
| title_short | Safety and Tolerability of Stribild in the Southeast United States |
| title_sort | safety and tolerability of stribild in the southeast united states |
| url | https://doi.org/10.1177/2325957416650260 |
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