Published Online: February 23, 2015. doi:10.1001/jama.2015.1373.
Study concept and design: Osinusi, Kohli, Nelson, Sajadi, Teferi, Wood, Subramanian, Pang, McHutchison, Polis, Masur, Kottilil.
Acquisition, analysis, or interpretation of data: Osinusi, Townsend, Kohli, Nelson, Seamon, Meissner, Bon, Silk, Gross, Price, Sidharthan, Sims, Herrmann, Hogan, Talwani, Proschan, Jenkins, Kleiner, Wood, Subramanian, Fauci, Masur, Kottilil.
Drafting of the manuscript: Osinusi, Townsend, Bon, Gross, Price, Herrmann, Wood, Masur, Kottilil.
Critical revision of the manuscript for important intellectual content: Osinusi, Townsend, Kohli, Nelson, Seamon, Meissner, Bon, Silk, Sajadi, Sidharthan, Sims, Herrmann, Hogan, Teferi, Talwani, Proschan, Jenkins, Kleiner, Wood, Subramanian, Pang, McHutchison, Polis, Fauci, Masur, Kottilil.
Statistical analysis: Osinusi, Townsend, Meissner, Bon, Herrmann, Proschan, Kottilil.
Obtained funding: Masur, Kottilil.
Administrative, technical, or material support: Townsend, Kohli, Nelson, Seamon, Meissner, Silk, Gross, Sajadi, Sidharthan, Sims, Teferi, Wood, Subramanian, Pang, McHutchison, Masur, Kottilil.
Study supervision: Osinusi, Kohli, Pang, McHutchison, Polis, Fauci, Masur, Kottilil.
Review and critique of the manuscript: All authors.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Ms Gross reported receiving study medication from Gilead for another study and holding stock in Merck and Pfizer. Dr Hogan reported serving as a speaker or consultant for Gilead and VIV and serving as a speaker for Merck, Bristol-Myers Squibb, Abbott, and Boehringer Ingelheim. Dr Teferi reported receiving grants and personal fees from Gilead. Dr Talwani reported serving as a speaker for Gilead. No other disclosures are reported.
Funding/Support: The Regulatory Compliance and Human Participants Protection Branch of the National Institute of Allergy and Infectious Diseases (NIAID) served as the study sponsor. This project has been funded in whole or in part with federal funds from the National Cancer Institute, National Institutes of Health (NIH), under contract HHSN261200800001E. This research was supported in part by the NIAID. The study was also supported in part by the German Research Foundation (DFG) by the clinical research unit KFO 129. The study was partially funded by a Collaborative Research and Development Agreement between NIH and Gilead Sciences.
Role of the Funder/Sponsors: Gilead Sciences provided the study drug. The Regulatory Compliance and Human Participants Protection Branch was involved in the review and approval of the study via the usual peer review process as well as the study management but had no role in the design of the study; data collection and analysis; interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Drs Osinusi, Subramanian, Pang, and McHutchison, employees of Gilead Sciences Inc, participated in the writing of the manuscript.
Disclaimer: The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US government.
Previous Presentations: Presented in part at the 49th Annual Meeting of the European Association for the Study of Liver Diseases (EASL): The International Liver Congress; April 9-13, 2014; London, United Kingdom; and at the 65th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); November 7-11, 2014; Boston, Massachusetts.
Additional Contributions:We would like to acknowledge the contributions of the following individuals: Katie Watkins, BS, Erin Rudzinski, BS, and Susan Vogel, RN, BSN (clinical monitoring support), Judith Starling, PharmD, William T. Symonds, PharmD, and Lori Gordon (pharmacy), Vanessa Eccard, BS, Jerome Pierson, PhD, John Tierney, BSN, MPM (regulatory support); William Ronnenberg, JD/MIP, MS, Richard Williams, PhD, and Mike Mowatt, PhD (technology transfer support), Marc Teitelbaum, MD, CPI (sponsor medical monitor), Mary Hall (protocol support), Cathy Rehm, Sarah Jones, David Wu, BS, Leighton Daigh, BS, and Jessica Johl, BS (laboratory support), Richard Kwan, PAC, Lisa L. Barrett, MD, PhD, Tim Jolley, RN, Gabbie Diaz, RN, Jose Chavez, MD, Stephen Abbott, MD, Colleen Kotb, NP, Angie Price, NP, Tess Petersen, BS, Josez Chavez, MD, and Senora Mitchell (clinic support).