Treatment of acute bacterial skin and skin structure infection with single-dose dalbavancin in persons who inject drugs

Article Details

Authors
Pedro Luis Gonzalez MD, MT, Urania Rappo MD, Karthik Akinapelli MS, Jennifer S McGregor RPh, Sailaja Puttagunta MD, Michael W Dunne MD

Article Type
Original Research

DOI
10.7573/dic.212559

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Abstract

Background: Persons who inject drugs (PWID) are at increased risk of acute bacterial skin and skin structure infections (ABSSSIs), a growing healthcare concern. Multiple medical, social, and economic issues, including adherence and comorbidities, complicate the medical care of the PWID population, adversely affecting patient outcomes.

Methods: We assessed demographics and outcomes for the PWID population in a double-blind trial of 698 patients randomized to dalbavancin 1500 mg as a single intravenous (IV) infusion or as a 2-dose regimen (1000 mg IV on day 1; 500 mg IV on day 8) for ABSSSI. The primary endpoint was ≥20% reduction in erythema at 48–72 hours in the intent-to-treat population; clinical status was also assessed at days 14 and 28.

Results: There were 212/698 (30.4%) patients with a history of injection drug use in this clinical trial. Dalbavancin efficacy was similar between the single- and 2-dose therapy groups in the PWID and non-PWID populations at all timepoints. Dalbavancin was well tolerated in the PWID population, with similar rates of adverse events as the non-PWID population.

Conclusion: Dalbavancin as a single-dose or 2-dose regimen had similar efficacy for the treatment of ABSSSI at all timepoints in the PWID and non-PWID populations. A single 30-minute IV infusion would eliminate the need for indwelling IV access. The convenience of a single dose supervised in a health setting may also optimize treatment adherence in the PWID population.

Keywords: dalbavancin, infectious disease, intravenous, methicillin-resistant Staphylococcus aureus, skin infection, staphylococcal, substance abuse.

Citation: Gonzalez PL, Rappo U, Akinapelli K, McGregor JS, Puttagunta S, Dunne MW. Treatment of acute bacterial skin and skin structure infection with single-dose dalbavancin in persons who inject drugs. Drugs in Context 2018; 7: 212559. DOI: 10.7573/dic.212559

Contributions: All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosure and potential conflicts of interest: Dr Gonzalez is an employee of Allergan plc and receives stock in the company. Dr Rappo is an employee of Allergan plc and holds stock in the company. Mr Akinapelli has no conflicts of interest to disclose. Ms McGregor is an employee of Allergan plc and receives stock in the company. Drs Puttagunta and Dunne were employees of Allergan plc at the time of study conduct and analysis. Neither honoraria nor payments were made for authorship. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors are available for download at https://www.drugsincontext.com/wp-content/uploads/2018/11/dic.212559-COI.pdf

Acknowledgments: Data have been presented in part as a poster presentation at the American Society for Microbiology meeting on June 16–20, 2016, in Boston, Massachusetts. Writing and editorial assistance was provided to the authors by Lee Hohaia, PharmD, and John E Fincke, PhD, at Complete Healthcare Communications, LLC (North Wales, PA), a CHC Group company. The authors would like to acknowledge Lei Luo, MPH, and Xiaoshu Xu, MS, for additional statistical support. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.

Funding declaration: Sponsorship for this study was funded by Allergan plc (Dublin, Ireland). Support for writing and editorial assistance, and for article processing charges were funded by Allergan plc.

Copyright: Copyright © 2018 Gonzalez PL, Rappo U, Akinapelli K, McGregor JS, Puttagunta S, Dunne MW. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Correct attribution: Copyright © 2018 Gonzalez PL, Rappo U, Akinapelli K, McGregor JS, Puttagunta S, Dunne MW. https://doi.org/10.7573/dic.212559. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0.

Article URL: https://www.drugsincontext.com/treatment-of-acute-bacterial-skin-and-skin-structure-infection-with-single-dose-dalbavancin-in-persons-who-inject-drugs

Correspondence: Pedro Luis Gonzalez, Allergan plc, 5 Giralda Farms, Madison, NJ 07940, USA. pedro.gonzalez@allergan.com

Provenance: submitted; externally peer reviewed.

Submitted: 17 September 2018; Peer review comments to author: 12 October 2018; Revised manuscript received: 13 November 2018; Accepted: 13 November 2018; Publication date: 11 December 2018.

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